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Emergo Consulting (UK) Limited

Authorized Representative in the United Kingdom

Compass House, Vision Park Histon c/o Cr360 – UL International

Cambridge, England, United Kingdom

Postcode: CB24 9BZ

Relationship Type: UK Responsible Person
4211 Products Represented
580 Manufacturers
Total Products
4211
Manufacturers
580
Device Types
5
Generic Names
2241
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (4211)
Complete portfolio registered with MHRA

Bone fixation plate pliers insert

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Bone awl, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Bone nail driver

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Bone nail end-cap

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Bone nail guidewire, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Bone approximation clamp

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Wire cutter

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical torque wrench, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical screwdriver, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical screwdriver, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical drill guide, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical drill guide, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical countersink, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Skin marking sticker

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic surgical distractor, internal

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic reamer guide

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implantation sleeve, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implantation sleeve, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implant calibration pin

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implant calibration pin

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone wire

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone wire

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

External orthopaedic fixation frame calculation software

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

External orthopaedic fixation system, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

External orthopaedic fixation system, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

External orthopaedic fixation system, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

External orthopaedic fixation system, single-use

Manufacturer:

Orthofix S.r.l.

Type:

System or Procedure Pack

Registration Date:

N/A

External orthopaedic fixation system, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

External orthopaedic fixation system, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Femur nail

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Fluted surgical drill bit, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Fluted surgical drill bit, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Fluted surgical drill bit, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Fluted surgical drill bit, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Fluted surgical drill bit, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

General internal orthopaedic fixation system implantation kit

Manufacturer:

Orthofix S.r.l.

Type:

System or Procedure Pack

Registration Date:

N/A

General internal orthopaedic fixation system implantation kit

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

General internal orthopaedic fixation system implantation kit

Manufacturer:

Orthofix S.r.l.

Type:

System or Procedure Pack

Registration Date:

N/A

Hard-tissue ultrasonic surgical system

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Hard-tissue ultrasonic surgical system

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Humerus nail

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Medical ruler, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Medical ruler, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone nut

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone washer, non-sterile

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone washer, non-sterile

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone wire

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone wire

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone wire

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone-reduction tool

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic fixation plate, non-bioabsorbable, sterile

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implant aiming arm

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implant impactor, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implant inserter/extractor, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implantation hammering attachment

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic reamer guide

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic surgical distractor, internal

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic trocar blade, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic trocar blade, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone wire

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical mallet

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Medullary canal orthopaedic reamer, rigid

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical instrument handle, non-torque-limiting

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical drill guide, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical implant template, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical screwdriver, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical torque wrench, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Tibia nail

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Medullary canal orthopaedic reamer, flexible

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Instrument tray, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Instrument tray, reusable

Manufacturer:

Orthofix S.r.l.

Type:

System or Procedure Pack

Registration Date:

N/A

Hard-tissue ultrasonic surgical system

Manufacturer:

Orthofix S.r.l.

Type:

System or Procedure Pack

Registration Date:

N/A

Hard-tissue ultrasonic surgical system

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

General internal orthopaedic fixation system implantation kit

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

General internal orthopaedic fixation system implantation kit

Manufacturer:

Orthofix S.r.l.

Type:

System or Procedure Pack

Registration Date:

N/A

General internal orthopaedic fixation system implantation kit

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

General internal orthopaedic fixation system implantation kit

Manufacturer:

Orthofix S.r.l.

Type:

System or Procedure Pack

Registration Date:

N/A

Fluted surgical drill bit, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Fluted surgical drill bit, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Flexible bone nail

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

External orthopaedic fixation system, single-use

Manufacturer:

Orthofix S.r.l.

Type:

System or Procedure Pack

Registration Date:

N/A

External orthopaedic fixation system, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

External orthopaedic fixation system, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

External orthopaedic fixation system, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Cannulated surgical drill bit, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Cannulated surgical drill bit, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Bone-nailing spacer

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Bone nail guidewire, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Bone nail guidewire, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Manual blood lancing device, single-use

Manufacturer:

Tasso, Inc.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implant aiming/guiding block, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Wire cutter

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Wire cutter

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical torque wrench, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical screwdriver, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical screwdriver, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical screwdriver, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical screwdriver, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical instrument handle, non-torque-limiting

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical instrument handle, non-torque-limiting

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical implant template, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical drill guide, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Surgical countersink, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Radiology PACS software

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic reamer guide

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implantation sleeve, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implantation hammering attachment

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implant calibration pin

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implant aiming/guiding block, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implant aiming/guiding block, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic implant aiming arm

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic fixation plate, non-bioabsorbable, sterile

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone-reduction tool

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone wire

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone wire

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone washer, sterile

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Medullary canal orthopaedic reamer, rigid

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Medullary canal orthopaedic reamer, flexible

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Medical ruler, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Manual surgical rotary handpiece, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Manual orthopaedic bender, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Hard-tissue ultrasonic surgical system

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Hard-tissue ultrasonic surgical system

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Hard-tissue ultrasonic surgical system

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

General internal orthopaedic fixation system implantation kit

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

General internal orthopaedic fixation system implantation kit

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

General internal orthopaedic fixation system implantation kit

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Fluted surgical drill bit, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Fluted surgical drill bit, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Fluted surgical drill bit, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

External orthopaedic fixation system, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

External orthopaedic fixation system, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

External orthopaedic fixation system, single-use

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

External orthopaedic fixation system, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Bone nail guidewire, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Bone nail guidewire, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Bone distraction forceps

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Arthrodesis nail

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

N/A

Multidisciplinary medical image management software

Manufacturer:

oneFIT medical

Type:

General Medical Device

Registration Date:

N/A

Incontinence pants liner

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

N/A

Radiation therapy software

Manufacturer:

Oncology Data Systems, Inc.

Type:

General Medical Device

Registration Date:

N/A

Orthopaedic/craniofacial implantation planning software

Manufacturer:

oneFIT medical

Type:

General Medical Device

Registration Date:

N/A

Joint prosthesis implantation kit, single-use

Manufacturer:

oneFIT medical

Type:

General Medical Device

Registration Date:

N/A

Polymer-metal oesophageal stent

Manufacturer:

BCM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

Manufacturer:

Bolder Surgical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical gas pipeline system

Manufacturer:

CAHOUET

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical system

Manufacturer:

Fractyl Health, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transport infant incubator

Manufacturer:

International Biomedical, Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glaucoma micro-stent

Manufacturer:

Ivantis, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical system

Manufacturer:

Jeisys Medical Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Apheresis system filter, plasma

Manufacturer:

Marker Americas LP

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/orthopaedic lavage control unit

Manufacturer:

Medaxis AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal duodenal stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal duodenal stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal pancreatic stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal tracheal/bronchial stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary angiographic x-ray system, digital

Manufacturer:

Neusoft Medical Systems Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glaucoma shunt

Manufacturer:

New World Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment clinical data interfacing software

Manufacturer:

Nonin Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulse oximeter

Manufacturer:

Nonin Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulse oximeter probe, single-use

Manufacturer:

Nonin Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic male condom, Hevea-latex

Manufacturer:

OKAMOTO RUBBER PRODUCTS CO.,LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Olsen Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, single-use

Manufacturer:

Olsen Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical electrode, monopolar, single-use

Manufacturer:

Olsen Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

Manufacturer:

Olsen Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary angiographic x-ray system, digital

Manufacturer:

Omega Medical Imaging, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye lubricant

Manufacturer:

Oy Finnsusp Ab

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone nail guidewire, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tap, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tap, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip internal fixation system

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic guidewire, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant driver

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic instrument surgical connector

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Partial wrist radius prosthesis

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical countersink, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant driver

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant template, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant template, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant template, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant/trial-implant/sizer holder, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant/trial-implant/sizer holder, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical power tool adaptor

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Total wrist prosthesis

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body aspiration needle, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone approximation clamp

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone curette, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone file/rasp, manual, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone hook

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Common bile duct dilator

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device sterilization/disinfection container, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing/utility forceps, scissors-like, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ear knife

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENT probe, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eyelid speculum, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixed-diameter cervical dilator, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastro-urological guidewire, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose surgical scissors, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held surgical retractor, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery ligation clip applier

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic knife, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgical probe, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic chisel

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic osteotome

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Self-retaining surgical retractor, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin grafting knife

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft-tissue surgical hook, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal rongeur

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal rongeur

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical mallet

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical tamp, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing needle holder, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Towel clamp, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urethral sound, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal speculum, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vessel approximator

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wire cutter

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal tracheal/bronchial stent

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biliary/urinary stone retrieval basket, single-use

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible endoscopic biopsy forceps, single-use

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal colonic stent

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal duodenal stent

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal oesophageal stent

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI system application software

Manufacturer:

NeoSoft LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental elevator, sinus lift

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental soft-tissue coring punch, reusable

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, medicated, reusable

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing-fixation skin adhesive tape, non-silicone

Manufacturer:

Neotech Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye mask

Manufacturer:

Neotech Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Frame/rail/pole device holder

Manufacturer:

Neotech Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient tube cushion

Manufacturer:

Neotech Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pressure bandage, non-latex, single-use

Manufacturer:

Neotech Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wearable percutaneous catheter/tube holder

Manufacturer:

Neotech Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electroencephalographic electrode cap, reusable

Manufacturer:

Neuroelectrics Barcelona S.L.U

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transcutaneous electrical stimulation electrode, reusable

Manufacturer:

Neuroelectrics Barcelona S.L.U

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin stapler/staple, non-bioabsorbable

Manufacturer:

NewGen Surgical INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adhesive bandage

Manufacturer:

NICHIBAN CO.,LTD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood/blood culture specimen transfer spike IVD

Manufacturer:

ITL Asia Pacific Sdn. Bhd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Limb tourniquet, manual, reusable

Manufacturer:

ITL Asia Pacific Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sharp surgical instrument counting tray/pad, single-use

Manufacturer:

ITL Asia Pacific Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument containment holder, single-use, non-sterile

Manufacturer:

ITL Asia Pacific Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument interim-placement holder, single-use

Manufacturer:

ITL Asia Pacific Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Syringe/blood collection tube adaptor IVD

Manufacturer:

ITL Asia Pacific Sdn. Bhd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoelectric hand prosthesis

Manufacturer:

Taska Prosthetics, Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Psychophysiological biofeedback system

Manufacturer:

Thought Technology Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrode conductive medium

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical return electrode, single-use

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical tip cleaning pad

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment handle cover, single-use

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vein stripper, single-use

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Chemical/physical sterilization process indicator

Manufacturer:

Terragene S A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endotracheal tube holder

Manufacturer:

TIDI Product, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye pad

Manufacturer:

TIDI Product, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment/instrument drape, single-use

Manufacturer:

TIDI Product, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urinary catheter holder

Manufacturer:

TIDI Product, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin kit

Manufacturer:

Tokuyama Dental Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material injection cannula, single-use

Manufacturer:

Tokuyama Dental Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Donor-organ preservation/transport perfusion set vessel tie tool

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Donor-organ preservation/transport system gas cylinder regulator

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Donor-organ/tissue/cell preservation solution

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Donor-organ/tissue/cell preservation solution additive

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Exsanguination set

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lung donor-organ preservation/transport system

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

TurboMed Orthotics Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bed remote control

Manufacturer:

Umano Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Trapeze bar exerciser

Manufacturer:

Umano Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biliary drain

Manufacturer:

UreSil, LLC

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Closed-wound/centesis drainage receptacle

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Luer/Luer linear connector, single-use

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nephrostomy catheter

Manufacturer:

UreSil, LLC

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Pneumothorax catheter insertion set

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction system catheter, general-purpose

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wearable percutaneous catheter/tube holder

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic electric home bed

Manufacturer:

Vermeiren Group

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electric-motor-driven wheelchair, occupant-controlled

Manufacturer:

Vermeiren Group

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

Manufacturer:

Vermeiren Group

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

Versah, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, single-use

Manufacturer:

Versah, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, thermoplastic

Manufacturer:

Vertex-Dental B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Back/leg/chest dynamometer, mechanical

Manufacturer:

Biodex Medical Systems, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile gait rehabilitation system, harness-support

Manufacturer:

Biodex Medical Systems, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posturography system

Manufacturer:

Biodex Medical Systems, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gait-enhancement electrical stimulation system, external

Manufacturer:

Bioness, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

Bioness, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

Bioness, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blue/red/infrared phototherapy lamp

Manufacturer:

BioPhotas, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee support orthosis

Manufacturer:

VQ OrthoCare

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Head-worn lamp

Manufacturer:

Vorotek Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive disk, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive point, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental power tool handpiece motorless component

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diamond dental bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual endodontic file/rasp, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic intraoperative positioning pin, single-use

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pneumatic dental power tool system handpiece tip, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pneumatic dental scaling/debridement system handpiece tip, periodontal, single-use

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotary/reciprocating endodontic file/rasp, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sternum saw blade, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sternum saw blade, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, reciprocating, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, reciprocating, single-use

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, sagittal, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue marking ink

Manufacturer:

GI Supply

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue marking ink

Manufacturer:

GI Supply

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eustachian catheter, single-use

Manufacturer:

Genoss Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gonioscope

Manufacturer:

Ocular Instruments, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laser lens, ophthalmic, surgical

Manufacturer:

Ocular Instruments, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic diagnostic condensing lens

Manufacturer:

Ocular Instruments, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vitrectomy contact lens, single-use

Manufacturer:

Ocular Instruments, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Absorbent underpad, non-antimicrobial, single-use

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incontinence pants liner

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incontinence pants, reusable

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incontinence pants, reusable

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incontinence pants, single-use

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

OSARTIS GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cranioplasty plate screw

Manufacturer:

Osteonic Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

Osteonic Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual orthopaedic bender, reusable

Manufacturer:

Osteonic Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Osteonic Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous administration tubing extension set

Manufacturer:

CAIR LGL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Interspinous spinal fixation implant

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure kit

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental osteotome set

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone-screw internal spinal fixation system, sterile

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arm procedure positioner, reusable

Manufacturer:

OPT SurgiSystems S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hands-free disability-assistive walker

Manufacturer:

Ora Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Femur nail

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Growth-correction orthopaedic fixation plate kit

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Trans-facet-screw internal spinal fixation system, sterile

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone matrix implant, synthetic, non-antimicrobial

Manufacturer:

OSARTIS GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic electrode, single-use

Manufacturer:

Boston Scientific Cardiac Diagnostics Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical networking interface unit

Manufacturer:

Boston Scientific Cardiac Diagnostics Technologies, Inc.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Corneal bur, rust ring removal, single-use

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocautery system generator, battery-powered

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical system generator

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held examination/treatment light

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical electrode, monopolar, reusable

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic instrument surgical connector

Manufacturer:

Bradshaw Medical Inc. (dba Intech)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Diamond dental bur, single-use

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diamond dental bur, single-use

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diamond ENT bur, single-use

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual bone mill

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual non-rotary dental instrument handle

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone trephine, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, single-use

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Craniofacial bone screw, non-bioabsorbable, non-sterile

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive point, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental drill bit extension

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental rongeur

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental soft-tissue coring punch, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental torque wrench

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Membrane fixation tack, non-bioabsorbable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steel dental bur, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical bulldog clamp, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultralow-temperature laboratory freezer

Manufacturer:

Helmer Scientific DBA Helmer Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

HEMODIA SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot-switch, electrical

Manufacturer:

HEMODIA SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot-switch, electrical

Manufacturer:

HEMODIA SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General surgical procedure kit, non-medicated, single-use

Manufacturer:

HEMODIA SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis start/stop set

Manufacturer:

HEMODIA SAS

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Haemodialysis start/stop set

Manufacturer:

HEMODIA SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation tubing set, single-use

Manufacturer:

HEMODIA SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound irrigation kit

Manufacturer:

HEMODIA SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray, reusable

Manufacturer:

Great Lakes Dental Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental matrix band, single-use

Manufacturer:

Greater Curve

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

Precision System Science Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Precision System Science Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rectal/vaginal ultrasound imaging transducer

Manufacturer:

Exact Imaging Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood lancing device tip

Manufacturer:

Facet Technologies, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic manual linear cutting stapler, single-use

Manufacturer:

Ezisurg Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic manual linear cutting stapler, single-use

Manufacturer:

Ezisurg Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic manual linear cutting stapler, single-use

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraluminal circular stapler, single-use

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical staple loading unit, non-cutting

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiograph, home-use

Manufacturer:

Fitbit LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrohydraulic lithotripsy system

Manufacturer:

Northgate Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

High-pressure medical gas hose

Manufacturer:

Northgate Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone matrix implant, synthetic, non-antimicrobial

Manufacturer:

NovaBone Products, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental bone matrix implant, synthetic

Manufacturer:

NovaBone Products, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

NTOC Medische Techniek BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device sterilization/disinfection container, reusable

Manufacturer:

Ocular Instruments, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lung physical simulator

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal oxygen cannula, basic

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nebulizing system delivery set, single-use

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-rebreathing oxygen face mask

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-rebreathing oxygen face mask

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oxygen administration tubing

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rebreathing oxygen face mask

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter introduction needle

Manufacturer:

Galt Medical Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter introduction set, nonimplantable

Manufacturer:

Galt Medical Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter introduction set, nonimplantable

Manufacturer:

Galt Medical Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

Gleamer

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

Gleamer

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Coronary angioplasty balloon catheter, basic

Manufacturer:

Goodman Co., Ltd. Goodman Research Center

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stopcock

Manufacturer:

Goodman Co., Ltd. Goodman Research Center

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Coronary angioplasty balloon catheter, basic

Manufacturer:

Goodman Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Inspiratory/expiratory limb respiratory tubing, single-use

Manufacturer:

Heinz Meise GmbH Medizintechnik

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Hyland Software Canada ULC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

Hyland Software Canada ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone/joint surgical power tool motor, pneumatic

Manufacturer:

IMEDICOM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cranial bur, single-use

Manufacturer:

IMEDICOM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Epidural anaesthesia set, medicated

Manufacturer:

IMEDICOM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible fibreoptic epiduroscope

Manufacturer:

IMEDICOM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurosurgical procedure kit, non-medicated, single-use

Manufacturer:

IMEDICOM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical procedure irrigation fluid

Manufacturer:

Industria Farmaceutica Galenica Senese S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymeric ureteral stent

Manufacturer:

INNOVEX MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible ureteral sheath/fibreoptic telescope

Manufacturer:

INNOVEX MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Secretion suction kit

Manufacturer:

INNOVEX MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electric infusion pump administration set, reusable

Manufacturer:

Jubilant Draximage Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electric infusion pump administration set, single-use

Manufacturer:

Jubilant Draximage Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

Kuraray Noritake Dental Inc. Miyoshi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

Kuraray Noritake Dental Inc. Miyoshi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasound imaging system application software

Manufacturer:

Koios Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone access cannula

Manufacturer:

Lacey Manufacturing Company, LLC / Boston EndoSurgical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Manufacturer:

Lacey Manufacturing Company, LLC / Boston EndoSurgical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel, single-use

Manufacturer:

Lacey Manufacturing Company, LLC / Boston EndoSurgical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral vascular guidewire, manual

Manufacturer:

Lake Region Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral vascular guidewire, manual

Manufacturer:

Lake Region Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral vascular guidewire, manual

Manufacturer:

Lake Region Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation/aspiration tubing set

Manufacturer:

Lagis Enterprise Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac defect occluder

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravascular extraction catheter-snare

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-neurovascular embolization plug, composite

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral angioplasty balloon catheter, basic

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular dilator, single-use

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vena cava filter, temporary/permanent

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Prone scooter board

Manufacturer:

LPG SYSTEMS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Red-light phototherapy unit, professional

Manufacturer:

LumiThera, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological solid-state laser system

Manufacturer:

LUTRONIC Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

Mach7 Technologies Canada Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter/cannula flush solution, anticoagulant, antimicrobial

Manufacturer:

MedXL Inc.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Bronchial balloon catheter

Manufacturer:

Mercator MedSystems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Calcium hydroxide dental cement

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental epoxy resin

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental etching solution

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic paper point

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic temporary cement

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fatty acid dental cement

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Root canal cleaning solution

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Synthetic gutta-percha

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automatic cranial perforator, single-use

Manufacturer:

Micromar Indústria e Comércio Ltda.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

MIM Software Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posturography system

Manufacturer:

Movendo Technology Srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic stereotactic surgery system

Manufacturer:

Navbit Pty Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraocular lens folder

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posterior-chamber intraocular lens, pseudophakic

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posterior-chamber intraocular lens, pseudophakic

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posterior-chamber intraocular lens, pseudophakic

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posterior-chamber intraocular lens, pseudophakic

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hypodermic needle, single-use

Manufacturer:

Needle Concept

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hypodermic needle, single-use

Manufacturer:

Needle Concept

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stereotactic neuronavigation/planning system

Manufacturer:

Nexstim Plc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sequential venous compression system

Manufacturer:

NormaTec Industries, LP

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-gas low pressure tubing, reusable

Manufacturer:

Ohio Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anterior-chamber intraocular lens, phakic

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anterior-chamber intraocular lens, pseudophakic

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Capsular tension ring

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Craniofacial bone screw, non-bioabsorbable

Manufacturer:

Osteogenics Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Craniofacial bone screw, non-bioabsorbable

Manufacturer:

Osteogenics Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical mesh, metal/polymer

Manufacturer:

Osteogenics Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyolefin/fluoropolymer suture, monofilament

Manufacturer:

Osteogenics Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye lubricant

Manufacturer:

Optima Medical Swiss AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held cryosurgical system handpiece tip

Manufacturer:

Pacira Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Paige.AI, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile nucleic acid IVD, control

Manufacturer:

Zeptometrix

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MSSA nucleic acid IVD, control

Manufacturer:

Zeptometrix

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neisseria gonorrhoeae nucleic acid IVD, control

Manufacturer:

Zeptometrix

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neisseria gonorrhoeae nucleic acid IVD, control

Manufacturer:

Zeptometrix

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Zeus Scientific, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunoglobulin removal reagent IVD

Manufacturer:

Zeus Scientific, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

HONG SENG GLOVES SDN. BHD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

HONG SENG GLOVES SDN. BHD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acetabulum prosthesis trial, prefabricated, reusable

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Femoral head prosthesis trial

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic chisel

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic osteotome blade, reusable

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical depth gauge, reusable

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/implant rack

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glucose monitoring system IVD, home-use

Manufacturer:

Bionime Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus antigen IVD, kit, multiplex

Manufacturer:

GenMark Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-genus respiratory virus antigen IVD, kit, multiplex

Manufacturer:

GenMark Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

Manufacturer:

GenMark Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

Manufacturer:

GenMark Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human genomic analysis interpretive software IVD

Manufacturer:

Omixon Biocomputing Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex

Manufacturer:

Zeus Scientific, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Zeus Scientific, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Zeus Scientific, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, control

Manufacturer:

Affinity Biologicals Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Associates of Cape Cod, Incorporated

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Benzodiazepine group IVD, calibrator

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Benzodiazepine group IVD, control

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethyl glucuronide (EtG) IVD, control

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fentanyl IVD, calibrator

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lamotrigine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Levetiracetam therapeutic drug monitoring IVD, calibrator

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Levetiracetam therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple anticonvulsant therapeutic drug monitoring IVD, calibrator

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple anticonvulsant therapeutic drug monitoring IVD, control

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pregabalin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, calibrator

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tramadol IVD, control

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

5-Fluorouracil (5-FU) therapeutic drug monitoring IVD, calibrator

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

5-Fluorouracil (5-FU) therapeutic drug monitoring IVD, reagent

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Busulfan therapeutic drug monitoring IVD, calibrator

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clozapine IVD, reagent

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Imatinib therapeutic drug monitoring IVD, calibrator

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antipsychotic therapeutic drug monitoring IVD, calibrator

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antipsychotic therapeutic drug monitoring IVD, control

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Paclitaxel therapeutic drug monitoring IVD, calibrator

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Quetiapine therapeutic drug monitoring IVD, reagent

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

BRAF V600 gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Biocartis NV

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Biocartis NV

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gas-sampling/monitoring respiratory tubing, single-use

Manufacturer:

Perma Pure LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, single-use

Manufacturer:

phenox GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral vascular guidewire, manual

Manufacturer:

phenox GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

Corning Science Mexico S.A. de C.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Wheelchair tray pressure pad

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone holding forceps

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tap, reusable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical ruler, reusable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant driver

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pin-sleeve orthopaedic bone screw

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, torque-limiting

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Desktop computer

Manufacturer:

ADLINK Technology GmbH,

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Image display unit, colour

Manufacturer:

ADLINK Technology GmbH,

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Image display unit, colour

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge

Manufacturer:

Amann Girrbach AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

Amann Girrbach AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bed pillow, reusable

Manufacturer:

Amenity Health Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medication transfer set

Manufacturer:

West Pharma. Services IL, Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, thermoplastic

Manufacturer:

X-Nav Technologies, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental milling system, CAD/CAM, laboratory

Manufacturer:

X-Nav Technologies, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diagnostic peripheral nerve electrical stimulation system

Manufacturer:

Xavant Technology (Pty) Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transcutaneous electrical stimulation electrode, single-use

Manufacturer:

Xavant Technology (Pty) Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope antifog solution

Manufacturer:

Xodus Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Freestanding patient positioner, single-use

Manufacturer:

Xodus Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table non-slip back pad

Manufacturer:

Xodus Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument interim-placement holder, single-use

Manufacturer:

Xodus Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-ISO80369 formatted bag access spike

Manufacturer:

Yukon Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vial/bottle adaptor, hermetic

Manufacturer:

Yukon Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiopulmonary stress exercise treadmill

Manufacturer:

Full Vision, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adhesive bandage

Manufacturer:

Freudenberg Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heat/moisture exchanger insertable filter

Manufacturer:

Freudenberg Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heat/moisture exchanger/microbial medical gas filter

Manufacturer:

Freudenberg Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostoma shower shield

Manufacturer:

Freudenberg Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy base plate, reusable

Manufacturer:

Freudenberg Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic inter-arch elastic band

Manufacturer:

G and H Wire Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ambulatory non-insulin infusion pump, electronic

Manufacturer:

Ace Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elastomeric infusion pump kit

Manufacturer:

Ace Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous pressure infusor, automated

Manufacturer:

Ace Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Invasive blood pressure transducer set

Manufacturer:

Ace Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient-controlled analgesia electric infusion pump administration set

Manufacturer:

Ace Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Subcutaneous tunneller, single-use

Manufacturer:

Ace Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laser speckle blood flowmeter

Manufacturer:

Activ Surgical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical skin microbial sealant

Manufacturer:

Adhezion Biomedical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Angiography contrast medium injection system, line-powered, mobile

Manufacturer:

Angiodroid SpA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic overtube, single-use

Manufacturer:

Apollo Endosurgery, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haematological concentrate system centrifuge

Manufacturer:

Arteriocyte Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haematological concentrate system preparation kit, bone marrow concentration

Manufacturer:

Arteriocyte Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haematological concentrate/haemostatic agent applicator

Manufacturer:

Arteriocyte Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

Arterys Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Deep-tissue electromagnetic stimulation system, home-use

Manufacturer:

ASA s.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Musculoskeletal/physical therapy laser, home-use

Manufacturer:

ASA s.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thermal-regulation orogastric tube

Manufacturer:

Attune Medical

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Contact lens protein-removal solution

Manufacturer:

AVIZOR S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye lubricant

Manufacturer:

AVIZOR S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose rigid contact lens solution

Manufacturer:

AVIZOR S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose soft contact lens solution

Manufacturer:

AVIZOR S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid contact lens cleaning solution

Manufacturer:

AVIZOR S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft contact lens cleaning solution

Manufacturer:

AVIZOR S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft contact lens cleaning solution

Manufacturer:

AVIZOR S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Angiographic catheter, single-use

Manufacturer:

Balt Extrusion SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Implant radiopacification material

Manufacturer:

Balt Extrusion SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravascular occluding balloon catheter, image-guided

Manufacturer:

Balt Extrusion SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurovascular embolization coil

Manufacturer:

Balt Extrusion SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thrombectomy wire-net

Manufacturer:

Balt Extrusion SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular microcatheter

Manufacturer:

Balt Extrusion SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

Cercare Medical A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Brachytherapy injection needle

Manufacturer:

Best Medical International, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intermittent venous compression system pump

Manufacturer:

Bio Compression Systems, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Single-chamber venous compression system garment, reusable

Manufacturer:

Bio Compression Systems, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone absorptiometric ultrasound system

Manufacturer:

Bone Index Finland Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

Brasseler USA Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical electrode, monopolar, single-use

Manufacturer:

Broncus Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Virtual bronchoscopic navigation PACS software

Manufacturer:

Broncus Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile/portable oxygen concentrator

Manufacturer:

Caire Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Portable liquid oxygen unit

Manufacturer:

Caire Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary liquid oxygen container

Manufacturer:

Caire Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held ultrasound imaging system, body-surface

Manufacturer:

Butterfly Network, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasound imaging system application software

Manufacturer:

Caption Health, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac ablation solid-state laser system

Manufacturer:

CARDIOFOCUS INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemostasis valve

Manufacturer:

CARDIOFOCUS INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastrointestinal endoscopic insufflator

Manufacturer:

Chongqing Jinshan Science& Technology (Group) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manometric gastrointestinal motility analysis system

Manufacturer:

Chongqing Jinshan Science& Technology (Group) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Donor cornea delivery set

Manufacturer:

CorneaGen, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiograph, professional, multichannel

Manufacturer:

Corscience GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General cryosurgical system, cryogen gas, mechanical

Manufacturer:

CryoConcepts, LP

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cosmetic micro-needling electronic handpiece, professional

Manufacturer:

Crown Aesthetics

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound hydrogel dressing, non-antimicrobial

Manufacturer:

Crown Aesthetics

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urethral balloon catheter fill-media

Manufacturer:

D.B.M. S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urinary tract-access lubricant, non-medicated

Manufacturer:

D.B.M. S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial

Manufacturer:

D.B.M. S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial

Manufacturer:

D.B.M. S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oxygen/air breathing gas mixer, hospital

Manufacturer:

DEHAS Medical Systems GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic ultrasound imaging system

Manufacturer:

DGH Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal mucosa protection dressing

Manufacturer:

Dr. August Wolff GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive point, reusable

Manufacturer:

Edenta Establissement

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diamond dental bur, reusable

Manufacturer:

Edenta Establissement

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual endodontic file/rasp, reusable

Manufacturer:

Edenta Establissement

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Podiatric bur, reusable

Manufacturer:

Edenta Establissement

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical networking interface unit

Manufacturer:

Empatica S.r.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple vital physiological parameter monitoring system, home-use

Manufacturer:

Empatica S.r.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing unit, single-use

Manufacturer:

Endo Tools Therapeutics S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Epidural anaesthesia set, non-medicated

Manufacturer:

Epimed International, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Epidural needle, non-threaded

Manufacturer:

Epimed International, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral nerve-block blunt needle access cannula

Manufacturer:

Epimed International, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Analgesic transcutaneous electrical nerve stimulation system

Manufacturer:

Eunsung Global Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bedside syringe pump

Manufacturer:

Eunsung Global Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bedside syringe pump

Manufacturer:

Eunsung Global Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cryolipolysis body contouring system

Manufacturer:

Eunsung Global Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological diode laser system

Manufacturer:

Eunsung Global Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intense pulsed light skin surface treatment system

Manufacturer:

Eunsung Global Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic skin contouring system

Manufacturer:

Eunsung Global Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic skin contouring system

Manufacturer:

Eunsung Global Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Needleless medication/vaccine injector, mechanical

Manufacturer:

European Pharma Group B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone growth ultrasonic stimulator

Manufacturer:

Bioventus LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sensor holder, reusable

Manufacturer:

Bioventus LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sensor holder, single-use

Manufacturer:

Bioventus LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental cement trial

Manufacturer:

Bisco, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental etching solution syringe

Manufacturer:

Bisco, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material mixing surface, chairside, single-use

Manufacturer:

Bisco, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dry skin moisture barrier dressing

Manufacturer:

bitop AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal mucosa dressing, non-antimicrobial

Manufacturer:

bitop AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal mucosa protection dressing

Manufacturer:

bitop AG

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Biofeedback system application software

Manufacturer:

Bittium Biosignals Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electroencephalographic ambulatory recorder

Manufacturer:

Bittium Biosignals Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Telemetric electrocardiographic ambulatory recorder

Manufacturer:

Bittium Biosignals Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liposuction system cannula, single-use

Manufacturer:

Black Tie Medical Inc. DBA Tulip Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

X-ray image interpretive software

Manufacturer:

Precision Medical Ventures Inc. dba RevealDx

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral angioplasty balloon catheter, basic

Manufacturer:

Qualimed Innovative Medizinprodukte GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral artery stent, bare-metal

Manufacturer:

Qualimed Innovative Medizinprodukte GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous administration tubing extension set

Manufacturer:

Quest Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgical procedure kit, non-medicated, single-use

Manufacturer:

Quest Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical support tape, non-bioabsorbable

Manufacturer:

Quest Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical support tape, non-bioabsorbable

Manufacturer:

Quest Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone access cannula

Manufacturer:

Ranfac Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, single-use

Manufacturer:

REMINGTON MEDICAL INC

Type:

Active Implantable Device

Registration Date:

Nov 26, 2024

Autoinjector needle

Manufacturer:

Sandstone Medical (Suzhou) Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video bronchoscope, single-use

Manufacturer:

Shanghai Anqing Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video choledochoscope, single-use

Manufacturer:

Shanghai Anqing Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video ureterorenoscope, single-use

Manufacturer:

Shanghai Anqing Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Balloon kyphoplasty kit

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood cell harvesting system

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone marrow collection/transfusion set

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Bone marrow collection/transfusion set

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone trephine tubing set

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical electrode, bipolar, single-use

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Epidural anaesthesia set, non-medicated

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Epidural anaesthesia set, non-medicated

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Epidural anaesthesia set, non-medicated

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Epidural anaesthesia set, non-medicated

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haematological concentrate system preparation kit, bone marrow concentration

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement, non-antimicrobial

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radio-frequency skin surface treatment system

Manufacturer:

SHENB Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

Manufacturer:

Bolder Surgical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

Manufacturer:

Bolder Surgical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Linear accelerator system

Manufacturer:

Accuray Incorporated

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External orthopaedic fixation system, single-use, sterile

Manufacturer:

AREX

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal duodenal stent

Manufacturer:

BCM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasound pachymeter

Manufacturer:

DGH Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

DICOM Grid Inc. d/b/a Ambra Health

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General/multiple surgical laser system beam guide, single-use

Manufacturer:

Dornier MedTech America, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal mucosa protection dressing

Manufacturer:

Dr. August Wolff GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal pH suppository

Manufacturer:

Dr. August Wolff GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac electrophysiology processing software

Manufacturer:

Eko Health, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electronic stethoscope

Manufacturer:

Eko Health, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental restoration retention pin

Manufacturer:

Edenta Establissement

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic overtube, single-use

Manufacturer:

Endo Tools Therapeutics S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing unit, single-use

Manufacturer:

Endo Tools Therapeutics S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing unit, single-use

Manufacturer:

Endogastric Solutions

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous radio-frequency ablation probe cannula, single-use

Manufacturer:

Epimed International, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral nerve-block blunt needle

Manufacturer:

Epimed International, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic manual linear cutting stapler, single-use

Manufacturer:

Ezisurg Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic motorized cutting stapler, single-use

Manufacturer:

Ezisurg Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemorrhoidal surgical stapler, single-use

Manufacturer:

Ezisurg Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery manual linear cutting stapler, single-use

Manufacturer:

Ezisurg Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery manual linear cutting stapler, single-use

Manufacturer:

Ezisurg Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft-tissue ultrasonic surgical system

Manufacturer:

Ezisurg Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laparoscopic access cannula, single-use

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

FEops NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiograph, home-use

Manufacturer:

Fitbit LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, skin

Manufacturer:

Fitbit LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ambulatory syringe pump

Manufacturer:

Phillips Medisize A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastro-urological guidewire, single-use

Manufacturer:

PIOLAX MEDICAL DEVICES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical system

Manufacturer:

Pulse Biosciences, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thrombectomy suction catheter

Manufacturer:

Qualimed Innovative Medizinprodukte GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular guide-catheter, single-use

Manufacturer:

Qualimed Innovative Medizinprodukte GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI system coil, radio-frequency

Manufacturer:

Quality Electrodynamics, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI system coil, radio-frequency

Manufacturer:

Quality Electrodynamics, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Aorta punch, single-use

Manufacturer:

Quest Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardioplegia solution administration adaptor

Manufacturer:

Quest Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiopulmonary bypass system heat exchanger, reusable

Manufacturer:

Quest Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiopulmonary bypass system heat exchanger, reusable

Manufacturer:

Quest Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiopulmonary bypass system valve, unidirectional flow/pressure control

Manufacturer:

Quest Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, single-use

Manufacturer:

REMINGTON MEDICAL INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

End-cut biopsy gun needle

Manufacturer:

REMINGTON MEDICAL INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastric band

Manufacturer:

ReShape Lifesciences

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastric calibration tube

Manufacturer:

ReShape Lifesciences

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Subcutaneous infusion/injection port needle

Manufacturer:

ReShape Lifesciences

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bench-top keratometer

Manufacturer:

SANTEC OIS CORPORATION

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Apheresis system tubing set

Manufacturer:

SASAN SAGLIK MALZEMELERI URETIM VE PAZARLAMA A.S.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endomyocardial biopsy forceps, single-use

Manufacturer:

Scholten Surgical Instruments, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic video image processing unit

Manufacturer:

Shanghai Anqing Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic video image processing unit

Manufacturer:

Shanghai Anqing Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video cystoscope, single-use

Manufacturer:

Shanghai Anqing Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravascular occluding funnel catheter

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lumbar decompression procedure kit

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radio-frequency skin surface treatment system

Manufacturer:

SHENB Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Linear accelerator system

Manufacturer:

Accuray Incorporated

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Linear accelerator system

Manufacturer:

Accuray Incorporated

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiation therapy treatment planning workstation

Manufacturer:

Accuray Incorporated

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tendon spacer

Manufacturer:

AREX

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal colonic stent

Manufacturer:

BCM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal duodenal stent

Manufacturer:

BCM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal biliary stent, non-bioabsorbable

Manufacturer:

BCM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

In vitro ionizing-radiation blood irradiator

Manufacturer:

Best Theratronics

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Teletherapy radionuclide system, conventional

Manufacturer:

Best Theratronics

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic manual linear cutting stapler, single-use

Manufacturer:

Bolder Surgical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical staple loading unit, non-cutting

Manufacturer:

Bolder Surgical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Coronary optical coherence tomography system

Manufacturer:

Gentuity, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood/tissue storage/culture container

Manufacturer:

Hemanext Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological carbon dioxide laser system

Manufacturer:

Jeisys Medical Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological frequency-doubled solid-state laser system

Manufacturer:

Jeisys Medical Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation system nozzle

Manufacturer:

Medaxis AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation system nozzle

Manufacturer:

Medaxis AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation system nozzle

Manufacturer:

Medaxis AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/orthopaedic lavage control unit

Manufacturer:

Medaxis AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal biliary stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal biliary stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal duodenal stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal oesophageal stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal oesophageal stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal biliary stent, non-bioabsorbable

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal biliary stent, non-bioabsorbable

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal colonic stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal oesophageal stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal oesophageal stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electroencephalograph

Manufacturer:

Micromed SpA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient monitoring system module, electroencephalographic

Manufacturer:

Micromed SpA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic knife, single-use

Manufacturer:

New World Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cerebral oximeter sensor, single-use

Manufacturer:

Nonin Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulse oximeter probe, single-use

Manufacturer:

Nonin Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulse oximeter probe/processor

Manufacturer:

Nonin Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic male condom, Hevea-latex

Manufacturer:

Okamoto Industries, Inc. Ibaraki Plant

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical tip cleaning pad

Manufacturer:

Olsen Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Manufacturer:

Olsen Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal urethral stent, long-term

Manufacturer:

PNN Medical A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scar management dressing, reusable

Manufacturer:

Bio Med Sciences, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound-nonadherent dressing, absorbent, non-antimicrobial

Manufacturer:

Bio Med Sciences, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Histology/cytology/microbiology image-analysis interpretive software IVD

Manufacturer:

Indica Labs

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Menstrual cycle self-monitoring software

Manufacturer:

NaturalCycles Nordic AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Self-care monitoring/reporting software

Manufacturer:

NaturalCycles Nordic AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic video image interpretive software

Manufacturer:

NEC Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic video image interpretive software

Manufacturer:

NEC Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI system coil, radio-frequency

Manufacturer:

NeoCoil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI-oriented needle guide positioner

Manufacturer:

NeoCoil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology picture archiving and communication system digital archive device

Manufacturer:

NeoSoft LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, reusable

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis/implant abutment screw analog, single-use

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental torque wrench

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Airway suction catheter

Manufacturer:

Neotech Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breast pump support kit, reusable

Manufacturer:

Neotech Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endotracheal tube holder

Manufacturer:

Neotech Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal oxygen cannula, basic

Manufacturer:

Neotech Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube neck holder, single-use

Manufacturer:

Neotech Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Analytical scalp electrode, reusable

Manufacturer:

Neuroelectrics Barcelona S.L.U

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Analytical scalp electrode, reusable

Manufacturer:

Neuroelectrics Barcelona S.L.U

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electroencephalographic monitoring system

Manufacturer:

Neuroelectrics Barcelona S.L.U

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transcutaneous electrical stimulation electrode, reusable

Manufacturer:

Neuroelectrics Barcelona S.L.U

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pupillometer, electrically-powered

Manufacturer:

NeurOptics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose bowl, single-use

Manufacturer:

NewGen Surgical INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin stapler/staple, non-bioabsorbable

Manufacturer:

NewGen Surgical INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adhesive bandage

Manufacturer:

NICHIBAN CO.,LTD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adhesive bandage

Manufacturer:

NICHIBAN CO.,LTD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical handpiece/electrode holder, single-use

Manufacturer:

ITL Asia Pacific Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sharp surgical instrument counting tray/pad, single-use

Manufacturer:

ITL Asia Pacific Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

Lab Kinetics LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electrosurgical return electrode, single-use

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical tip cleaning pad

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External defibrillation electrode, paediatric, single-use

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment handle cover, single-use

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin topical coupling gel

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Topical coupling gel, sterile

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vein stripper, single-use

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Examination/treatment table, manual

Manufacturer:

The Brewer Company LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pressure bandage, non-latex, reusable

Manufacturer:

The Marena Group, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spectacle frame

Manufacturer:

Thelios S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Psychophysiological biofeedback system

Manufacturer:

Thought Technology Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasogastric tube holder, noninvasive

Manufacturer:

TIDI Product, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urinary catheter holder

Manufacturer:

TIDI Product, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urinary incontinence penis sheath/port, single-use

Manufacturer:

TIDI Product, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental coating, tooth-desensitizing, professional

Manufacturer:

Tokuyama Dental Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

Tokuyama Dental Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentine bonding agent/set

Manufacturer:

Tokuyama Dental Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Denture reliner, elastic, long-term

Manufacturer:

Tokuyama Dental Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneal topography system

Manufacturer:

Tracey Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Donor-organ preservation/transport perfusion set connection kit

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Donor-organ preservation/transport perfusion set vessel tie tool

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Donor-organ preservation/transport system gas refillable cylinder

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Donor-organ/tissue/cell preservation solution

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Donor-organ/tissue/cell preservation solution

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical mains power cable

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Exsanguination set

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Portable/mobile rechargeable battery pack

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

TRI Dental Implants Int. AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

TRI Dental Implants Int. AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

TRI Dental Implants Int. AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

TurboMed Orthotics Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic electric hospital bed

Manufacturer:

Umano Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bedside monitor remote-viewing software, non-physiological parameter

Manufacturer:

Umano Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transportable medical equipment stand, non-powered

Manufacturer:

Umano Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biliary drain

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound/centesis drainage receptacle

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound/centesis drainage receptacle

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nephrostomy catheter

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nephrostomy catheter

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pneumothorax catheter insertion set

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pneumothorax catheter insertion set

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pneumothorax catheter insertion set

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wearable percutaneous catheter/tube holder

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, single-use

Manufacturer:

Versah, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

Vertex-Dental B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

Vertex-Dental B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis veneer resin

Manufacturer:

Vertex-Dental B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posturography system

Manufacturer:

Biodex Medical Systems, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Standard treadmill, powered

Manufacturer:

Biodex Medical Systems, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Standard treadmill, powered

Manufacturer:

Biodex Medical Systems, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

Bioness, Inc.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Blue/red/infrared phototherapy lamp

Manufacturer:

BioPhotas, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blue/red/infrared phototherapy lamp

Manufacturer:

BioPhotas, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body-surface pressure mapping system

Manufacturer:

Vista Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical binoculars, reusable

Manufacturer:

Vorotek Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Portable active medical device mount

Manufacturer:

Walk Vascular, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation/aspiration tubing set

Manufacturer:

Walk Vascular, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrode conductive medium

Manufacturer:

Weaver and Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infant hip harness

Manufacturer:

Wheaton Brace Co

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ceramic dental bur

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone file/rasp, reciprocating, single-use

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cranial bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental mandrel

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diamond dental bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic broach, serrated, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic enlarger, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic enlarger, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bur, single-use

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bur, single-use

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic intraoperative positioning pin, single-use

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pin/post dental drill bit

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pneumatic dental power tool system handpiece tip, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Root canal post, preformed

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Root canal post, preformed

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotary/reciprocating endodontic file/rasp, single-use

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steel dental bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steel dental bur, single-use

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilizer/disinfector rack instrument-holding insert, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, reciprocating, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, sagittal, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, sagittal, single-use

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic bite block, basic, single-use

Manufacturer:

GI Supply

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Submucosal lift solution/gel

Manufacturer:

GI Supply

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermal tissue reconstructive material, microbe-derived

Manufacturer:

Genoss Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgical device handling forceps

Manufacturer:

Ocular Instruments, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adult nappy

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adult nappy

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incontinence pants liner

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incontinence pants liner

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incontinence pants, reusable

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Universal operating table top

Manufacturer:

OPT SurgiSystems S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External orthopaedic fixation system, reusable

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, reusable

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement, antimicrobial

Manufacturer:

OSARTIS GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Internal spinal fixation system cable cutter

Manufacturer:

Bradshaw Medical Inc. (dba Intech)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic rod reducer

Manufacturer:

Bradshaw Medical Inc. (dba Intech)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocautery system handpiece

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrooculograph electrode

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical return electrode, reusable

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot-switch, electrical

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nerve-locating system

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical plume evacuation system

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material application tool, reusable

Manufacturer:

Sun Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sleep disorder interpretive software, professional-only

Manufacturer:

Sunrise SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sleep disorder interpretive software, professional-only

Manufacturer:

Sunrise SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Rex Implants

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Rex Implants

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

Rex Implants

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Rex Implants

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Rex Implants

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical mallet

Manufacturer:

Rex Implants

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Rex Implants

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Catheter orifice occluder

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound drain connector

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastrostomy tube

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical ruler, reusable

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasogastric feeding tube

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

PEEP valve, reusable

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rebreathing oxygen face mask

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Single-administration urethral drainage/irrigation catheter

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction/irrigation tubing, single-use

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sump drain

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incontinence pants, reusable

Manufacturer:

FRA PRODUCTION SPA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acupressure wristband

Manufacturer:

Fridababy, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flatus tube, single-use

Manufacturer:

Fridababy, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Home-use transdermal medication applicator

Manufacturer:

Fridababy, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hot/cold therapy pack, reusable

Manufacturer:

Fridababy, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Amputation knife

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone awl, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone nail guidewire, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone nail guidewire, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone nail guidewire, single-use

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cannulated surgical drill bit, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cannulated surgical drill bit, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cannulated surgical drill bit, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cannulated surgical drill bit, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip internal fixation system

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual wire driver

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant aiming/guiding block, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant driver

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant driver

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical countersink, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical depth gauge, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant template, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant/trial-implant/sizer holder, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant/trial-implant/sizer holder, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical mallet

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical power tool adaptor

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneal scissors, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical electrode, monopolar, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose surgical spatula

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laparoscopic surgery handle

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngeal knife

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual surgical rotary handpiece, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual surgical saw blade, flexible, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mouth gag, adjustable, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rectal speculum

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rib spreader, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilization stringer

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical bulldog clamp, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical flat-nosed pliers

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical gouge

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical retractor/retraction system blade, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical soft-tissue manipulation forceps, alligator, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suture knot pusher, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suture scissors

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tendon stripper

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tympanotomy knife, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urethral dilator, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular dilator, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular scissors

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vein stripper, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wire holding/twisting pliers

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal colonic stent

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal oesophageal stent

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastro-urological guidewire, single-use

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrohydraulic lithotripsy system

Manufacturer:

Northgate Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material injection cannula, reusable

Manufacturer:

NovaBone Products, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General oral wound dressing, animal-derived

Manufacturer:

NovaBone Products, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device sterilization/disinfection container, reusable

Manufacturer:

NTOC Medische Techniek BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye training model

Manufacturer:

Ocular Instruments, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flieringa ophthalmic ring

Manufacturer:

Ocular Instruments, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lung physical simulator

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal oxygen cannula, CPAP

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ventilator breathing circuit, single-use

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemostasis valve

Manufacturer:

Galt Medical Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral vascular guidewire, manual

Manufacturer:

Galt Medical Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular dilator, single-use

Manufacturer:

Galt Medical Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone-screw internal spinal fixation system, sterile

Manufacturer:

GetSet Surgical SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Internal spinal fixation procedure kit, single-use

Manufacturer:

GetSet Surgical SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stopcock

Manufacturer:

Goodman Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Epicardial pacing lead

Manufacturer:

Greatbatch Ltd. d/b/a Greatbatch Medical

Type:

Active Implantable Device

Registration Date:

Nov 26, 2024

Vascular catheter introduction set, nonimplantable

Manufacturer:

Greatbatch Ltd. d/b/a Greatbatch Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic archwire/bracket ligature

Manufacturer:

Highland Metals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic spring

Manufacturer:

Highland Metals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

X-ray image interpretive software

Manufacturer:

Imbio, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Balloon kyphoplasty kit

Manufacturer:

IMEDICOM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Balloon kyphoplasty kit

Manufacturer:

IMEDICOM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Epidural/intrathecal anaesthesia set, non-medicated

Manufacturer:

IMEDICOM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose surgical power tool system, rechargeable battery-powered

Manufacturer:

IMEDICOM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, oscillating, single-use

Manufacturer:

IMEDICOM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, reciprocating, single-use

Manufacturer:

IMEDICOM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical procedure irrigation fluid

Manufacturer:

Industria Farmaceutica Galenica Senese S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hygroscopic dental cement

Manufacturer:

Innovative BioCeramix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biliary/urinary stone retrieval basket, single-use

Manufacturer:

INNOVEX MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endobronchial occluder

Manufacturer:

INNOVEX MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible ureteral sheath/fibreoptic telescope

Manufacturer:

INNOVEX MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymeric ureteral stent

Manufacturer:

INNOVEX MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oesophageal endoscopic ligator, single-use

Manufacturer:

Intelligent Endoscopy LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External haemorrhage clamp

Manufacturer:

Innovative Trauma Care Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

INVIA, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

Kuraray Noritake Dental Inc. Miyoshi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasound imaging system application software

Manufacturer:

Koios Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone access cannula

Manufacturer:

Lacey Manufacturing Company, LLC / Boston EndoSurgical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

Manufacturer:

Lacey Manufacturing Company, LLC / Boston EndoSurgical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel, single-use

Manufacturer:

Lacey Manufacturing Company, LLC / Boston EndoSurgical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac/peripheral vascular guidewire, single-use

Manufacturer:

Lake Region Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac/peripheral vascular guidewire, single-use

Manufacturer:

Lake Region Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laparoscopic access cannula, single-use

Manufacturer:

Lagis Enterprise Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laparoscopic access cannula, single-use

Manufacturer:

Lagis Enterprise Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laparoscopic access cannula, single-use

Manufacturer:

Lagis Enterprise Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radial surgical retractor

Manufacturer:

Lagis Enterprise Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation pump

Manufacturer:

Lagis Enterprise Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Musculoskeletal/physical therapy laser, professional

Manufacturer:

LiteCure, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Aortic stent implantation kit

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac occluder delivery kit

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral vascular guidewire, manual

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral vascular guidewire, manual

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter introduction set, nonimplantable

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Freestanding electric massager

Manufacturer:

LPG SYSTEMS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological carbon dioxide laser system

Manufacturer:

LUTRONIC Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radio-frequency skin surface treatment system

Manufacturer:

LUTRONIC Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Red-light phototherapy unit, professional

Manufacturer:

LUTRONIC Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Donor-organ/tissue/cell preservation solution

Manufacturer:

Marizyme Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgical instrument handle, pneumatic

Manufacturer:

Medical Instrument Development Laboratories, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter/cannula flush solution, anticoagulant, antimicrobial

Manufacturer:

MedXL Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatoscope, optical

Manufacturer:

MedX Health Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Coronary artery infusion catheter

Manufacturer:

Mercator MedSystems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentine bonding agent/set

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posturography system

Manufacturer:

Movendo Technology Srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Syringe-loaded medication/vaccine injector, electropneumatic

Manufacturer:

Needle Concept

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Antimicrobial wound irrigation solution

Manufacturer:

Next Science LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgical probe, single-use

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posterior-chamber intraocular lens, pseudophakic

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posterior-chamber intraocular lens, pseudophakic

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Collagen dental regeneration membrane

Manufacturer:

Osteogenics Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pliable-polymer dental regeneration membrane, non-bioabsorbable

Manufacturer:

Osteogenics Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eyelid solution

Manufacturer:

Optima Medical Swiss AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrous oxide gas cartridge

Manufacturer:

Pacira Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General specimen container IVD, additive/medium

Manufacturer:

Novosanis NV

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

Novosanis NV

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Eye lubricant

Manufacturer:

bitop AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Histology/cytology/microbiology image-analysis interpretive software IVD

Manufacturer:

Paige.AI, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Paige.AI, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Paige.AI, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bone growth ultrasonic stimulator

Manufacturer:

Bioventus LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone growth ultrasonic stimulator

Manufacturer:

Bioventus LLC

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Personal device holder, single-use

Manufacturer:

Bioventus LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiographic image marker, manual

Manufacturer:

Bioventus LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological image marker, noninvasive, single-use

Manufacturer:

Bioventus LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Synovial fluid supplementation medium

Manufacturer:

Bioventus LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material application tool, single-use

Manufacturer:

Bisco, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material injection cannula, single-use

Manufacturer:

Bisco, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material mixing nozzle

Manufacturer:

Bisco, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis priming agent

Manufacturer:

Bisco, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental restoration fixation cleaning solution

Manufacturer:

Bisco, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentine bonding agent/set

Manufacturer:

Bisco, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal mucosa protection dressing

Manufacturer:

bitop AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Analytical scalp electrode, single-use

Manufacturer:

Bittium Biosignals Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac electrophysiology processing software

Manufacturer:

Bittium Biosignals Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic electrode, single-use

Manufacturer:

Bittium Biosignals Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Aneurysm clip

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Head/neck procedure positioner

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Leg procedure positioner

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical table clamp

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurosurgical headrest

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skull clamp

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Universal operating table, hydraulic

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urological fluid funnel, non-sterile

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose absorbent tip applicator/swab, single-use

Manufacturer:

MML Diagnostics Packaging, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anaesthesia screen

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bed pillow, reusable

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Femur lifter, electric

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Footrest

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Head/neck procedure positioner

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heel protector

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Leg/knee cushion

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Limb/torso/head restraint, reusable

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment drape, single-use

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating room equipment remote control

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table handcrank

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table mattress, basic

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table patient pressure distribution pad, single-use

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table torso positioner

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient transfer sliding mat

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scoliometer

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoulder immobilizer/orthosis, single-use

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical counter-traction post

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical traction tensioner

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical traction tensioner connector

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Traction system spreader bar

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tongue-retaining sleep-disordered breathing orthosis

Manufacturer:

MPowrx Health and Wellness Products 2012 Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acetabular orthopaedic reamer

Manufacturer:

MPS Micro Precision Systems AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone nail guidewire, reusable

Manufacturer:

MPS Micro Precision Systems AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

MPS Micro Precision Systems AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body-powered hand prosthesis

Manufacturer:

Naked Prosthetics

Type:

General Medical Device

Registration Date:

Nov 26, 2024

First aid limb splint, mouldable, reusable

Manufacturer:

SAM Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pneumothorax dressing

Manufacturer:

SAM Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scar management dressing, reusable

Manufacturer:

Scar Heal

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, thermoplastic

Manufacturer:

SCHEU-DENTAL GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray, single-use

Manufacturer:

SCHEU-DENTAL GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope working-channel seal

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laparoscopic access cannula, reusable

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laparoscopic access cannula, reusable

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Low-pressure tubing connector, reusable

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid endoscope obturator

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid optical arthroscope, reusable

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid optical laparoscope

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid optical sinoscope

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression material adhesive

Manufacturer:

Schottlander Manufacturing GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental restorative material varnish

Manufacturer:

Schottlander Manufacturing GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gingival retraction solution

Manufacturer:

Schottlander Manufacturing GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge

Manufacturer:

Schottlander Manufacturing GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid optical ureterorenoscope

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid video laparoscope

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General examination/treatment chair, manual

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Head/neck procedure positioner

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table torso positioner

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical distractor, external

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal surgery positioning board

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental drill bit extension

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental osteotome

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual surgical rotary handpiece, reusable

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone-screw internal spinal fixation system, non-sterile

Manufacturer:

SIGNUS Medizintechnick GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone-screw internal spinal fixation system, sterile

Manufacturer:

SIGNUS Medizintechnick GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone wire

Manufacturer:

SIGNUS Medizintechnick GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sacroiliac joint intra-articular arthrodesis implant

Manufacturer:

SIGNUS Medizintechnick GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vertebral body prosthesis

Manufacturer:

SIGNUS Medizintechnick GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dry skin moisture barrier dressing

Manufacturer:

Sion Biotext Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-body orifice lubricant

Manufacturer:

Sion Biotext Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-body orifice lubricant, non-sterile

Manufacturer:

Sion Biotext Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose surgical sponge

Manufacturer:

Sion Biotext Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment handle cover, single-use

Manufacturer:

Sion Biotext Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment handle cover, single-use, non-sterile

Manufacturer:

Sion Biotext Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-woven gauze pad

Manufacturer:

Sion Biotext Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiopaque non-woven surgical sponge

Manufacturer:

Sion Biotext Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiopaque woven surgical sponge

Manufacturer:

Sion Biotext Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Implantable orthopaedic fixation device connection screw

Manufacturer:

Skeletal Dynamics, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Skeletal Dynamics, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mucin IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple breast tissue/tumour marker IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid hybridization detection IVD, reagent

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Paired box protein (PAX) IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Polyvalent human immunoglobulin antibody IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sal-like protein 4 (SALL4) IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Specimen preparation enzyme reagent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptavidin-enzyme conjugate reagent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Terminal deoxynucleotidyl transferase (TdT) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tumour necrosis factor receptor superfamily IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vimentin IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Zeta chain associated protein kinase 70 (ZAP-70) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electrosurgical return electrode, single-use

Manufacturer:

DIROS TECHNOLOGY INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nerve-locating anaesthesia needle

Manufacturer:

DIROS TECHNOLOGY INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous radio-frequency ablation probe cannula, single-use

Manufacturer:

DIROS TECHNOLOGY INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable

Manufacturer:

DIROS TECHNOLOGY INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral nerve-block sharp needle

Manufacturer:

DIROS TECHNOLOGY INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye splash shield, single-use

Manufacturer:

Dupaco Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid contact lens inserter/remover

Manufacturer:

DMV Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electromechanical lithotripsy system, extracorporeal

Manufacturer:

Dornier MedTech GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixed examination/treatment room light

Manufacturer:

Dr. Mach GmbH & Co KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray material

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material mixing nozzle

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental restorative material varnish

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Denture reliner, soft, professional

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental delivery system irrigation handpiece

Manufacturer:

Inter-Med, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material application tool, single-use

Manufacturer:

Inter-Med, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material heater

Manufacturer:

Inter-Med, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material injection cannula, single-use

Manufacturer:

Inter-Med, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/surgical polymerization lamp

Manufacturer:

Inter-Med, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/surgical polymerization lamp

Manufacturer:

Inter-Med, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hydrophobic Luer filter

Manufacturer:

International Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Luer-formatted protective cap

Manufacturer:

International Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical suction system collection container, single-use

Manufacturer:

INTERSCOPE, INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Custom-made dental crown, polymer

Manufacturer:

EnvisionTEC GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental guided surgery reference plate

Manufacturer:

EnvisionTEC GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diagnostic x-ray system chair

Manufacturer:

EOS imaging

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Invasive breast implant sizer, fixed, single-use

Manufacturer:

Establishment Labs S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Invasive breast implant sizer, inflatable

Manufacturer:

Establishment Labs S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Silicone gel-filled breast implant, smooth-surface

Manufacturer:

Establishment Labs S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Silicone gel-filled breast implant, textured-surface

Manufacturer:

Establishment Labs S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-port tissue expander

Manufacturer:

Establishment Labs S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-port tissue expander

Manufacturer:

Establishment Labs S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue expander injection port locator

Manufacturer:

Establishment Labs S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical mallet

Manufacturer:

Etablissements OURY-GUYE et Fils

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing needle holder, reusable

Manufacturer:

Lincotek Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing needle holder, reusable

Manufacturer:

Lincotek Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operative-site suture holder

Manufacturer:

LSI SOLUTIONS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical retractor/retraction system blade, reusable

Manufacturer:

LSI SOLUTIONS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suture clasp, non-bioabsorbable

Manufacturer:

LSI SOLUTIONS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suture clasp, non-bioabsorbable

Manufacturer:

LSI SOLUTIONS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing unit, single-use

Manufacturer:

LSI SOLUTIONS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/endoscope cleaning utensil, reusable

Manufacturer:

Marketlab Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous pole

Manufacturer:

Maxtec, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oxygen/air breathing gas mixer, hospital

Manufacturer:

Maxtec, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Respiratory oxygen monitor, line-powered

Manufacturer:

Maxtec, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive air jet system handpiece

Manufacturer:

Mectron S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic dental scaling/debridement system

Manufacturer:

Mectron S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Capillary blood collection tube IVD, K2EDTA

Manufacturer:

Drucker Diagnostics, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Orthopaedic/craniofacial implantation planning software

Manufacturer:

mediCAD Hectec GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Aerosol face mask, rebreathing, single-use

Manufacturer:

Medical Developments International Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medicine chamber spacer, reusable

Manufacturer:

Medical Developments International Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medicine chamber spacer, reusable

Manufacturer:

Medical Developments International Limited

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Single-administration urethral catheterization kit, single-use

Manufacturer:

Medical Technologies of Georgia. Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant/teeth debridement brush, biodegradable

Manufacturer:

B&L Biotech, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material application tool, reusable

Manufacturer:

B&L Biotech, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental mirror, reusable

Manufacturer:

B&L Biotech, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual dental scaler, reusable

Manufacturer:

B&L Biotech, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual non-rotary dental instrument handle

Manufacturer:

B&L Biotech, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Periosteal elevator, reusable

Manufacturer:

B&L Biotech, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurovascular embolization coil

Manufacturer:

Balt USA, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular implant detacher, electronic, single-use

Manufacturer:

Balt USA, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cavity-wound management dressing, non-antimicrobial

Manufacturer:

Ferris Mfg. Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound-nonadherent dressing, absorbent, non-antimicrobial

Manufacturer:

Ferris Mfg. Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Depth electrode

Manufacturer:

FHC, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intracerebral cannula, nonimplantable, single-use

Manufacturer:

FHC, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurological stereotactic surgery system

Manufacturer:

FHC, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurological stereotactic surgery system

Manufacturer:

FHC, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurological stereotactic surgery system

Manufacturer:

FHC, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

Fillauer Europe AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Passive elbow prosthesis, locking

Manufacturer:

Fillauer Europe AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic enlarger, reusable

Manufacturer:

FKG Dentaire Sàrl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic obturation material distribution endpiece, reusable

Manufacturer:

FKG Dentaire Sàrl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic plugger

Manufacturer:

FKG Dentaire Sàrl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic stopper

Manufacturer:

FKG Dentaire Sàrl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic obturation material distribution endpiece, reusable

Manufacturer:

FKG Dentaire SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic plugger

Manufacturer:

FKG Dentaire SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotary/reciprocating endodontic file/rasp, reusable

Manufacturer:

FKG Dentaire SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic appliance relief material

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic archwire

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket, metal

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic extraoral headgear

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic inter-arch elastic band

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic inter-bracket elastic chain

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic separator

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microscopy mounting medium IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nerve growth factor receptor p75 IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Basic diagnostic x-ray system application software

Manufacturer:

JPI Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary basic diagnostic x-ray system, digital

Manufacturer:

JPI Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

KCL GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous access site infiltration/extravasation monitoring system transceiver

Manufacturer:

ivWatch, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adhesive bandage

Manufacturer:

Kinesio Holding Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose light source

Manufacturer:

Riverpoint Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyester suture, bioabsorbable, multifilament, non-antimicrobial

Manufacturer:

Riverpoint Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyester suture, non-bioabsorbable, multifilament

Manufacturer:

Riverpoint Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyolefin/fluoropolymer suture, monofilament

Manufacturer:

Riverpoint Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological image marker, implantable

Manufacturer:

Riverpoint Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tendon/ligament bone anchor, non-bioabsorbable

Manufacturer:

Riverpoint Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table orthopaedic extension

Manufacturer:

Kyra Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table torso positioner

Manufacturer:

Kyra Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental coating, tooth-desensitizing, professional

Manufacturer:

Kuraray Noritake Dental Inc. Kurashiki

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

Kuraray Noritake Dental Inc. Kurashiki

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental etching solution

Manufacturer:

Kuraray Noritake Dental Inc. Kurashiki

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material application tool, single-use

Manufacturer:

Kuraray Noritake Dental Inc. Kurashiki

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentine bonding agent/set

Manufacturer:

Kuraray Noritake Dental Inc. Kurashiki

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General external orthopaedic fixation system implantation kit, reusable

Manufacturer:

Laboratoires Bodycad, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General surgical procedure kit, non-medicated, reusable

Manufacturer:

Laboratoires Bodycad, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow/wrist/hand orthosis

Manufacturer:

Lenjoy Medical Engineering, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic intravenous administration set, noninvasive

Manufacturer:

Leventon, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elastomeric infusion pump system

Manufacturer:

Leventon, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adenovirus immunoglobulin G (IgG) antibody IVD, reagent

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha thalassemia/mental retardation syndrome X-linked (ATRX) IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amyloid A component IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B lymphocyte IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-cell specific activator protein (BSAP) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bcl-2 oncoprotein IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bcl-6 protein IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-catenin IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Biological stain IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

BRAF V600 gene mutation IVD, reagent

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered isotonic saline reagent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calretinin protein IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD10 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD103 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD117 (c-kit) cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD138 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD15 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD19 cell marker IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD1a cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD4 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD43 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD44 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD45 leukocyte common antigen cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD45RO cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD57 natural killer cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD79a cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chromogranin A IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor XIIIa pro-enzyme subunit IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dewaxing solution IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dewaxing solution IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

E-cadherin epithelial marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epithelial antigen IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) antigen IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Folate receptor alpha (FRa) IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Follicle stimulating hormone (FSH) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

GATA protein transcription factor IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose transporter (GLUT) protein IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glypican-3 IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gross cystic disease fluid protein-15 IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HLA class II antigen identification IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry protease reagent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human papillomavirus (HPV) antigen IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human placental alkaline phosphatase (hPLAP) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry antibody detection IVD, reagent

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry antibody diluent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry conjugated secondary antibody IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry endogenous enzyme blocking reagent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry negative control (normal animal serum) IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Isocitrate dehydrogenase 1 (IDH1) IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Melan-A/MART-1 peptide IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mesothelin IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide maker/stainer IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide stainer IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Aldosterone IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Corticosterone IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepcidin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Progesterone IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Schistosoma mansoni immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Histology tissue cassette IVD, laboratory processing, single-use

Manufacturer:

Simport Scientific Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, calibrator

Manufacturer:

Gentian AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, reagent

Manufacturer:

Gentian AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, calibrator

Manufacturer:

Gentian AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, control

Manufacturer:

Gentian AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Retinol binding protein IVD, calibrator

Manufacturer:

Gentian AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Retinol binding protein IVD, control

Manufacturer:

Gentian AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor IX IVD, reagent

Manufacturer:

George King Bio-Medical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor prekallikrein/kallikrein IVD, control

Manufacturer:

George King Bio-Medical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor V IVD, reagent

Manufacturer:

George King Bio-Medical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VII IVD, reagent

Manufacturer:

George King Bio-Medical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII IVD, reagent

Manufacturer:

George King Bio-Medical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII-associated antigen IVD, control

Manufacturer:

George King Bio-Medical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor XI IVD, reagent

Manufacturer:

George King Bio-Medical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor XII IVD, reagent

Manufacturer:

George King Bio-Medical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lupus anticoagulant marker IVD, control

Manufacturer:

George King Bio-Medical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, control

Manufacturer:

George King Bio-Medical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prothrombin time (PT) IVD, control

Manufacturer:

George King Bio-Medical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hu antibody (anti-Hu) IVD, reagent

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Islet cell antibody IVD, reagent

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscopy mounting medium IVD

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, reagent

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple autoimmune disease-associated antibody screening IVD, kit, fluorescent immunoassay

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple myocardium antibody IVD, reagent

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Skeletal muscle antibody IVD, reagent

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple vasculitis-associated antibody IVD, reagent

Manufacturer:

HOB Biotech Group Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phospholipid antibody IVD, reagent

Manufacturer:

HOB Biotech Group Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fluid transfer set, general-purpose

Manufacturer:

MedSafety Solutions

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser control unit IVD

Manufacturer:

Apollo Biotech co., ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Radiation therapy software

Manufacturer:

Radformation, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge resin

Manufacturer:

Ray Co.,Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Alternating-pressure bed mattress system

Manufacturer:

Raye's Inc. D/B/A Sizewise Manufacturing

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, single-use

Manufacturer:

ReCor Medical Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Renal denervation ultrasound system catheter

Manufacturer:

ReCor Medical Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Renal denervation ultrasound system cooling solution flow chamber

Manufacturer:

ReCor Medical Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental etching solution

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material application tool, single-use

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental polishing cup, reusable

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentifrice

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diamond dental bur, reusable

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye splash shield, reusable

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held dental retractor

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic retainer

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic wire

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymeric dental bur

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultraviolet view box

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body-surface ultrasound imaging transducer cover

Manufacturer:

MedXPress.pro

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Mercator Medical (Thailand) Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Mercator Medical (Thailand) Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatoscope, optical

Manufacturer:

MetaOptima Technology Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device disinfection agent

Manufacturer:

METASYS Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Autopsy saw blade

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone lever/elevator, reusable

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot-switch, pneumatic

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Light source adaptor

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liposuction system

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose surgical power tool system, rechargeable battery-powered

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Needle recapping device, single-use

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrogen quick-connect coupling, female

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pneumatic surgical power tool hose

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Portable/mobile rechargeable battery pack

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sternum saw blade, single-use

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation/aspiration tubing set

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical power tool hand-switch

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical power tool system handpiece, sawing, rechargeable battery-powered

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical power tool system handpiece, wire-driving, rechargeable battery-powered

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, reciprocating, single-use

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, sagittal, single-use

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Computing visual assistive software

Manufacturer:

Microsoft Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Mighty Oak Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal pancreatic stent

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held examination/treatment light

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement, non-antimicrobial

Manufacturer:

OSARTIS GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External limb prosthesis socket liner

Manufacturer:

College Park Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External limb prosthesis socket liner

Manufacturer:

College Park Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechatronic external knee prosthesis

Manufacturer:

College Park Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Comfort Rubber Gloves Industries Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, powdered

Manufacturer:

Comfort Rubber Gloves Industries Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose donor-organ preservation/transport system

Manufacturer:

CytoSorbents Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray, single-use

Manufacturer:

dent a pharm Produktionsgesellschaft mbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Alginate dental impression material

Manufacturer:

Dental Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

Dental Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental unfilled resin sealant/coating

Manufacturer:

Dental Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Dentalpoint AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

Dentalpoint AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

Dentalpoint AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steel dental bur, reusable

Manufacturer:

Dentalpoint AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steel dental bur, reusable

Manufacturer:

Dentalpoint AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Activated clotting time (ACT) IVD, control

Manufacturer:

Pentapharm AG

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Activated protein C resistance ratio (APCR) IVD, control

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor II (prothrombin) IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor prekallikrein/kallikrein IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor V IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII IVD, kit, chromogenic

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor X IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fibrinogen assay (factor I) IVD, control

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lupus anticoagulant marker IVD, kit, clotting

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, control

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, control

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Protein C IVD, kit, clotting

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Differential/selective agar culture medium IVD

Manufacturer:

SSI Diagnostica A/S

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Salmonella species culture isolate antigen IVD, antibody

Manufacturer:

SSI Diagnostica A/S

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Streptococcus species antigen IVD, antibody

Manufacturer:

SSI Diagnostica A/S

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin S (HbS) IVD, control

Manufacturer:

Streck Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lymphocyte stabilization reagent IVD

Manufacturer:

Streck Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple CD cell marker IVD, control

Manufacturer:

Streck Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type bloodstream pathogen nucleic acid IVD, control

Manufacturer:

Streck Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

T2 Biosystems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Candida species nucleic acid IVD, control

Manufacturer:

T2 Biosystems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Candida species nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

T2 Biosystems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

T2 Biosystems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sample preparation instrument IVD

Manufacturer:

Taiwan Advance Nanotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Capillary blood collection tube IVD, ammonium heparin

Manufacturer:

Vitrex Medical a/s

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Capillary blood collection tube IVD, K2EDTA

Manufacturer:

Vitrex Medical a/s

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Capillary blood collection tube IVD, lithium heparin

Manufacturer:

Vitrex Medical a/s

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cold/cool therapy spray

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentifrice

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dishwasher detergent

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device disinfection agent

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous pole

Manufacturer:

Pryor Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose absorbent tip applicator/swab, single-use

Manufacturer:

Puritan Medical Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device sterilization/disinfection container, reusable

Manufacturer:

7D Surgical ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment handle cover, reusable

Manufacturer:

7D Surgical ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant-instrument extension adaptor, reusable

Manufacturer:

7D Surgical ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stereotactic surgery system probe, reusable

Manufacturer:

7D Surgical ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac/peripheral vascular guidewire, single-use

Manufacturer:

Abiomed, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter introduction set, nonimplantable

Manufacturer:

Abiomed, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared-light vein locator

Manufacturer:

Accuvein Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow/ankle friction/impact protector

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Freestanding headrest, reusable

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical cushion cover

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table patient pressure distribution pad, reusable

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Toilet cushion

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair back rest

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Citizen Systems Japan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Noninvasive device battery charger

Manufacturer:

Clarius Mobile Health Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Indwelling urethral catheterization kit, adult

Manufacturer:

Class Medical Ltd.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Urethral catheterization inflation safety valve

Manufacturer:

Class Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual cranial rotary handpiece, single-use

Manufacturer:

ClearPoint Neuro Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurological stereotactic surgery system

Manufacturer:

ClearPoint Neuro Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurological stereotactic surgery system

Manufacturer:

ClearPoint Neuro Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skull clamp

Manufacturer:

ClearPoint Neuro Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental matrix band retainer

Manufacturer:

Clinician's Choice Dental Products Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental matrix band, single-use

Manufacturer:

Clinician's Choice Dental Products Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental wedge, single-use

Manufacturer:

Clinician's Choice Dental Products Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Indirect binocular laser ophthalmoscope

Manufacturer:

Iridex Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous access site infiltration/extravasation monitoring system monitor

Manufacturer:

ivWatch, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous access site monitoring system fibreoptic cable, reusable

Manufacturer:

ivWatch, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Myoelectric forequarter-amputation prosthesis

Manufacturer:

Coapt, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible endoscopic scissors, single-use

Manufacturer:

Slater Endoscopy, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiography telemetric monitoring system transmitter

Manufacturer:

Boston Scientific Cardiac Diagnostics Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cervical total intervertebral disc prosthesis, modular

Manufacturer:

Spinal Kinetics LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lumbar total intervertebral disc prosthesis

Manufacturer:

Spinal Kinetics LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

SprintRay Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple-joint arm orthosis

Manufacturer:

SPIO, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple-joint lower limb orthosis

Manufacturer:

SPIO, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal applicator, single-use

Manufacturer:

SRC Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Leg splint system, self-moulding

Manufacturer:

Anatomical Concepts Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic intravenous administration set, noninvasive

Manufacturer:

Amsino International Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction system catheter, general-purpose

Manufacturer:

Amsino International Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical fluid/smoke waste management system

Manufacturer:

Amsino International Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical suction system collection container, reusable

Manufacturer:

Amsino International Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Finger-cot surgical drape

Manufacturer:

Apothecary Products, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand/finger splint, reusable

Manufacturer:

Apothecary Products, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal irrigation applicator

Manufacturer:

Apothecary Products, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Woven gauze roll/sheet

Manufacturer:

Apothecary Products, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Calibration gas cylinder regulator

Manufacturer:

Apyx Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical system generator

Manufacturer:

Apyx Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Programmable powered traction system

Manufacturer:

Pivotal Health Solutions, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Programmable powered traction system

Manufacturer:

Pivotal Health Solutions, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

Pixee Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic stereotactic surgery system

Manufacturer:

Pixee Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic stereotactic surgery system

Manufacturer:

Pixee Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-parameter urinary monitoring system control unit

Manufacturer:

Potrero Medical, Inc. dba Accuryn Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Portable active medical device mount

Manufacturer:

Potrero Medical, Inc. dba Accuryn Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Abdominal paracentesis needle, single-use

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac/peripheral vascular guidewire, single-use

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound drain connection tubing set

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound drain, non-bioabsorbable

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound drainage kit

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endomyocardial biopsy forceps, single-use

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fascial tissue dilator, single-use

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluid transfer set, general-purpose

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemostasis valve

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous line stopcock

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral vascular guidewire, manual

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter introduction needle

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vena cava filter, temporary/permanent

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical/ultrasonic surgical system generator

Manufacturer:

Asensus Surgical Italia S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Robotic surgical arm system

Manufacturer:

Asensus Surgical Italia S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Robotic surgical forceps, reusable

Manufacturer:

Asensus Surgical Italia S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Robotic surgical system

Manufacturer:

Asensus Surgical Italia S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adhesive paediatric urine collection bag, closed-ended

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Amniotic membrane perforator, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical tip cleaning pad

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope antifog solution

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraoperative ultrasound imaging transducer cover

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual scalpel blade, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Needle guide, reusable

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Needle guide, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel handle, reusable

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel handle, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-closure adhesive strip

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical penis clamp, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical vessel loop

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone curette, reusable

Manufacturer:

Avalign Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical-resistance external ankle-foot prosthesis

Manufacturer:

Axiles Bionics BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical-resistance external ankle-foot prosthesis

Manufacturer:

Axiles Bionics BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose syringe, single-use

Manufacturer:

CHIRANA T.Injecta, a. s.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Insulin syringe/needle, basic

Manufacturer:

CHIRANA T.Injecta, a. s.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual blood lancing device, single-use

Manufacturer:

SteriLance Medical(Suzhou) Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual scalpel blade, single-use

Manufacturer:

SteriLance Medical(Suzhou) Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-woven gauze pad

Manufacturer:

SteriLance Medical(Suzhou) Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel, single-use

Manufacturer:

SteriLance Medical(Suzhou) Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oral/upper respiratory tract specimen collection swab

Manufacturer:

SteriPack USA Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection adaptor, reusable

Manufacturer:

BEMER Int. AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Light-energy skin surface treatment system applicator

Manufacturer:

BEMER Int. AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Conduction blood/fluid warmer

Manufacturer:

Belmont Medical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot-switch, electrical

Manufacturer:

Stockert GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dappen dish, single-use

Manufacturer:

Sun Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneal marker handpiece tip

Manufacturer:

Surgilūm, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant extractor

Manufacturer:

Rex Implants

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant extractor

Manufacturer:

Rex Implants

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Dental implant holding endpiece

Manufacturer:

Rex Implants

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Rex Implants

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

Rex Implants

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical mallet

Manufacturer:

Rex Implants

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic endotracheal tube, single-use

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound drain, non-bioabsorbable

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound drainage kit

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Interventional radiology percutaneous-access kit, single-use

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngeal mask airway, reusable

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nephrostomy catheter

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Finger protector, single-use

Manufacturer:

FRA PRODUCTION SPA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin treatment/dressing-supportive limb/finger bandage, single-use

Manufacturer:

FRA PRODUCTION SPA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Abdominal binder, reusable

Manufacturer:

Fridababy, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infant oral pacifier

Manufacturer:

Fridababy, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pelvic floor muscle exerciser

Manufacturer:

Fridababy, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scar management dressing, reusable

Manufacturer:

Fridababy, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Inhaler dose sensor

Manufacturer:

Adherium (NZ) Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device service rail clamp

Manufacturer:

CytoSorbents Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental cavity varnish

Manufacturer:

Dental Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket adhesive

Manufacturer:

Dental Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge resin

Manufacturer:

Dental Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Zinc polycarboxylate dental cement

Manufacturer:

Dental Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Dentalpoint AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Dentalpoint AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Dentalpoint AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Dentalpoint AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gonioscope

Manufacturer:

Ocular Instruments, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Manufacturer:

Olsen Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

Clubfoot Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External lower-limb prosthesis structural/alignment component

Manufacturer:

College Park Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical-resistance external ankle-foot prosthesis

Manufacturer:

College Park Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Comfort Rubber Gloves Industries Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye pad

Manufacturer:

Maxtec, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical gas flowmeter, Thorpe tube

Manufacturer:

Maxtec, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

MD Orthopaedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip orthosis

Manufacturer:

MD Orthopaedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental ultrasonic surgical system

Manufacturer:

Mectron S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental ultrasonic surgical system handpiece tip

Manufacturer:

Mectron S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic dental scaling/debridement system

Manufacturer:

Mectron S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose centrifuge IVD

Manufacturer:

Drucker Diagnostics, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Orthopaedic/craniofacial implantation planning software

Manufacturer:

mediCAD Hectec GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medicine chamber spacer, reusable

Manufacturer:

Medical Developments International Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Medicalplastic s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breast implant delivery funnel, pneumatic

Manufacturer:

Establishment Labs S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Invasive breast implant sizer, fixed, single-use

Manufacturer:

Establishment Labs S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue expander injection port locator

Manufacturer:

Establishment Labs S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Euroteknika

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

Euroteknika

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

Euroteknika

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electronic thermometer probe cover

Manufacturer:

Exergen Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube dressing

Manufacturer:

Ferris Mfg. Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound-nonadherent dressing, permeable, non-antimicrobial

Manufacturer:

Ferris Mfg. Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

FHC, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device cleaning sponge/set

Manufacturer:

FHC, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurophysiologic monitoring system

Manufacturer:

FHC, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient surgical drape, single-use

Manufacturer:

FHC, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/implant rack

Manufacturer:

FHC, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External limb prosthesis finishing component, non-customized

Manufacturer:

Fillauer Europe AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External lower-limb prosthesis suspensory component, non-powered

Manufacturer:

Fillauer Europe AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Passive hand prosthesis

Manufacturer:

Fillauer Europe AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, thermoplastic

Manufacturer:

SCHEU-DENTAL GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, thermoplastic

Manufacturer:

SCHEU-DENTAL GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material cartridge-plunging applicator, two-component, manual

Manufacturer:

Schottlander Manufacturing GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope air/water valve, reusable

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope sheath, reusable

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic light source unit, line-powered

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic light source unit, line-powered

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment drape, single-use

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid endoscopic biopsy forceps, reusable

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid optical arthroscope, reusable

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid optical sinoscope

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arm procedure positioner, reusable

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heel stirrup

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Leg procedure positioner

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical table clamp

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table neck/shoulder positioner

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table orthopaedic extension

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating/examination/treatment table headrest, reusable

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ceramic dental bur

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, reusable

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis/implant abutment screw

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical power tool adaptor

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MLH1 antigen IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myeloperoxidase (MPO) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myogenin IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Napsin A IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

NKX protein IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

p40 protein IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pepsin IVD, reagent

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Perilipin protein IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Progesterone receptor IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

S100 protein IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Smooth muscle actin IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SOXB1 protein IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

T-cell intracytoplasmic antigen (TIA1) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum antigen IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trypsin IVD, reagent

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tyrosinase IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Uroplakin IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vascular endothelial growth factor (VEGF) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Wash/cleaning solution IVD, automated/semi-automated system

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Head-worn lamp

Manufacturer:

Designs for Vision, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical handpiece, reusable

Manufacturer:

Devroye Instruments Belgium SRL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous radio-frequency ablation system generator

Manufacturer:

DIROS TECHNOLOGY INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electromechanical lithotripsy system, extracorporeal

Manufacturer:

Dornier MedTech GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system

Manufacturer:

Dornier MedTech GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating room light

Manufacturer:

Dr. Mach GmbH & Co KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental acrylic resin

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, thermoplastic

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge resin

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental matrix band, single-use

Manufacturer:

FKG Dentaire Sàrl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic instrument chairside holder set

Manufacturer:

FKG Dentaire Sàrl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual endodontic filling material spreader

Manufacturer:

FKG Dentaire Sàrl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotary/reciprocating endodontic file/rasp, single-use

Manufacturer:

FKG Dentaire Sàrl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic enlarger, reusable

Manufacturer:

FKG Dentaire SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual endodontic file/rasp, reusable

Manufacturer:

FKG Dentaire SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic archwire/bracket ligature

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket, metal

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic metal band

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic tube

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic tube

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pliable-polymer dental regeneration membrane, non-bioabsorbable

Manufacturer:

Riverpoint Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyolefin/fluoropolymer suture, multifilament

Manufacturer:

Riverpoint Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arm procedure positioner, reusable

Manufacturer:

Kyra Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heel stirrup

Manufacturer:

Kyra Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical table clamp

Manufacturer:

Kyra Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal surgery positioning board

Manufacturer:

Kyra Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal surgery positioning board

Manufacturer:

Kyra Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental restoration fixation cleaning solution

Manufacturer:

Kuraray Noritake Dental Inc. Kurashiki

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentine bonding agent/set

Manufacturer:

Kuraray Noritake Dental Inc. Kurashiki

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentine bonding agent/set

Manufacturer:

Kuraray Noritake Dental Inc. Kurashiki

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic fixation plate, non-bioabsorbable

Manufacturer:

Laboratoires Bodycad, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anaesthesia screen

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Footrest

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Limb/torso/head restraint, reusable

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurosurgical retraction system, brain

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table mattress, basic

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table torso positioner

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skull clamp

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal surgery positioning board

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical retractor/retraction system blade, reusable

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical traction tensioner

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Universal operating table top

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Universal operating table, electrohydraulic

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

X-ray film cassette holder

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arm procedure positioner, reusable

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone lever/elevator, reusable

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External cuff/pad inflation tubing set, single-use

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Femur lifter, manual

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot-switch, electrical

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Freestanding headrest, single-use

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Freestanding patient positioner, reusable

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Freestanding patient positioner, single-use

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heel protector

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Limb/torso/head restraint, single-use

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient positioner base plate

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Traction boot

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Traction cord

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

X-ray film cassette holder

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant driver

Manufacturer:

MPS Micro Precision Systems AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

MPS Micro Precision Systems AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

MPS Micro Precision Systems AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Self-care monitoring/reporting software

Manufacturer:

Effectum Medical AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Syringe dose safety regulator

Manufacturer:

Effectum Medical AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/surgical polymerization lamp

Manufacturer:

Inter-Med, Inc.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Luer/non-ISO80369-standardized linear connector, single-use

Manufacturer:

International Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue morcellation system handpiece, line-powered

Manufacturer:

INTERSCOPE, INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant analog

Manufacturer:

ELOS Medtech Pinol A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

ELOS Medtech Pinol A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis/implant abutment screw

Manufacturer:

ELOS Medtech Pinol A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental torque wrench

Manufacturer:

ELOS Medtech Pinol A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray material

Manufacturer:

EnvisionTEC GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Denture base resin kit

Manufacturer:

EnvisionTEC GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

EOS imaging

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary basic diagnostic x-ray system, digital

Manufacturer:

EOS imaging

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

B&L Biotech, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic obturation system

Manufacturer:

B&L Biotech, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic plugger

Manufacturer:

B&L Biotech, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Periodontal curette

Manufacturer:

B&L Biotech, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Root canal post kit

Manufacturer:

B&L Biotech, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic dental scaling/debridement system handpiece tip, endodontic

Manufacturer:

B&L Biotech, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, single-use

Manufacturer:

Balt USA, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-neurovascular embolization coil

Manufacturer:

Balt USA, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular guide-catheter, single-use

Manufacturer:

Balt USA, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiation shielding panel, fixed

Manufacturer:

Radiaction Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

Ray Co.,Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental computed radiography digital imaging scanner

Manufacturer:

Ray Co.,Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental digital imaging sensor, intraoral

Manufacturer:

Ray Co.,Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray, single-use

Manufacturer:

Ray Co.,Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Renal denervation ultrasound system generator

Manufacturer:

ReCor Medical Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental etching solution

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material injection cannula, single-use

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental shaded pontic kit

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic retainer

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic wire

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Mercator Medical (Thailand) Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatoscope, optical

Manufacturer:

MetaOptima Technology Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental suction system pump

Manufacturer:

METASYS Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tap, single-use

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Calibration gas cylinder regulator

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cannulated surgical drill bit, single-use

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac ablation system irrigation tubing set

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carpal tunnel release instrument

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Drilling power tool attachment, basic

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, single-use

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, single-use

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liposuction system

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bur, single-use

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant-instrument extension adaptor, reusable

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sawing power tool attachment, reciprocating

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill chuck

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument protective cap

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical power tool system control unit, line-powered

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical power tool system handpiece, wire-driving, pneumatic

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/orthopaedic lavage control unit

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wire-driving power tool attachment

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic electrode connector

Manufacturer:

Curbell Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee/ankle/foot orthosis

Manufacturer:

Lenjoy Medical Engineering, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incentive spirometer

Manufacturer:

Leventon, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing needle, single-use

Manufacturer:

Lincotek Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electroretinograph

Manufacturer:

LKC Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electroretinograph electrode

Manufacturer:

LKC Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heart valve prosthesis holder, reusable

Manufacturer:

LSI SOLUTIONS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operative-site suture holder

Manufacturer:

LSI SOLUTIONS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mental health/function therapeutic software, screen-viewed

Manufacturer:

Mahana Therapeutics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Conduction blood/fluid warmer

Manufacturer:

Ace Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elastomeric infusion pump system

Manufacturer:

Ace Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral anaesthesia catheter set, medicated

Manufacturer:

Ace Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-coring punch, single-use

Manufacturer:

ACUDERM, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction system filter, microbial

Manufacturer:

AG Industries LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgical dye

Manufacturer:

ALFA INSTRUMENTS S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cotton wool ball, sterile

Manufacturer:

American Surgical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurosurgical sponge

Manufacturer:

American Surgical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous administration tubing extension set

Manufacturer:

Angiodroid SpA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cryogenic laboratory freezer, liquid nitrogen

Manufacturer:

Arctic Solutions, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Appetite-suppression gastric balloon

Manufacturer:

Apollo Endosurgery, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastrointestinal suture anchor

Manufacturer:

Apollo Endosurgery, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyolefin/fluoropolymer suture, monofilament

Manufacturer:

Apollo Endosurgery, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suture/ligature tightener, single-use

Manufacturer:

Apollo Endosurgery, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood storage solution, anticoagulation

Manufacturer:

Arteriocyte Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Musculoskeletal/physical therapy laser, home-use

Manufacturer:

ASA s.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Musculoskeletal/physical therapy laser, professional

Manufacturer:

ASA s.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Contact lens disinfecting solution

Manufacturer:

AVIZOR S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye lubricant

Manufacturer:

AVIZOR S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye lubricant

Manufacturer:

AVIZOR S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft/rigid contact lens cleaning solution

Manufacturer:

AVIZOR S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Programmable ambulation exoskeleton, clinical

Manufacturer:

B-Temia Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Programmable ambulation exoskeleton, home-use

Manufacturer:

B-Temia Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal intracranial vascular stent

Manufacturer:

Balt Extrusion SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter introduction set, nonimplantable

Manufacturer:

Balt Extrusion SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular microcatheter

Manufacturer:

Balt Extrusion SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose brachytherapy system applicator, remote-afterloading

Manufacturer:

Best Medical International, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intermittent venous compression system

Manufacturer:

Bio Compression Systems, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-chamber venous compression system garment, reusable

Manufacturer:

Bio Compression Systems, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sequential venous compression system pump

Manufacturer:

Bio Compression Systems, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-organic haemostatic agent

Manufacturer:

Biolife, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, oscillating, single-use

Manufacturer:

Brasseler USA Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bronchoscopic catheter

Manufacturer:

Broncus Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary oxygen concentrator

Manufacturer:

Caire Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac ablation laser system beam guide-catheter

Manufacturer:

CARDIOFOCUS INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac ablation solid-state laser system

Manufacturer:

CARDIOFOCUS INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemostasis valve

Manufacturer:

CARDIOFOCUS INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular balloon catheter fill-media

Manufacturer:

CARDIOFOCUS INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

Cercare Medical A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

Cercare Medical A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

Cercare Medical A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

Cercare Medical A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile multi-spectral vascular imaging device

Manufacturer:

Christie Medical Holdings, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastro-oesophageal pH/electrical impedance catheter

Manufacturer:

Chongqing Jinshan Science& Technology (Group) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastrointestinal telemetric monitoring system capsule, ingestible

Manufacturer:

Chongqing Jinshan Science& Technology (Group) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video capsule endoscopy system capsule

Manufacturer:

Chongqing Jinshan Science& Technology (Group) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General surgical procedure kit, non-medicated, single-use

Manufacturer:

Crown Aesthetics

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device-irrigation sterile water

Manufacturer:

D.B.M. S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Demand valve

Manufacturer:

DEHAS Medical Systems GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General/multiple surgical laser system beam guide, reusable

Manufacturer:

Dornier MedTech America, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal pH suppository

Manufacturer:

Dr. August Wolff GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone-conduction tinnitus masker

Manufacturer:

Duearity AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac electrophysiology processing software

Manufacturer:

Eko Health, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electronic stethoscope

Manufacturer:

Eko Health, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, reusable

Manufacturer:

Edenta Establissement

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Root canal post, preformed

Manufacturer:

Edenta Establissement

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steel dental bur, reusable

Manufacturer:

Edenta Establissement

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haematological concentrate system preparation kit, platelet concentration

Manufacturer:

EmCyte Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Home seizure monitoring system

Manufacturer:

Empatica S.r.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic overtube, single-use

Manufacturer:

Endo Tools Therapeutics S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electroporation therapy system

Manufacturer:

Eunsung Global Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Musculoskeletal/physical therapy laser beam guide, transcutaneous

Manufacturer:

Eunsung Global Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Needleless medication/vaccine injector, mechanical

Manufacturer:

European Pharma Group B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Extracorporeal ultrasound imaging transducer, hand-held

Manufacturer:

Exact Imaging Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose ultrasound imaging system

Manufacturer:

Exact Imaging Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Needle guide, reusable

Manufacturer:

Exact Imaging Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Needle guide, single-use

Manufacturer:

Exact Imaging Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraluminal circular stapler, single-use

Manufacturer:

Ezisurg Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft-tissue ultrasonic surgical system

Manufacturer:

Ezisurg Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical staple loading unit, non-cutting

Manufacturer:

Ezisurg Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic motorized cutting stapler, single-use

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue extraction bag

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ambulatory fall sensor

Manufacturer:

Fitbit LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Empty self-injector, electronic

Manufacturer:

Phillips Medisize A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiopulmonary bypass system heat exchanger, reusable

Manufacturer:

Quest Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiopulmonary bypass system valve, unidirectional flow/pressure control

Manufacturer:

Quest Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgical procedure kit, non-medicated, single-use

Manufacturer:

Quest Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone marrow biopsy needle, single-use

Manufacturer:

Ranfac Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing unit, single-use

Manufacturer:

Ranfac Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical cable adaptor

Manufacturer:

REMINGTON MEDICAL INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastric band access port kit

Manufacturer:

ReShape Lifesciences

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infusion/injection port/tack applicator

Manufacturer:

ReShape Lifesciences

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

Riverain Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

Restorative Therapies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video bronchoscope, single-use

Manufacturer:

Shanghai Anqing Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video choledochoscope, single-use

Manufacturer:

Shanghai Anqing Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video cystoscope, single-use

Manufacturer:

Shanghai Anqing Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video ureterorenoscope, single-use

Manufacturer:

Shanghai Anqing Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone marrow biopsy needle, single-use

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Epidural anaesthesia set, non-medicated

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Epidural anaesthesia set, non-medicated

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Epiduroscopic catheter

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose surgical suction system, electric

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haematological concentrate/haemostatic agent applicator

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radio-frequency ablation system

Manufacturer:

Seawon Meditech Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular modelling software

Manufacturer:

Shanghai Pulse Medical Technology,Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular modelling software

Manufacturer:

Shanghai Pulse Medical Technology,Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acupuncture electrical stimulation system

Manufacturer:

SHENB Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microwave diathermy treatment system

Manufacturer:

SHENB Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrogen plasma skin surface treatment system

Manufacturer:

SHENB Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

Sim&Cure

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Whole-blood-recovery autotransfusion system, powered

Manufacturer:

3T Medical System, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Linear accelerator system

Manufacturer:

Accuray Incorporated

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiation therapy treatment planning workstation

Manufacturer:

Accuray Incorporated

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiation therapy treatment planning workstation

Manufacturer:

Accuray Incorporated

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal biliary stent

Manufacturer:

BCM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal ureteral stent

Manufacturer:

BCM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal colonic stent

Manufacturer:

BCM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MOSFET radiation therapy dosimetry system

Manufacturer:

Best Theratronics

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Teletherapy radionuclide system table, powered

Manufacturer:

Best Theratronics

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical system generator

Manufacturer:

Bolder Surgical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Activated protein C resistance ratio (APCR) IVD, control

Manufacturer:

Pentapharm AG

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Reptilase time IVD, kit, clotting

Manufacturer:

Pentapharm AG

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Personal Genome Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, automated/semi-automated system

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor II (prothrombin) IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor IX IVD, kit, chromogenic

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor IX IVD, kit, chromogenic

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor IX IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VII IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII IVD, kit, chromogenic

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor X IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor XI IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor XII IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor XII IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lupus anticoagulant marker IVD, control

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lupus anticoagulant marker IVD, control

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lupus anticoagulant marker IVD, kit, clotting

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lupus anticoagulant marker IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Protein S IVD, kit, clotting

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Escherichia coli antigen IVD, antibody

Manufacturer:

SSI Diagnostica A/S

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory bacteria antigen IVD, kit, rapid ICT, clinical

Manufacturer:

SSI Diagnostica A/S

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptococcus pneumoniae culture isolate antigen IVD, antibody

Manufacturer:

SSI Diagnostica A/S

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptococcus pneumoniae total antibody IVD, reagent

Manufacturer:

SSI Diagnostica A/S

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electric pad whole-body heating system

Manufacturer:

Augustine Temperature Management, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Augustine Temperature Management, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone file/rasp, manual, reusable

Manufacturer:

Avalign Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant/trial-implant/sizer holder, reusable

Manufacturer:

Avalign Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Insulin syringe/needle, basic

Manufacturer:

CHIRANA T.Injecta, a. s.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tuberculin/allergy syringe/needle, safety

Manufacturer:

CHIRANA T.Injecta, a. s.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood pressure cuff, reusable

Manufacturer:

Citizen Systems Japan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient surgical drape, single-use

Manufacturer:

ClearPoint Neuro Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray, single-use

Manufacturer:

Clinician's Choice Dental Products Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing/utility forceps, scissors-like, reusable

Manufacturer:

Clinician's Choice Dental Products Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General/multiple surgical frequency-doubled solid-state laser system

Manufacturer:

Iridex Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laser adaptor

Manufacturer:

Iridex Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic laser system beam guide

Manufacturer:

Iridex Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument/analyser specimen/reagent container carrier IVD

Manufacturer:

XEOS Medical

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Diagnostic peripheral nerve electrical stimulation system

Manufacturer:

Xavant Technology (Pty) Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Limb/torso/head restraint, single-use

Manufacturer:

Xodus Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Upper-limb traction wrap/trap, single-use

Manufacturer:

Xodus Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vial/bottle adaptor, hermetic

Manufacturer:

Yukon Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vial/bottle adaptor, non-hermetic

Manufacturer:

Yukon Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stomal appliance skin-adherent patch

Manufacturer:

Freudenberg Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray, single-use

Manufacturer:

G and H Wire Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic metal band

Manufacturer:

G and H Wire Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic tube

Manufacturer:

G and H Wire Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental delivery system

Manufacturer:

Antoni Carles S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acupressure wristband

Manufacturer:

Apothecary Products, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cast/bandage waterproof bathing cover, reusable

Manufacturer:

Apothecary Products, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ear canal irrigation syringe

Manufacturer:

Apothecary Products, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood donation rocker

Manufacturer:

Applied Science Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical return electrode, single-use

Manufacturer:

Apyx Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot-switch, electrical

Manufacturer:

Apyx Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Head/neck procedure positioner

Manufacturer:

Pivotal Health Solutions, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic stereotactic surgery system

Manufacturer:

Pixee Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, reusable

Manufacturer:

Pixee Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, reusable

Manufacturer:

Pixee Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, reusable

Manufacturer:

Pixee Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Potrero Medical, Inc. dba Accuryn Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-parameter urinary monitoring system catheter set

Manufacturer:

Potrero Medical, Inc. dba Accuryn Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transportable medical equipment stand, non-powered

Manufacturer:

Potrero Medical, Inc. dba Accuryn Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood transfusion filter

Manufacturer:

Inari Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thrombectomy rotational catheter

Manufacturer:

Inari Medical

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Thrombectomy suction catheter

Manufacturer:

Inari Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thrombectomy suction catheter

Manufacturer:

Inari Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thrombectomy wire-net

Manufacturer:

Inari Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Capillary blood collection tube IVD, sodium heparin

Manufacturer:

Vitrex Medical a/s

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental etching solution

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental etching solution

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression material adhesive

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument maintenance lubricant

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Puritan Medical Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose absorbent tip applicator/swab, single-use

Manufacturer:

Puritan Medical Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Erythrocyte sedimentation rate (ESR) IVD, control

Manufacturer:

Streck Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Evacuated blood collection tube IVD, anticoagulant

Manufacturer:

Streck Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Full blood count IVD, control

Manufacturer:

Streck Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Taiwan Advance Nanotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Osmolality IVD, control

Manufacturer:

Trukera Medical

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Osmometric analyser IVD

Manufacturer:

Trukera Medical

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

Amann Girrbach AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bladder irrigation kit

Manufacturer:

Amsino International Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Indwelling urethral drainage balloon catheter, non-antimicrobial

Manufacturer:

Amsino International Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction/irrigation tubing, single-use

Manufacturer:

Amsino International Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial

Manufacturer:

Amsino International Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin (HCG) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Manufacturer:

Genomadix Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

Simport Scientific Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, control

Manufacturer:

Gentian AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor X IVD, reagent

Manufacturer:

George King Bio-Medical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Autologous adipose tissue collection/injection set

Manufacturer:

Musculoskeletal Transplant Foundation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI system application software

Manufacturer:

Myocardial Solutions, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing needle holder, single-use

Manufacturer:

Asensus Surgical Italia S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biological stain IVD

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, manual

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Endomysium antibody (EMA) IVD, reagent

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry protein IVD, kit, immunoblot

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Skin antibody IVD, kit, fluorescent immunoassay

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, kit, chemiluminescent immunoassay

Manufacturer:

HOB Biotech Group Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Coeliac disease-associated antibody IVD, reagent

Manufacturer:

HOB Biotech Group Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple diabetes mellitus-associated antibody IVD, reagent

Manufacturer:

HOB Biotech Group Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple liver disease-associated antibody IVD, reagent

Manufacturer:

HOB Biotech Group Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple myositis-associated antibody IVD, kit, multiplex

Manufacturer:

HOB Biotech Group Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple rheumatoid arthritis-associated antibody IVD, reagent

Manufacturer:

HOB Biotech Group Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phospholipase A2 receptor (PLA2R) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

HOB Biotech Group Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Biliary drain

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body aspiration needle, single-use

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breast ductography cannula

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

End-cut biopsy gun handpiece/needle

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

End-cut biopsy gun needle

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intrauterine imaging medium catheter

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose percutaneous abdominothoracic drainage catheter

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-vascular catheter introduction set

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Prostate brachytherapy system applicator, manual

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiographic procedure tubing

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological image marker, implantable

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thrombectomy rotational catheter

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter introduction set, nonimplantable

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wearable percutaneous catheter/tube holder

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible endoscopic tissue manipulation forceps, single-use

Manufacturer:

Asensus Surgical Italia S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Robotic surgical arm system

Manufacturer:

Asensus Surgical Italia S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft-tissue ultrasonic robotic surgical instrument, single-use

Manufacturer:

Asensus Surgical Italia S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft-tissue ultrasonic surgical system transducer/tip

Manufacturer:

Asensus Surgical Italia S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose medical fibre padding

Manufacturer:

ATHFAR 828, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adhesive paediatric urine collection bag, open-ended

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body-orifice ultrasound imaging transducer cover, basic

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Light source adaptor

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment handle cover, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment/instrument drape, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Needle guide, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Needle guide, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin marking pen, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-closure adhesive strip

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing needle, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing unit, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing unit, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stereotactic surgery system probe, reusable

Manufacturer:

7D Surgical ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

7D Surgical ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cannula clamp

Manufacturer:

Abiomed, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Catheter orifice occluder

Manufacturer:

Abiomed, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, single-use

Manufacturer:

Abiomed, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infusion pump cassette

Manufacturer:

Abiomed, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intracardiac circulatory assist axial-pump catheter

Manufacturer:

Abiomed, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intracardiac circulatory assist axial-pump catheter control unit

Manufacturer:

Abiomed, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant template, single-use

Manufacturer:

Abiomed, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac mapping catheter, percutaneous, single-use

Manufacturer:

Access Point Technologies EP Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Freestanding patient positioner, reusable

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gel-filled bed mattress overlay

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gel-filled chair cushion

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heel stirrup cushion/pad

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stool cushion

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arthrodesis nail, fixed-length

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tap, reusable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General internal orthopaedic fixation system implantation kit

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General internal orthopaedic fixation system implantation kit

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Humerus nail

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone wire

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic fixation plate bending insert, reusable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant/instrument assembling device

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant template, reusable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, torque-limiting

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, oscillating, single-use

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Alpha-fetoprotein (AFP) IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Androgen receptor IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Basal cell cocktail IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Biological stain IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

BRCA1 protein IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, manual

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD, automated/semi-automated system

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carcinoembryonic antigen (CEA) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Caspase-3 IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD163 cell marker IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD19 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD23 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD28 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD3 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD31 endothelial cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD34 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD5 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD54 Intercellular adhesion molecule-1 (ICAM-1) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD68 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD8 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII-associated antigen IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Collagen type IV IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cyclin D1 IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Decalcifying solution IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epidermal growth factor receptor (EGFR) IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epithelial specific antigen (ESA) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Excision repair cross-complementing (ERCC) protein IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Galectin-3 IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glial fibrillary acidic protein (GFAP) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glutamine synthetase IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Granzyme B IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatocyte specific antigen IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry antibody detection IVD, reagent

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry antibody diluent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry antigen retrieval reagent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry endogenous avidin/biotin dual blocking reagent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry endogenous enzyme blocking reagent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry endogenous protein blocking reagent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry protease kit IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry wash buffer reagent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inhibin A IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin-like growth factor I (IGF1) IVD, reagent

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interferon gamma release IVD, reagent

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Kappa/lambda light chain immunoglobulin IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microphthalmia-associated transcription factor (MITF) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bedside infusion pump, single-channel

Manufacturer:

Jubilant Draximage Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

Manufacturer:

Lacey Manufacturing Company, LLC / Boston EndoSurgical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastro-urological guidewire, single-use

Manufacturer:

Lake Region Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation/aspiration tubing set

Manufacturer:

Lagis Enterprise Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation/aspiration tubing set

Manufacturer:

Lagis Enterprise Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Abdominal aorta endovascular stent-graft

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac defect occluder

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Descending thoracic aorta endovascular stent-graft

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravascular extraction catheter-snare

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vena cava filter, temporary/permanent

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General/multiple surgical frequency-doubled solid-state laser system

Manufacturer:

LUTRONIC Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radio-frequency skin surface treatment system

Manufacturer:

LUTRONIC Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial

Manufacturer:

MedXL Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial

Manufacturer:

MedXL Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology picture archiving and communication system workstation

Manufacturer:

Merge Healthcare Incorporated

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology picture archiving and communication system workstation

Manufacturer:

Merge Healthcare Incorporated

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hygroscopic dental cement

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Antimicrobial wound irrigation solution, sterile

Manufacturer:

Next Science LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical gas flowmeter, Thorpe tube

Manufacturer:

Ohio Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vacuum suction regulator/regulation set, general-purpose

Manufacturer:

Ohio Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical mesh, metal/polymer

Manufacturer:

Osteogenics Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical mesh, metal/polymer

Manufacturer:

Osteogenics Biomedical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube speech valve

Manufacturer:

Passy-Muir, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

Novosanis NV

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Histology/cytology/microbiology image-analysis interpretive software IVD

Manufacturer:

Paige.AI, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bone growth ultrasonic stimulator

Manufacturer:

Bioventus LLC

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Noninvasive device battery charger

Manufacturer:

Bioventus LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

Bisco, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin kit

Manufacturer:

Bisco, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental etching solution

Manufacturer:

Bisco, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental unfilled resin sealant/coating

Manufacturer:

Bisco, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oropharyngeal mucosa protection material

Manufacturer:

bitop AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electroencephalographic monitoring system

Manufacturer:

Bittium Biosignals Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polysomnograph

Manufacturer:

Bittium Biosignals Ltd

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Liposuction system cannula, single-use

Manufacturer:

Black Tie Medical Inc. DBA Tulip Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lumbar decompression interspinous spacer

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual orthopaedic bender, reusable

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant abutment analog, scanning

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant abutment analog, scanning

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental osteotome

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cervical total intervertebral disc prosthesis, one-piece

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device sterilization/disinfection container, reusable

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal dynamic-stabilization system

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, torque-limiting

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mastication muscle exerciser

Manufacturer:

Speech Pathology Associates, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, reusable

Manufacturer:

Spinal Kinetics LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal applicator, reusable

Manufacturer:

SRC Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Autoinjector needle

Manufacturer:

SteriLance Medical(Suzhou) Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood lancet, single-use

Manufacturer:

SteriLance Medical(Suzhou) Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual blood lancing device, reusable

Manufacturer:

SteriLance Medical(Suzhou) Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual blood lancing device, single-use

Manufacturer:

SteriLance Medical(Suzhou) Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual scalpel blade, single-use

Manufacturer:

SteriLance Medical(Suzhou) Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-woven gauze pad

Manufacturer:

SteriLance Medical(Suzhou) Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel, single-use

Manufacturer:

SteriLance Medical(Suzhou) Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held deep-tissue electromagnetic stimulator

Manufacturer:

BEMER Int. AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Conduction blood/fluid warmer set

Manufacturer:

Belmont Medical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External circulating-fluid core temperature regulation system pad, single-use

Manufacturer:

Belmont Medical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heat-exchanging intravenous administration set

Manufacturer:

Belmont Medical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intracavitary-circulation hyperthermia system

Manufacturer:

Belmont Medical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Warming/high-flow infusion pump

Manufacturer:

Belmont Medical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Balance/cognitive function analysis system

Manufacturer:

Bertec Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posturography system platform

Manufacturer:

Bertec Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac radio-frequency ablation system generator

Manufacturer:

Stockert GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Stockert GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dappen dish holder

Manufacturer:

Sun Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin kit

Manufacturer:

Sun Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material application tool, single-use

Manufacturer:

Sun Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material injection cannula, single-use

Manufacturer:

Sun Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Home-use sleep apnoea recording system

Manufacturer:

Sunrise SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneal marker handpiece

Manufacturer:

Surgilūm, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, reusable

Manufacturer:

Rex Implants

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Maxillofacial bone separator

Manufacturer:

Rex Implants

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

Rex Implants

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

Rex Implants

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Rex Implants

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biliary drain

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foetal vacuum extraction system cup, reusable

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastric calibration tube, sterile

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Indwelling urethral drainage balloon catheter, non-antimicrobial

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal haemostatic balloon

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oxygen administration tubing

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pleural catheter

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulmonary resuscitator, manual, single-use

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suprapubic drainage catheter

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical capillary wound drain, luminal, synthetic polymer

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical tissue/fluid collection bag

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical vessel loop

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube, non-reinforced, non-customized, single-use

Manufacturer:

Fortune Medical Instrument Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Abdominal binder, reusable

Manufacturer:

FRA PRODUCTION SPA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Coronary optical coherence tomography system catheter

Manufacturer:

Gentuity, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-rechargeable public automated external defibrillator

Manufacturer:

HeartHero, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Reverse-osmosis water purification system

Manufacturer:

Herco Wassertechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravascular near-infrared spectroscopy imaging system

Manufacturer:

Infraredx, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravascular near-infrared spectroscopy imaging system catheter

Manufacturer:

Infraredx, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasound hyperthermia system transducer, extracorporeal

Manufacturer:

Jeisys Medical Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Femtosecond ophthalmic solid-state laser system

Manufacturer:

LENSAR, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation system nozzle

Manufacturer:

Medaxis AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal colonic stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal colonic stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal duodenal stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal tracheal/bronchial stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal colonic stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal pancreatic stent

Manufacturer:

M.I.Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyolefin/fluoropolymer suture, multifilament

Manufacturer:

Mesh Suture Inc. dba MSi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bioelectrical signal analysis software

Manufacturer:

Micromed SpA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electromyograph

Manufacturer:

Micromed SpA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical utensil washer/disinfector

Manufacturer:

Miele & Cie. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye valve

Manufacturer:

New World Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulse oximeter probe, reusable

Manufacturer:

Nonin Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical cable adaptor

Manufacturer:

Olsen Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Manufacturer:

Olsen Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical electrode, monopolar, reusable

Manufacturer:

Olsen Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

Manufacturer:

Promed Supply Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-tumour low-voltage therapeutic x-ray system

Manufacturer:

Sensus Healthcare

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Data storage card

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Donor-organ preservation/transport perfusion initiation/termination set

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Donor-organ preservation/transport perfusion initiation/termination set

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Donor-organ preservation/transport perfusion set connection kit

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gas/fluid regulator gasket

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heart donor-organ preservation/transport perfusion set

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heart donor-organ preservation/transport perfusion set

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heart donor-organ preservation/transport system

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heart donor-organ preservation/transport system

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liver donor-organ preservation/transport perfusion set

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liver donor-organ preservation/transport perfusion set

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liver donor-organ preservation/transport system

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liver donor-organ preservation/transport system

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lung donor-organ preservation/transport perfusion set

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lung donor-organ preservation/transport perfusion set

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lung donor-organ preservation/transport system

Manufacturer:

TransMedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tap, reusable

Manufacturer:

TRI Dental Implants Int. AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

TRI Dental Implants Int. AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic electric hospital bed

Manufacturer:

Umano Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bedside monitor remote-viewing software, non-physiological parameter

Manufacturer:

Umano Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous pole

Manufacturer:

Umano Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound/centesis drainage receptacle

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Luer/non-ISO80369-standardized linear connector, single-use

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Luer/non-ISO80369-standardized linear connector, single-use

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction system catheter, general-purpose

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction system catheter, general-purpose

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction system catheter, general-purpose

Manufacturer:

UreSil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Assistive pushchair

Manufacturer:

Vermeiren Group

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile patient lifting system, electrically-powered

Manufacturer:

Vermeiren Group

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

Versah, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

Versah, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

Versah, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray material

Manufacturer:

Vertex-Dental B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Synthetic polymer semi-permeable film dressing, wound-nonadherent

Manufacturer:

Bio Med Sciences, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound-nonadherent dressing, permeable, non-antimicrobial

Manufacturer:

Bio Med Sciences, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gait-enhancement electrical stimulation system, external

Manufacturer:

Bioness, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gait-enhancement electrical stimulation system, external

Manufacturer:

Bioness, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gait-enhancement electrical stimulation system, external

Manufacturer:

Bioness, Inc.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

Bioness, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cervical spine collar, reusable

Manufacturer:

VQ OrthoCare

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Aspiration tray, single-use

Manufacturer:

Walk Vascular, LLC

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Mechanical atherectomy/thrombectomy drive system

Manufacturer:

Walk Vascular, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction/irrigation tubing, single-use

Manufacturer:

Walk Vascular, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thrombectomy suction catheter

Manufacturer:

Walk Vascular, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiographic image marker, manual

Manufacturer:

Webb Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medication transfer set

Manufacturer:

West Pharma. Services IL, Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vial/bottle adaptor, hermetic

Manufacturer:

West Pharma. Services IL, Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Metallic spinal interbody fusion cage

Manufacturer:

SIGNUS Medizintechnick GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, single-use

Manufacturer:

SIGNUS Medizintechnick GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymeric spinal interbody fusion cage

Manufacturer:

SIGNUS Medizintechnick GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal fixation plate, non-bioabsorbable

Manufacturer:

SIGNUS Medizintechnick GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oral care swab

Manufacturer:

Sion Biotext Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow radius prosthesis

Manufacturer:

Skeletal Dynamics, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Manufacturer:

Skeletal Dynamics, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic fixation plate, non-bioabsorbable

Manufacturer:

Skeletal Dynamics, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, torque-limiting

Manufacturer:

Skeletal Dynamics, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal aspirator, manual

Manufacturer:

Fridababy, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arthrodesis nail, fixed-length

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone awl, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone nail guidewire, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Femur nail

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip internal fixation system

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual wire driver

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Metacarpal prosthesis

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nerve/vessel retractor

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nerve/vessel retractor

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant driver

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic instrument surgical connector

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical countersink, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical depth gauge, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant template, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant template, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/implant rack

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical mallet

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical power tool adaptor

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical power tool adaptor

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone cutter

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone lever/elevator, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cartilage knife

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cartilage knife

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clamp manipulation forceps

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dissection sponge

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing/utility forceps, tweezers-like, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ear speculum, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENT soft-tissue cutting forceps

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fistula probe

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Meniscus knife

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microlaryngeal probe

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Middle ear pick

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mouth gag, non-adjustable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nail clippers, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal knife

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery dissector

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic joint/limb rongeur

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ring cutter

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel handle, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin marking guide, single-use

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-coring punch, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal rongeur

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sponge bowl, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sternum knife

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical retraction system mounting frame, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/emergency suction cannula, non-illuminating, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing needle, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tonsil knife

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Towel clamp, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheal surgery dilator, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Uterine sound, reusable

Manufacturer:

Symmetry Surgical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal biliary stent

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal duodenal stent

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose endoscopic needle, single-use

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oesophageal stent extractor

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal biliary stent, non-bioabsorbable

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal tracheal/bronchial stent

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal urethral stent

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymeric ureteral stent

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular compressor, external

Manufacturer:

Taewoong Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Indica Labs

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Endoscopic video image interpretive software

Manufacturer:

NEC Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI image enhancement padding

Manufacturer:

NeoCoil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient audiovisual communication/entertainment system

Manufacturer:

NeoCoil, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental drill bit extension

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, medicated, reusable

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Neobiotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing-fixation skin adhesive tape, silicone

Manufacturer:

Neotech Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical cable/lead holder

Manufacturer:

Neotech Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neonatal electrocardiographic electrode

Manufacturer:

Neotech Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Personal device holder, single-use

Manufacturer:

Neotech Products LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood collection tube holder, single-use

Manufacturer:

ITL Asia Pacific Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood collection tube holder, single-use

Manufacturer:

ITL Asia Pacific Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood donor bag segment sampling IVD

Manufacturer:

ITL Asia Pacific Sdn. Bhd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood/blood culture specimen transfer spike IVD

Manufacturer:

ITL Asia Pacific Sdn. Bhd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electrosurgical handpiece/electrode holder, single-use

Manufacturer:

ITL Asia Pacific Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical tubing clip/clamp, permanent

Manufacturer:

ITL Asia Pacific Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Syringe/blood collection tube adaptor IVD

Manufacturer:

ITL Asia Pacific Sdn. Bhd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container insert tube IVD

Manufacturer:

Precision System Science Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory waste receptacle IVD

Manufacturer:

Precision System Science Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Magnetic particle separation instrument IVD

Manufacturer:

Precision System Science Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Precision System Science Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pipette tip IVD

Manufacturer:

Precision System Science Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Proscia, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ophthalmic tonometer, manual

Manufacturer:

Ocular Instruments, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vitrectomy contact lens, reusable

Manufacturer:

Ocular Instruments, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incontinence pants, reusable

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incontinence pants, single-use

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Absorbent underpad, non-antimicrobial, single-use

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incontinence pants liner

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electromechanical operating table base

Manufacturer:

OPT SurgiSystems S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Universal operating table, electrohydraulic

Manufacturer:

OPT SurgiSystems S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External orthopaedic fixation system, single-use

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Femur nail

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Growth-correction orthopaedic fixation plate kit

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple-joint lower limb orthosis

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, reusable

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, reusable

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, reusable

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Trans-facet-screw internal spinal fixation system, sterile

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Trans-facet-screw internal spinal fixation system, sterile

Manufacturer:

OrthoPediatrics Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual orthopaedic cement mixer, single-use

Manufacturer:

OSARTIS GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental cheek retractor, professional, reusable

Manufacturer:

Great Lakes Dental Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental dry field kit

Manufacturer:

Great Lakes Dental Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mouthguard, reusable

Manufacturer:

Great Lakes Dental Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic extraoral headgear

Manufacturer:

Great Lakes Dental Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilization packaging, single-use

Manufacturer:

GS Medical Packaging Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, single-use

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ceramic dental bur

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cranial bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive strip, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental power tool handpiece motorless component

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental-professional prophylaxis brush, single-use

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic broach, serrated, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pin/post dental drill bit

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Podiatric bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotary/reciprocating endodontic file/rasp, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steel dental bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steel dental bur, single-use

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilizer/disinfector rack

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sternum saw blade, single-use

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone curette, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental elevator, sinus lift

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental osteotome

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis/implant abutment screw

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Gauze packer

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General/plastic surgery bur

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held dental retractor

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Periotome, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing needle holder, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac electrophysiology processing software

Manufacturer:

Boston Scientific Cardiac Diagnostics Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical handpiece, single-use

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical system

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope sheath, single-use

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical electrode, monopolar, single-use

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical plume evacuation system

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical plume evacuation system tube

Manufacturer:

Bovie Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Bradshaw Medical Inc. (dba Intech)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical vice grip

Manufacturer:

Bradshaw Medical Inc. (dba Intech)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone/joint surgical power tool motorized handpiece/set, electric, single-use

Manufacturer:

Osteonic Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Craniofacial fixation plate, non-bioabsorbable, non-customized

Manufacturer:

Osteonic Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cranioplasty plate, non-alterable

Manufacturer:

Osteonic Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

Osteonic Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implantable-device cutter

Manufacturer:

Osteonic Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant handling forceps

Manufacturer:

Osteonic Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tendon/ligament bone anchor, bioabsorbable

Manufacturer:

Osteonic Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tendon/ligament bone anchor, non-bioabsorbable

Manufacturer:

Osteonic Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Catheter/tubing connection protector

Manufacturer:

CAIR LGL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENFit oral/enteral syringe, single-use

Manufacturer:

CAIR LGL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Enteral feeding noninvasive-component set

Manufacturer:

CAIR LGL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous line stopcock

Manufacturer:

CAIR LGL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasoenteral tube

Manufacturer:

CAIR LGL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neutral-pressure intravenous line needleless valve-connector

Manufacturer:

CAIR LGL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

Lab Kinetics LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Denture reliner, hard

Manufacturer:

Tokuyama Dental Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic electrode, single-use

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multifunction cardiac electrode, adult

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin topical coupling gel

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Psychophysiological biofeedback system

Manufacturer:

Thought Technology Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Limb/torso/head restraint, reusable

Manufacturer:

TIDI Product, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment/instrument drape, single-use

Manufacturer:

TIDI Product, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urological fluid funnel

Manufacturer:

TIDI Product, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urological fluid funnel

Manufacturer:

TIDI Product, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wearable percutaneous catheter/tube holder

Manufacturer:

TIDI Product, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wearable percutaneous catheter/tube holder

Manufacturer:

TIDI Product, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic insufflation tubing set, single-use

Manufacturer:

Northgate Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Insufflation gas conditioning system

Manufacturer:

Northgate Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laparoscopic insufflator

Manufacturer:

Northgate Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laparoscopic plume filter

Manufacturer:

Northgate Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI system coil, radio-frequency

Manufacturer:

Nova Medical Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI system coil, radio-frequency

Manufacturer:

Nova Medical Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope working-channel valve, single-use

Manufacturer:

OBP Medical Corporation DBA OBP Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal speculum, single-use

Manufacturer:

OBP Medical Corporation DBA OBP Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal oxygen cannula, basic

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal oxygen cannula, CPAP

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nebulizing system delivery set, single-use

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oxygen administration tubing

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rebreathing oxygen face mask

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ventilator breathing circuit, single-use

Manufacturer:

GaleMed Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac/peripheral vascular guidewire, single-use

Manufacturer:

Galt Medical Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound drain, non-bioabsorbable

Manufacturer:

Galt Medical Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymeric spinal interbody fusion cage

Manufacturer:

GetSet Surgical SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral angioplasty balloon catheter, basic

Manufacturer:

Goodman Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye dropper bottle

Manufacturer:

Heinz Meise GmbH Medizintechnik

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic archwire

Manufacturer:

Highland Metals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bur, reusable

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical electrode, bipolar, single-use

Manufacturer:

IMEDICOM Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

inHEART

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft corrective contact lens, daily-disposable

Manufacturer:

Innova Vision Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile/portable oxygen concentrator

Manufacturer:

Inogen, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile/portable oxygen concentrator

Manufacturer:

Inogen, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material injection cannula, single-use

Manufacturer:

Innovative BioCeramix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biliary/urinary stone retrieval basket, single-use

Manufacturer:

INNOVEX MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastro-urological guidewire, single-use

Manufacturer:

INNOVEX MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastro-urological guidewire, single-use

Manufacturer:

INNOVEX MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urethral dilatation catheter, non-medicated

Manufacturer:

INNOVEX MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urethral dilatation catheter, non-medicated

Manufacturer:

INNOVEX MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multidisciplinary medical image management software

Manufacturer:

Intelerad Holdings USA Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

Intelerad Medical Systems Incorporated

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acetabular orthopaedic reamer

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone-resection orthopaedic reamer, single-use

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Chisel/osteotome blade handle

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant-instrument extension adaptor, reusable

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant/instrument assembling device

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

GenMark Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

GenMark Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)

Manufacturer:

GenMark Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)

Manufacturer:

GenMark Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trisomy 21-risk hormone IVD, control

Manufacturer:

SERO AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human genomic analysis interpretive software

Manufacturer:

Omixon Biocomputing Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Manufacturer:

Zeptometrix

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MRSA nucleic acid IVD, control

Manufacturer:

Zeptometrix

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MRSA/MSSA nucleic acid IVD, control

Manufacturer:

Zeptometrix

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus nucleic acid IVD, control

Manufacturer:

Zeptometrix

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Norovirus nucleic acid IVD, control

Manufacturer:

Zeptometrix

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) nucleic acid IVD, control

Manufacturer:

Zeptometrix

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trichomonas vaginalis nucleic acid IVD, control

Manufacturer:

Zeptometrix

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Zeus Scientific, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Zeus Scientific, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella virus antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Zeus Scientific, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Zeus Scientific, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Zeus Scientific, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Arthroscopic irrigation/insufflation system

Manufacturer:

HEMODIA SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Central venous catheterization kit, short-term

Manufacturer:

HEMODIA SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General surgical procedure kit, non-medicated, single-use

Manufacturer:

HEMODIA SAS

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Haemodialysis start/stop set

Manufacturer:

HEMODIA SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket, metal

Manufacturer:

Hespeler Orthodontics Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic power arm/lock

Manufacturer:

Hespeler Orthodontics Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic tube

Manufacturer:

Hespeler Orthodontics Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Aripiprazole therapeutic drug monitoring IVD, reagent

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Busulfan therapeutic drug monitoring IVD, control

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Imatinib therapeutic drug monitoring IVD, control

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Imatinib therapeutic drug monitoring IVD, reagent

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Olanzapine therapeutic drug monitoring IVD, reagent

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Paclitaxel therapeutic drug monitoring IVD, control

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer-related multiple gene mutation profile kit IVD

Manufacturer:

Biocartis NV

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Biocartis NV

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

KRAS gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Biocartis NV

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Biocartis NV

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Biocartis NV

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bare-metal intracranial vascular stent

Manufacturer:

phenox GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral vascular guidewire extension

Manufacturer:

phenox GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Coagulation factor IX IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Affinity Biologicals Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Affinity Biologicals Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mass spectrometry analyser IVD, automated

Manufacturer:

Agena Bioscience

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

1,3-Beta-D-glucan IVD, kit, enzyme spectrophotometry

Manufacturer:

Associates of Cape Cod, Incorporated

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pregabalin IVD, calibrator

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fentanyl IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ketamine/ketamine metabolite IVD, calibrator

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methotrexate therapeutic drug monitoring IVD, calibrator

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neurontin (gabapentin) IVD, calibrator

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pethidine IVD, calibrator

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pethidine IVD, control

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pethidine IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pregabalin IVD, control

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, control

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tramadol IVD, calibrator

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tramadol IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Voriconazole therapeutic drug monitoring IVD, calibrator

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Voriconazole therapeutic drug monitoring IVD, reagent

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose/haemoglobin (Hb) IVD, control

Manufacturer:

Canterbury Scientific Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Precision System Science Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Magnetic particle separation instrument IVD

Manufacturer:

Precision System Science Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Omixon Biocomputing Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, control

Manufacturer:

SERO AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis nucleic acid IVD, control

Manufacturer:

Zeptometrix

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A/B virus nucleic acid IVD, control

Manufacturer:

Zeptometrix

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, control

Manufacturer:

Zeptometrix

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Borrelia burgdorferi antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Zeus Scientific, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Michel?s solution IVD

Manufacturer:

Zeus Scientific, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae antigen/antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Zeus Scientific, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-cell malignancy IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Adaptive Biotechnologies Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Azure Biosystems, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethyl glucuronide (EtG) IVD, calibrator

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fentanyl IVD, control

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gabapentin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ketamine/ketamine metabolite IVD, control

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Levetiracetam therapeutic drug monitoring IVD, control

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methotrexate therapeutic drug monitoring IVD, control

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neurontin (gabapentin) IVD, control

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, calibrator

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, control

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Voriconazole therapeutic drug monitoring IVD, control

Manufacturer:

ARK Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser control unit IVD

Manufacturer:

Caliber Imaging and Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple haemoglobin subtype IVD, calibrator

Manufacturer:

Canterbury Scientific Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple haemoglobin subtype IVD, control

Manufacturer:

Canterbury Scientific Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Orthopaedic chisel blade

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic instrument extractor

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, reusable

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical depth gauge, reusable

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

HPF S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medication transfer set

Manufacturer:

Huayi Isotopes Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tap, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive point, single-use

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental mirror, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental surgical scissors

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diamond dental bur, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held dental retractor

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual endodontic file/rasp, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual non-rotary dental instrument handle

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Metal/carbide ENT bur, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Periodontal curette

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical mallet

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Hager & Meisinger GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood refrigerator/freezer

Manufacturer:

Helmer Scientific DBA Helmer Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Platelet incubator

Manufacturer:

Helmer Scientific DBA Helmer Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical mains power cable

Manufacturer:

HEMODIA SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

HEMODIA SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis start/stop set

Manufacturer:

HEMODIA SAS

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Orthodontic archwire

Manufacturer:

Hespeler Orthodontics Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic archwire protection sleeve

Manufacturer:

Hespeler Orthodontics Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic pliers

Manufacturer:

Hespeler Orthodontics Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

5-Fluorouracil (5-FU) therapeutic drug monitoring IVD, control

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Aripiprazole therapeutic drug monitoring IVD, reagent

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Busulfan therapeutic drug monitoring IVD, reagent

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Paclitaxel therapeutic drug monitoring IVD, reagent

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Risperidone therapeutic drug monitoring IVD, reagent

Manufacturer:

Saladax Biomedical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Compression/pressure sock/stocking, single-use

Manufacturer:

Carolon

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression material adhesive

Manufacturer:

CB Dental Materials GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microsatellite instability IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Biocartis NV

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bare-metal intracranial vascular stent

Manufacturer:

phenox GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thrombectomy wire-net

Manufacturer:

phenox GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bite registration rim wax, plate

Manufacturer:

Great Lakes Dental Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray, reusable

Manufacturer:

Great Lakes Dental Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

GX Corporation Sdn Bhd (Specialty Plant)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vertebral bone filler, non-bioabsorbable

Manufacturer:

OSARTIS GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Osteonic Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tendon/ligament bone anchor, non-bioabsorbable

Manufacturer:

Osteonic Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infant feeding bottle nipple, single-use

Manufacturer:

CAIR LGL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device disinfection agent

Manufacturer:

CAIR LGL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasogastric/orogastric tube

Manufacturer:

CAIR LGL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vulnerable patient home-monitoring software, layperson-use

Manufacturer:

Otiom A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure kit

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implantable-device cutter

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, reusable

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental soft-tissue coring punch, single-use

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

Paltop Advanced Dental Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

Paragon Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal implant trial

Manufacturer:

Paradigm Spine GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microarray analyser IVD

Manufacturer:

NanoString Technologies Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mechanical micropipette IVD

Manufacturer:

Nichiryo Co Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Activated clotting time (ACT) IVD, kit, clotting

Manufacturer:

Pentapharm AG

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Activated protein C resistance ratio (APCR) IVD, kit, clotting

Manufacturer:

Pentapharm AG

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Pearl Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Manufacturer:

Premier Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Activated partial thromboplastin time (APTT) IVD, control

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor IX IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor V IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VII IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII inhibitor IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII inhibitor IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor XI IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lupus anticoagulant marker IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lupus anticoagulant marker IVD, reagent

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, calibrator

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, calibrator

Manufacturer:

Precision BioLogic Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electrocardiographic ambulatory recorder

Manufacturer:

iRhythm Technologies, Inc

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer

Manufacturer:

Streck Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Full blood count IVD, calibrator

Manufacturer:

Streck Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Streck Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid amplification mastermix kit IVD

Manufacturer:

Streck Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Streck Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sperm concentration indicator IVD, control

Manufacturer:

Streck Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Magnetic particle separation instrument IVD

Manufacturer:

T2 Biosystems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple bloodstream bacteria nucleic acid IVD, control

Manufacturer:

T2 Biosystems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Osmolality IVD, reagent

Manufacturer:

Trukera Medical

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Osmometric analyser IVD

Manufacturer:

Trukera Medical

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General-purpose syringe, single-use

Manufacturer:

Inari Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suture retention device

Manufacturer:

Inari Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thrombectomy wire-net introduction set

Manufacturer:

Inari Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Capillary blood collection tube IVD, no additive

Manufacturer:

Vitrex Medical a/s

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Examination/treatment table, line-powered

Manufacturer:

Pivotal Health Solutions, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Traction table, manual

Manufacturer:

Pivotal Health Solutions, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, reusable

Manufacturer:

Pixee Medical

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Surgical camera holder

Manufacturer:

Pixee Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-parameter urinary monitoring system connection set

Manufacturer:

Potrero Medical, Inc. dba Accuryn Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biopsy gun handpiece

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone marrow biopsy needle, single-use

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound/centesis drainage receptacle

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravascular extraction catheter-snare

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Needle guide, single-use

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Needle guide, single-use

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nephrostomy catheter

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Robotic electrosurgical instrument, monopolar, reusable

Manufacturer:

Asensus Surgical Italia S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Robotic surgical system

Manufacturer:

Asensus Surgical Italia S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adrenal antibody IVD, reagent

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD, manual

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Double stranded DNA antibody (anti-dsDNA) IVD, reagent

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glomerular basement membrane antibody (Goodpasture antibody) IVD, reagent

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Islet cell antibody IVD, kit, fluorescent immunoassay

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide coverslip IVD

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple neurological disease-associated antibody IVD, kit, fluorescent immunoassay

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myelin-associated glycoprotein antibody (anti-MAG) IVD, fluorescent immunoassay

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Negative control immunoglobulin IVD

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Yo antibody IVD, control

Manufacturer:

IMMCO Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

HOB Biotech Group Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay signal generation kit IVD

Manufacturer:

HOB Biotech Group Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Intrinsic factor/parietal cell antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

HOB Biotech Group Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoperfusion system absorption column

Manufacturer:

CytoSorbents Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental coating, tooth-desensitizing, professional

Manufacturer:

Dental Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental etching solution

Manufacturer:

Dental Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentifrice

Manufacturer:

Dental Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentine bonding agent/set

Manufacturer:

Dental Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic temporary cement

Manufacturer:

Dental Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fatty acid dental cement

Manufacturer:

Dental Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glass ionomer dental cement

Manufacturer:

Dental Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant abutment analog, scanning

Manufacturer:

Dentalpoint AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant analog

Manufacturer:

Dentalpoint AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis/implant abutment screw analog, single-use

Manufacturer:

Dentalpoint AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MSH2 antigen IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MSH6 antigen IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MUM1 transcription factor IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Muscle-specific alpha/gamma actin IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycobacterium tuberculosis immunoglobulin G (IgG) antibody IVD, reagent

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neurofilament protein IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

p16 antigen IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

p501s IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

p53 tumour protein IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

p63 tumour protein IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pepsin IVD, reagent

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phosphatase and tensin homolog (PTEN) protein IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Polymer-enzyme conjugate IVD, reagent

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Postmeiotic segregation increased 2 (PMS2) IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pressurized incubator IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Programmed death-1 (PD-1) IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Proliferating cell nuclear antigen (PCNA) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Proto-oncogene tyrosine-protein kinase ROS (ROS1) IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Signal transducer and activator of transcription (STAT) protein IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SMAD4 protein IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Smoothelin IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SOXC protein IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SOXE protein IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Specimen preparation enzyme reagent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Synaptophysin IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid transcription factor-1 (TTF1) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trypsin IVD, reagent

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tumour-associated glycoprotein-72 (TAG72) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Wilms tumour protein IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Loupe

Manufacturer:

Designs for Vision, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

DIROS TECHNOLOGY INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

DIROS TECHNOLOGY INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical return electrode, single-use

Manufacturer:

DIROS TECHNOLOGY INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous radio-frequency ablation probe cannula, reusable

Manufacturer:

DIROS TECHNOLOGY INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use

Manufacturer:

DIROS TECHNOLOGY INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous radio-frequency ablation system generator

Manufacturer:

DIROS TECHNOLOGY INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft contact lens inserter/remover

Manufacturer:

DMV Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Examination/treatment table, line-powered

Manufacturer:

Dornier MedTech GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General/multiple surgical solid-state laser system

Manufacturer:

Dornier MedTech GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical image management system

Manufacturer:

Dornier MedTech GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bite registration rim wax

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, thermoplastic

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Denture reliner, hard

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic appliance cleanser

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic appliance positioning tray

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Silicone dental impression material

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Absorbent wound compression pad

Manufacturer:

Dupaco Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood transfusion set, non-exchange

Manufacturer:

Amsino International Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device-irrigation sterile saline solution

Manufacturer:

Amsino International Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental chair, electric

Manufacturer:

Antoni Carles S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic chair, line-powered

Manufacturer:

Antoni Carles S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Static ophthalmic equipment stand, manually-adjusted

Manufacturer:

Antoni Carles S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Static ophthalmic equipment stand, manually-adjusted

Manufacturer:

Antoni Carles S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye patch

Manufacturer:

Apothecary Products, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lice comb, manual

Manufacturer:

Apothecary Products, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal aspirator, manual

Manufacturer:

Apothecary Products, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical handpiece, single-use

Manufacturer:

Apyx Medical Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive powder

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive powder

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental articulation paste/solution

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument rinsing agent

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device cleaning agent

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device cleaning/disinfection wipe

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device disinfection agent

Manufacturer:

PRISMAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous pole

Manufacturer:

Pryor Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose absorbent tip applicator/swab, single-use

Manufacturer:

Puritan Medical Products Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device sterilization/disinfection container, reusable

Manufacturer:

7D Surgical ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose stereotactic surgery system

Manufacturer:

7D Surgical ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

7D Surgical ULC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infusion pump cassette

Manufacturer:

Abiomed, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intracardiac circulatory assist axial-pump catheter

Manufacturer:

Abiomed, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intracardiac circulatory assist axial-pump catheter

Manufacturer:

Abiomed, Inc.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Cardiac radio-frequency ablation system catheter

Manufacturer:

Access Point Technologies EP Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Access Point Technologies EP Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile medical equipment stand, electrically-powered

Manufacturer:

Accuvein Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile medical equipment stand, non-powered

Manufacturer:

Accuvein Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Kinesiology ambulatory recorder

Manufacturer:

ActiGraph LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mattress repair patch

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment drape, single-use

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table mattress, basic

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiation therapy bolus, reusable

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiation therapy bolus, single-use

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair seat cushion

Manufacturer:

Action Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiation therapy software

Manufacturer:

Adaptiiv Medical Technologies Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Craniofacial fixation plate, non-bioabsorbable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Drilling power tool attachment, basic

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, single-use

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General internal orthopaedic fixation system implantation kit

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone washer, non-sterile

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic fixation plate bending insert, reusable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant/instrument assembling device

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant/instrument assembling device

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implantation sleeve, reusable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical countersink, reusable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical depth gauge, reusable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Upper-limb traction wrap/trap, single-use, sterile

Manufacturer:

Acumed LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Portable computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Amyloid P component IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anaplastic lymphoma kinase IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Arginase IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Breast carcinoma antigen 225 (BCA-225) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calcitonin IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calponin protein IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 125 (CA125) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD11c cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD20 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD21 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD22 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD235a glycophorin A red blood cell marker IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD33 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD56 neural cell adhesion molecule-1 (NCAM-1) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD71 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD99 cell marker IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cox-2 IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytokeratin IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytokeratin IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D2-40 antigen IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Desmin protein IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Desmoglein 3 (DSG3) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Detergent solution IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epidermal growth factor receptor (EGFR) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epithelial membrane antigen (EMA) IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Estrogen (oestrogen)/progesterone receptor IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucagon IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Heat shock protein IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Histone protein IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry antigen retrieval reagent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry conjugated secondary antibody IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry endogenous protein blocking reagent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry negative control (normal animal serum) IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry protease reagent IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin-like growth factor II mRNA binding protein 3 (IMP3) IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ki67 antigen IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

LIM-domain-only (LMO) protein IVD, antibody

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mammaglobin IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Melanosome IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide maker/digital imaging analyser IVD

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Androstenedione IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fasciola hepatica total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Leptin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasmin-alpha-2-antiplasmin complex (PAP) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Renin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Soluble transferrin receptor IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Strongyloides stercoralis immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cortisol IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total testosterone IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DRG Instruments GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Future Diagnostics Solutions B.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytological centrifuge funnel IVD

Manufacturer:

Simport Scientific Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, kit, nephelometry/turbidimetry

Manufacturer:

Gentian AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Retinol binding protein IVD, kit, nephelometry/turbidimetry

Manufacturer:

Gentian AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII inhibitor IVD, control

Manufacturer:

George King Bio-Medical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor XIII A subunit IVD, control

Manufacturer:

George King Bio-Medical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Autoinjector needle

Manufacturer:

CHIRANA T.Injecta, a. s.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENFit oral/enteral syringe, single-use

Manufacturer:

CHIRANA T.Injecta, a. s.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hypodermic needle, single-use

Manufacturer:

CHIRANA T.Injecta, a. s.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electric cooling fan

Manufacturer:

Clarius Mobile Health Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held ultrasound imaging system, body-surface

Manufacturer:

Clarius Mobile Health Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, single-use

Manufacturer:

ClearPoint Neuro Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intracerebral cannula, nonimplantable, single-use

Manufacturer:

ClearPoint Neuro Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skull clamp

Manufacturer:

ClearPoint Neuro Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot-switch, electrical

Manufacturer:

Iridex Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General/multiple surgical diode laser system

Manufacturer:

Iridex Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General/multiple surgical frequency-doubled solid-state laser system

Manufacturer:

Iridex Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laser adaptor

Manufacturer:

Iridex Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic diode laser system

Manufacturer:

Iridex Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

ivWatch, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous access site infiltration/extravasation monitoring system sensor

Manufacturer:

ivWatch, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous access site monitoring system fibreoptic cable holder

Manufacturer:

ivWatch, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Myoelectric forequarter-amputation prosthesis

Manufacturer:

Coapt, LLC

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Myoelectric forequarter-amputation prosthesis

Manufacturer:

Coapt, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Myoelectric forequarter-amputation prosthesis

Manufacturer:

Coapt, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External lower-limb prosthesis structural/alignment component

Manufacturer:

College Park Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hydraulic/pneumatic external ankle-foot prosthesis

Manufacturer:

College Park Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hydraulic/pneumatic external knee prosthesis

Manufacturer:

College Park Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hydraulic/pneumatic external knee prosthesis

Manufacturer:

College Park Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical-resistance external ankle-foot prosthesis

Manufacturer:

College Park Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical-resistance external knee prosthesis

Manufacturer:

College Park Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Passive shoulder prosthesis

Manufacturer:

College Park Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental casting non-noble alloy

Manufacturer:

Amann Girrbach AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental wrought alloy

Manufacturer:

Amann Girrbach AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Facebow

Manufacturer:

Amann Girrbach AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body-surface ultrasound imaging transducer cover

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body-surface ultrasound imaging transducer cover

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical tip cleaning pad

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Finger-cot surgical drape

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment handle cover, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel handle, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Umbilical cord clamp, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Umbilical cord clamp, single-use

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular booties

Manufacturer:

Aspen Surgical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Catheter/overtube balloon inflator, single-use

Manufacturer:

Atrion Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electric pad whole-body heating system

Manufacturer:

Augustine Temperature Management, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing/utility forceps, tweezers-like, reusable

Manufacturer:

Avalign Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

Avalign Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medullary canal orthopaedic reamer, flexible

Manufacturer:

Avalign Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal implant trial

Manufacturer:

Avalign Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/emergency suction cannula, non-illuminating, reusable

Manufacturer:

Avalign Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material heater

Manufacturer:

Inter-Med, Inc.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Medical equipment handle cover, single-use, non-sterile

Manufacturer:

Inter-Med, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Root canal irrigation blunt needle

Manufacturer:

Inter-Med, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medication transfer needle, non-filtering/non-vented

Manufacturer:

International Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical suction system Y-piece valve-connector

Manufacturer:

INTERSCOPE, INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue morcellation system control unit

Manufacturer:

INTERSCOPE, INC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, reusable

Manufacturer:

ELOS Medtech Pinol A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

ELOS Medtech Pinol A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device air compressor

Manufacturer:

EndoClot Plus Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-organic haemostatic agent

Manufacturer:

EndoClot Plus Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Submucosal lift solution

Manufacturer:

EndoClot Plus Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Custom-made mouthguard

Manufacturer:

EnvisionTEC GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental occlusal splint, custom-made

Manufacturer:

EnvisionTEC GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resin artificial teeth

Manufacturer:

EnvisionTEC GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Silicone gel-filled breast implant, smooth-surface

Manufacturer:

Establishment Labs S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Silicone gel-filled breast implant, textured-surface

Manufacturer:

Establishment Labs S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Self-retaining surgical retractor, reusable

Manufacturer:

Etablissements OURY-GUYE et Fils

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Euroteknika

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

Euroteknika

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, skin

Manufacturer:

Exergen Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound-nonadherent dressing, absorbent, antimicrobial

Manufacturer:

Ferris Mfg. Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Depth electrode

Manufacturer:

FHC, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Depth electrode

Manufacturer:

FHC, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intracerebral cannula, nonimplantable, reusable

Manufacturer:

FHC, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurological stereotactic surgery system

Manufacturer:

FHC, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurosurgical micro targeting drive

Manufacturer:

FHC, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurosurgical procedure kit, non-medicated, single-use

Manufacturer:

FHC, Inc

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Dental casting wax

Manufacturer:

FKG Dentaire Sàrl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic broach, serrated, single-use

Manufacturer:

FKG Dentaire Sàrl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual endodontic file/rasp, reusable

Manufacturer:

FKG Dentaire Sàrl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual endodontic file/rasp, single-use

Manufacturer:

FKG Dentaire Sàrl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotary/reciprocating endodontic file/rasp, reusable

Manufacturer:

FKG Dentaire Sàrl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic broach, serrated, single-use

Manufacturer:

FKG Dentaire SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic enlarger, reusable

Manufacturer:

FKG Dentaire SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual endodontic filling material spreader

Manufacturer:

FKG Dentaire SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotary/reciprocating endodontic file/rasp, single-use

Manufacturer:

FKG Dentaire SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray, single-use

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket, ceramic

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic clasp, metal, preformed

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic inter-arch elastic band

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic inter-bracket elastic chain

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic spring

Manufacturer:

FlexMedics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Penile sexual vibrator

Manufacturer:

Joylux, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sexual lubricant

Manufacturer:

Joylux, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary x-ray grid

Manufacturer:

JPI Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope video camera

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic procedure air/water valve, reusable

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fibreoptic light cable

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Light source adaptor

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid endoscopic scissors, reusable

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid optical cystoscope

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid optical cystoscope

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid optical hysteroscope

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid optical laparoscope

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid optical nephroscope

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid video laparoscope

Manufacturer:

Schölly Fiberoptic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Footrest

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General examination/treatment chair, electric

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Head/neck immobilizer, single-use

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical table restraint anchor

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic knee/leg holder liner

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical counter-traction post

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Universal operating table top

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis/implant abutment screw

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steel dental bur, reusable

Manufacturer:

SDS Swiss Dental Solutions AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Veracyte Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cervical total intervertebral disc prosthesis, modular

Manufacturer:

SIGNUS Medizintechnick GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, reusable

Manufacturer:

SIGNUS Medizintechnick GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vertebral body prosthesis

Manufacturer:

SIGNUS Medizintechnick GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Prescription spectacles

Manufacturer:

SightGlass Vision, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound-nonadherent dressing, permeable, non-antimicrobial

Manufacturer:

Sion Biotext Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow stabilization implant

Manufacturer:

Skeletal Dynamics, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical ruler, reusable

Manufacturer:

Skeletal Dynamics, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw (non-sliding)

Manufacturer:

Skeletal Dynamics, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

SprintRay Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

SprintRay Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple spinal region orthosis

Manufacturer:

SPIO, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wrist/hand orthosis

Manufacturer:

SPIO, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal applicator, single-use

Manufacturer:

SRC Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal applicator, single-use

Manufacturer:

SRC Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haematological cell analyser IVD

Manufacturer:

Drucker Diagnostics, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inhalational analgesia unit

Manufacturer:

Medical Developments International Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External orthopaedic fixation system, single-use

Manufacturer:

Medicalplastic s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone wire

Manufacturer:

Medicalplastic s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Externally-anchored laparoscopic retractor

Manufacturer:

Mediflex Surgical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument assist arm system, manually-adjusted

Manufacturer:

Mediflex Surgical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical retraction system, reusable

Manufacturer:

Mediflex Surgical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental surgical probe, reusable

Manufacturer:

B&L Biotech, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental ultrasonic surgical system

Manufacturer:

B&L Biotech, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Periodontal probe, reusable

Manufacturer:

B&L Biotech, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic intravenous administration set, noninvasive

Manufacturer:

MedSafety Solutions

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

Ray Co.,Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental computed radiography digital imaging scanner

Manufacturer:

Ray Co.,Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary panoramic/tomographic dental x-ray system, digital

Manufacturer:

Ray Co.,Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Brachytherapy needle

Manufacturer:

Riverpoint Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lacrimal punctum plug

Manufacturer:

Riverpoint Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nylon suture, non-bioabsorbable, monofilament

Manufacturer:

Riverpoint Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Manufacturer:

Riverpoint Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Frame/rail/pole device holder

Manufacturer:

Kyra Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental caries detecting stain

Manufacturer:

Kuraray Noritake Dental Inc. Kurashiki

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

Kuraray Noritake Dental Inc. Kurashiki

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

Kuraray Noritake Dental Inc. Kurashiki

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin kit

Manufacturer:

Kuraray Noritake Dental Inc. Kurashiki

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material injection cannula, single-use

Manufacturer:

Kuraray Noritake Dental Inc. Kurashiki

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material mixing nozzle

Manufacturer:

Kuraray Noritake Dental Inc. Kurashiki

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis priming agent

Manufacturer:

Kuraray Noritake Dental Inc. Kurashiki

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arm procedure positioner, reusable

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument transport trolley system

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose diagnostic imaging table

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical clip rack

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow/ankle friction/impact protector

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electromechanical operating table base

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Freestanding headrest, reusable

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose medical foam padding, single-use

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heel stirrup cushion/pad

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Leg procedure positioner

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Leg procedure positioner

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical table clamp

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical table top floor stand

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table orthopaedic extension

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table patient pressure distribution pad, reusable

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table traction frame

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic operating table top

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic operating table, electromechanical

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient transfer sliding board

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal surgery positioning board

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stretcher mattress

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical linen/cushion set

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Universal operating table top

Manufacturer:

Mizuho OSI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medullary canal orthopaedic reamer, flexible

Manufacturer:

MPS Micro Precision Systems AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic guidewire, reusable

Manufacturer:

MPS Micro Precision Systems AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arterial tourniquet, manual, single-use

Manufacturer:

SAM Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Emergency junctional haemorrhage compression set

Manufacturer:

SAM Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pelvic fracture binder, single-use

Manufacturer:

SAM Medical Products

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scar management dressing, single-use, non-sterile

Manufacturer:

Scar Heal

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood bank information system application software

Manufacturer:

SCC Soft Computer

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mastication muscle exerciser

Manufacturer:

SCHEU-DENTAL GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material injection cannula, single-use

Manufacturer:

Schottlander Manufacturing GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood lancet, single-use

Manufacturer:

SteriLance Medical(Suzhou) Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual blood lancing device, single-use

Manufacturer:

SteriLance Medical(Suzhou) Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-cleaning wipe, non-sterile

Manufacturer:

SteriLance Medical(Suzhou) Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose absorbent tip applicator/swab, single-use

Manufacturer:

SteriPack USA Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External circulating-fluid core temperature regulation system control unit, heating/cooling

Manufacturer:

Belmont Medical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Extravascular-circulation hyperthermia system applicator, intracorporeal

Manufacturer:

Belmont Medical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Extravascular-circulation hyperthermia system applicator, intracorporeal

Manufacturer:

Belmont Medical Technologies

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dynamic visual acuity testing system

Manufacturer:

Bertec Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dynamic visual acuity testing system

Manufacturer:

Bertec Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posturography system platform

Manufacturer:

Bertec Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bedside infusion pump, single-channel

Manufacturer:

Stockert GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bedside infusion pump, single-channel

Manufacturer:

Stockert GmbH

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Cardiac ablation system irrigation tubing set

Manufacturer:

Stockert GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac radio-frequency ablation system generator

Manufacturer:

Stockert GmbH

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Diagnostic peripheral nerve electrical stimulation system

Manufacturer:

Stockert GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing needle, single-use

Manufacturer:

Lincotek Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyester suture, non-bioabsorbable, multifilament

Manufacturer:

LSI SOLUTIONS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument assist arm system structural component

Manufacturer:

LSI SOLUTIONS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument assist arm system, manually-adjusted

Manufacturer:

LSI SOLUTIONS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing unit, single-use

Manufacturer:

LSI SOLUTIONS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mindfulness/behavioural therapy software, non-clinician-consultative

Manufacturer:

Mahana Therapeutics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye patch

Manufacturer:

Marketlab Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flat panel x-ray detector/film cassette weight-bearing protector

Manufacturer:

Marketlab Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oxygen/air breathing gas mixer, hospital

Manufacturer:

Maxtec, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Respiratory oxygen monitor, battery-powered

Manufacturer:

Maxtec, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Respiratory oxygen sensor

Manufacturer:

Maxtec, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

MD Orthopaedics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive air jet system handpiece

Manufacturer:

Mectron S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental ultrasonic surgical system

Manufacturer:

Mectron S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental ultrasonic surgical system handpiece tip

Manufacturer:

Mectron S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental ultrasonic surgical system handpiece tip

Manufacturer:

Mectron S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/surgical polymerization lamp

Manufacturer:

Mectron S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, reusable

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, reusable

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material mixing surface, chairside, single-use

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental mould

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket adhesive

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket adhesive

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic inter-arch elastic band

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic inter-arch elastic band

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultraviolet view box

Manufacturer:

Reliance Orthodontic Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatoscope, optical

Manufacturer:

MetaOptima Technology Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid arthroscope, reusable

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sawing power tool attachment, oscillating

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sawing power tool attachment, sagittal

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument guard, reusable

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Battery box

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone file/rasp, reciprocating, single-use

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone/joint surgical power tool motorized handpiece/set, pneumatic

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Burring power tool attachment

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device sterilization/disinfection container, reusable

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liposuction system cannula, reusable

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liposuction system cannula, single-use

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose surgical power tool system, line-powered

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, oscillating, single-use

Manufacturer:

MicroAire Surgical Instruments, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Mighty Oak Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, single-use

Manufacturer:

Mighty Oak Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical planning/navigation-enhancement system

Manufacturer:

X-Nav Technologies, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical planning/navigation-enhancement system

Manufacturer:

X-Nav Technologies, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Inflatable patient transfer sliding mattress, single-use

Manufacturer:

Xodus Medical Inc.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Operating table non-slip back pad

Manufacturer:

Xodus Medical Inc.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Negative-pressure intravenous line needleless valve-connector

Manufacturer:

Yukon Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neutral-pressure intravenous line needleless valve-connector

Manufacturer:

Yukon Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube speech valve

Manufacturer:

Freudenberg Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic appliance relief material

Manufacturer:

G and H Wire Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic archwire

Manufacturer:

G and H Wire Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic archwire/bracket ligature

Manufacturer:

G and H Wire Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket, ceramic

Manufacturer:

G and H Wire Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket, metal

Manufacturer:

G and H Wire Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic clasp, metal, preformed

Manufacturer:

G and H Wire Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic extraoral headgear

Manufacturer:

G and H Wire Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic inter-bracket elastic chain

Manufacturer:

G and H Wire Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic separator

Manufacturer:

G and H Wire Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic spring

Manufacturer:

G and H Wire Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Chongqing Keysmile Biological Technology Co., Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Single-channel clinical chemistry analyser IVD, point-of-care

Manufacturer:

Chongqing Keysmile Biological Technology Co., Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Conduction blood/fluid warmer set

Manufacturer:

Ace Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermal curette

Manufacturer:

ACUDERM, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-approximation adhesive

Manufacturer:

Adhezion Biomedical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wearable percutaneous catheter/tube holder

Manufacturer:

Adhezion Biomedical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vitreous/aqueous humour replacement medium, intraoperative

Manufacturer:

ALFA INSTRUMENTS S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Contact lens wetting solution

Manufacturer:

AVIZOR S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye lubricant

Manufacturer:

AVIZOR S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose soft contact lens solution

Manufacturer:

AVIZOR S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Angiography kit

Manufacturer:

Angiodroid SpA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing unit, single-use

Manufacturer:

Apollo Endosurgery, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haematological concentrate system preparation kit, platelet concentration

Manufacturer:

Arteriocyte Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Deep-tissue electromagnetic stimulation system, home-use

Manufacturer:

ASA s.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Core temperature regulation orogastric tube

Manufacturer:

Attune Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin photodynamic therapy lamp

Manufacturer:

Biofrontera Pharma GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft contact lens cleaning solution

Manufacturer:

AVIZOR S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac valvuloplasty catheter

Manufacturer:

Balt Extrusion SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac/peripheral vascular guidewire, single-use

Manufacturer:

Balt Extrusion SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral angioplasty balloon catheter, basic

Manufacturer:

Balt Extrusion SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular guide-catheter, single-use

Manufacturer:

Balt Extrusion SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological image marker, implantable

Manufacturer:

Best Medical International, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hot/cold therapy pack, reusable

Manufacturer:

Bio Compression Systems, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

Brasseler USA Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bur, single-use

Manufacturer:

Brasseler USA Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, oscillating, single-use

Manufacturer:

Brasseler USA Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bronchial balloon catheter

Manufacturer:

Broncus Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible endoscopic biopsy handpiece/needle

Manufacturer:

Broncus Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lung biopsy procedure kit

Manufacturer:

Broncus Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Localized oedema electrical impedance scanner

Manufacturer:

Bruin Biometrics LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical gas flowmeter, Thorpe tube

Manufacturer:

Caire Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held ultrasound imaging system, body-surface

Manufacturer:

Butterfly Network, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac ablation solid-state laser system

Manufacturer:

CARDIOFOCUS INC

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

Cercare Medical A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held multi-spectral vascular imaging device

Manufacturer:

Christie Medical Holdings, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation pump

Manufacturer:

Chongqing Jinshan Science& Technology (Group) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video capsule endoscopy monitoring kit

Manufacturer:

Chongqing Jinshan Science& Technology (Group) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video capsule endoscopy system capsule magnetic manipulation unit

Manufacturer:

Chongqing Jinshan Science& Technology (Group) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acupuncture needle, single-use

Manufacturer:

Eunsung Global Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cryogenic spray, cutaneous

Manufacturer:

CryoConcepts, LP

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cosmetic micro-needling electronic handpiece cartridge, professional

Manufacturer:

Crown Aesthetics

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mixed-respiratory-gas low pressure hose

Manufacturer:

DEHAS Medical Systems GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Portable liquid oxygen unit

Manufacturer:

DEHAS Medical Systems GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Human papillomavirus (HPV) nucleic acid IVD, kit, microarray

Manufacturer:

ZytoVision GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Nucleic acid hybridization detection IVD, kit

Manufacturer:

ZytoVision GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Ewing?s sarcoma IVD, probe

Manufacturer:

ZytoVision GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Her2/neu/erbB2 gene mutation IVD, probe

Manufacturer:

ZytoVision GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Nucleic acid hybridization detection IVD, probe

Manufacturer:

ZytoVision GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Phosphatase and tensin homolog (PTEN) gene IVD, probe

Manufacturer:

ZytoVision GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Dental instrument depth limiter

Manufacturer:

Dentalpoint AG

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Manufacturer:

Skeletal Dynamics, Inc

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Nucleic acid amplification mastermix reagent IVD

Manufacturer:

ZytoVision GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Oligodendroglioma loss of heterozygosity (LOH) IVD, probe

Manufacturer:

ZytoVision GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe

Manufacturer:

ZytoVision GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Chromogenic/colorimetric substrate reagent IVD

Manufacturer:

ZytoVision GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Cyclin D1 genetic mutation IVD, probe

Manufacturer:

ZytoVision GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, probe

Manufacturer:

ZytoVision GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Elbow crutch

Manufacturer:

Mobility Designed, Inc.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Rigid endoscopic scissors, single-use

Manufacturer:

Modern Medical Equipment Manufacturing Ltd.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Electrosurgical handpiece, single-use

Manufacturer:

Modern Medical Equipment Manufacturing Ltd.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Manufacturer:

Modern Medical Equipment Manufacturing Ltd.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Manufacturer:

Modern Medical Equipment Manufacturing Ltd.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Cardiopulmonary bypass system heat exchanger, reusable

Manufacturer:

Quest Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Vaginal speculum, single-use

Manufacturer:

OBP Medical Corporation DBA OBP Medical

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Surgical/emergency suction cannula, non-illuminating, single-use

Manufacturer:

OBP Medical Corporation DBA OBP Medical

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

Manufacturer:

Modern Medical Equipment Manufacturing Ltd.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Open-surgery electrosurgical electrode, monopolar, single-use

Manufacturer:

Modern Medical Equipment Manufacturing Ltd.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

General-purpose surgical suction system, electric

Manufacturer:

Modern Medical Equipment Manufacturing Ltd.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Electrical-only medical device connection cable, single-use

Manufacturer:

Modern Medical Equipment Manufacturing Ltd.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Infusion/injection port/tack applicator

Manufacturer:

ReShape Lifesciences

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Surgical/emergency suction cannula, illuminating, single-use

Manufacturer:

OBP Medical Corporation DBA OBP Medical

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Laryngoscope blade, single-use

Manufacturer:

OBP Medical Corporation DBA OBP Medical

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Hand-held surgical retractor, single-use

Manufacturer:

OBP Medical Corporation DBA OBP Medical

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Subcutaneous infusion/injection port needle

Manufacturer:

ReShape Lifesciences

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Gastric calibration tube

Manufacturer:

ReShape Lifesciences

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Radiation therapy software

Manufacturer:

Adaptiiv Medical Technologies Inc.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Anoscope, single-use

Manufacturer:

OBP Medical Corporation DBA OBP Medical

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Total cholesterol lipid IVD, kit, rapid colorimetric, self-testing

Manufacturer:

Visgeneer Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 10, 2024

Ketone (acetoacetate) IVD, reagent

Manufacturer:

Visgeneer Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 10, 2024

Glucose monitoring system IVD, home-use

Manufacturer:

Visgeneer Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 10, 2024

Uric acid monitoring system IVD, home-use

Manufacturer:

Visgeneer Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 10, 2024

MRI system coil, radio-frequency

Manufacturer:

Quality Electrodynamics, LLC

Type:

General Medical Device

Registration Date:

Nov 10, 2024

MRI system coil, radio-frequency

Manufacturer:

Quality Electrodynamics, LLC

Type:

General Medical Device

Registration Date:

Nov 10, 2024

Dental casting non-noble alloy

Manufacturer:

Eisenbacher Dentalwaren ED GmbH

Type:

General Medical Device

Registration Date:

Nov 10, 2024

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 10, 2024

Electroencephalographic signal amplifier

Manufacturer:

Corscience GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 10, 2024

Custom-made dental crown, polymer

Manufacturer:

Eisenbacher Dentalwaren ED GmbH

Type:

General Medical Device

Registration Date:

Nov 10, 2024

Custom-made dental crown, polymer

Manufacturer:

Eisenbacher Dentalwaren ED GmbH

Type:

General Medical Device

Registration Date:

Nov 10, 2024

Closed-wound drain connector

Manufacturer:

Argon Medical Devices Inc.

Type:

General Medical Device

Registration Date:

Nov 10, 2024

Bone nail guidewire, reusable

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Nov 10, 2024

Vascular microcatheter

Manufacturer:

Balt USA, LLC

Type:

System or Procedure Pack

Registration Date:

Nov 4, 2024

Thrombectomy suction catheter

Manufacturer:

Balt USA, LLC

Type:

General Medical Device

Registration Date:

Nov 4, 2024

Vascular microcatheter

Manufacturer:

Balt USA, LLC

Type:

General Medical Device

Registration Date:

Nov 4, 2024

Metallic spinal interbody fusion cage

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Sharp surgical instrument counting tray/pad, single-use

Manufacturer:

Xodus Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Bone-screw internal spinal fixation system, non-sterile

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Spinal fixation plate, non-bioabsorbable

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Intraoperative orthopaedic bone pin/screw, single-use

Manufacturer:

Brasseler USA Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Orthopaedic bone wire

Manufacturer:

Brasseler USA Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Multi-parameter urinary monitoring system control unit

Manufacturer:

Potrero Medical, Inc. dba Accuryn Medical

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Metallic spinal interbody fusion cage

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Metallic spinal interbody fusion cage

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Orthopaedic bone wire

Manufacturer:

Brasseler USA Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Bone-screw internal spinal fixation system, non-sterile

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Bone-screw internal spinal fixation system, non-sterile

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Bone-screw internal spinal fixation system, sterile

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Internal spinal fixation procedure kit, reusable

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Multi-parameter urinary monitoring system connection set

Manufacturer:

Potrero Medical, Inc. dba Accuryn Medical

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Internal spinal fixation procedure kit, reusable

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Metallic spinal interbody fusion cage

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Intraoperative orthopaedic bone pin/screw, single-use

Manufacturer:

Brasseler USA Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Blue-light phototherapy lamp, professional

Manufacturer:

Jeisys Medical Inc

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Emesis bag

Manufacturer:

Xodus Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Endoscope antifog solution

Manufacturer:

Xodus Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Internal spinal fixation procedure kit, reusable

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Instrument tray, reusable

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Growth-correction orthopaedic fixation plate kit

Manufacturer:

Orthofix US LLC

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Gingival retraction solution

Manufacturer:

Inter-Med, Inc.

Type:

General Medical Device

Registration Date:

Oct 27, 2024

Dentine bonding agent/set

Manufacturer:

Inter-Med, Inc.

Type:

General Medical Device

Registration Date:

Oct 27, 2024

Dental etching solution

Manufacturer:

Inter-Med, Inc.

Type:

General Medical Device

Registration Date:

Oct 27, 2024

Radiology DICOM image processing application software

Manufacturer:

Densitas Inc.

Type:

General Medical Device

Registration Date:

Oct 27, 2024

General-purpose syringe, single-use

Manufacturer:

AEA srl

Type:

General Medical Device

Registration Date:

Oct 27, 2024

General-purpose syringe, single-use

Manufacturer:

AEA srl

Type:

General Medical Device

Registration Date:

Oct 27, 2024

General-purpose syringe, single-use

Manufacturer:

AEA srl

Type:

General Medical Device

Registration Date:

Oct 27, 2024

Noninvasive vascular ultrasound system probe

Manufacturer:

Compumedics Germany GmbH

Type:

General Medical Device

Registration Date:

Oct 27, 2024

Ophthalmic ultrasound imaging system

Manufacturer:

DGH Technology, Inc.

Type:

General Medical Device

Registration Date:

Oct 27, 2024

Dental prosthesis-component adhesive

Manufacturer:

Inter-Med, Inc.

Type:

General Medical Device

Registration Date:

Oct 27, 2024

Root canal cleaning solution

Manufacturer:

Inter-Med, Inc.

Type:

General Medical Device

Registration Date:

Oct 27, 2024

Intravascular near-infrared spectroscopy imaging system

Manufacturer:

Infraredx, Inc.

Type:

General Medical Device

Registration Date:

Oct 27, 2024

Dental prosthesis priming agent

Manufacturer:

Inter-Med, Inc.

Type:

General Medical Device

Registration Date:

Oct 27, 2024

Intravascular near-infrared spectroscopy imaging system catheter

Manufacturer:

Infraredx, Inc.

Type:

General Medical Device

Registration Date:

Oct 27, 2024

Invasive vascular ultrasound system probe

Manufacturer:

Compumedics Germany GmbH

Type:

General Medical Device

Registration Date:

Oct 27, 2024

Noninvasive vascular ultrasound system, line-powered

Manufacturer:

Compumedics Germany GmbH

Type:

General Medical Device

Registration Date:

Oct 27, 2024

Endoscopic electrosurgical mucosal biopsy/resection set

Manufacturer:

Intelligent Endoscopy LLC

Type:

General Medical Device

Registration Date:

Oct 27, 2024

Intraoperative ultrasound imaging transducer cover

Manufacturer:

Protek Medical Product, Inc.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Assistive scooter, electric-motor-driven

Manufacturer:

Heartway Medical Products Co., Ltd.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Body-surface ultrasound imaging transducer cover

Manufacturer:

Protek Medical Product, Inc.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Finger-cot surgical drape

Manufacturer:

Protek Medical Product, Inc.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Needle guide, single-use

Manufacturer:

Protek Medical Product, Inc.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Intradermal radio-frequency ablation system

Manufacturer:

ILOODA

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Wheelchair, power-assisted, occupant-controlled, collapsible

Manufacturer:

Heartway Medical Products Co., Ltd.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Needle guide, reusable

Manufacturer:

Protek Medical Product, Inc.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Medical equipment drape, single-use

Manufacturer:

Protek Medical Product, Inc.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Needle guide, single-use

Manufacturer:

Protek Medical Product, Inc.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Body-surface ultrasound imaging transducer cover

Manufacturer:

Protek Medical Product, Inc.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Dermatological carbon dioxide laser system

Manufacturer:

ILOODA

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Dermatological diode laser system

Manufacturer:

ILOODA

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Intradermal radio-frequency ablation system needle electrode

Manufacturer:

ILOODA

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Electric-motor-driven wheelchair, occupant-controlled

Manufacturer:

Heartway Medical Products Co., Ltd.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Wheelchair, power-assisted, occupant-controlled, non-collapsible

Manufacturer:

Heartway Medical Products Co., Ltd.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Body-orifice ultrasound imaging transducer cover, basic, non-sterile

Manufacturer:

Protek Medical Product, Inc.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Finger-cot surgical drape

Manufacturer:

Protek Medical Product, Inc.

Type:

General Medical Device

Registration Date:

Oct 21, 2024

Electrosurgical system generator

Manufacturer:

Bolder Surgical

Type:

General Medical Device

Registration Date:

Oct 9, 2024

Craniofacial bone screw, non-bioabsorbable, non-sterile

Manufacturer:

X-Nav Technologies, LLC

Type:

General Medical Device

Registration Date:

Oct 9, 2024

Surgical planning/navigation-enhancement system

Manufacturer:

X-Nav Technologies, LLC

Type:

General Medical Device

Registration Date:

Oct 9, 2024

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

Manufacturer:

Bolder Surgical

Type:

General Medical Device

Registration Date:

Oct 9, 2024

Intravascular near-infrared spectroscopy imaging system

Manufacturer:

Infraredx, Inc.

Type:

General Medical Device

Registration Date:

Oct 9, 2024

Gastro-urological guidewire, single-use

Manufacturer:

PIOLAX MEDICAL DEVICES, INC.

Type:

General Medical Device

Registration Date:

Oct 9, 2024

Peripheral vascular guidewire, manual

Manufacturer:

PIOLAX MEDICAL DEVICES, INC.

Type:

General Medical Device

Registration Date:

Oct 9, 2024

Peripheral vascular intervention infusion catheter

Manufacturer:

PIOLAX MEDICAL DEVICES, INC.

Type:

General Medical Device

Registration Date:

Oct 9, 2024

Intravascular near-infrared spectroscopy imaging system catheter

Manufacturer:

Infraredx, Inc.

Type:

General Medical Device

Registration Date:

Oct 9, 2024

Portosystemic needle set

Manufacturer:

Creganna Medical

Type:

General Medical Device

Registration Date:

Oct 4, 2024

Vascular guide-catheter, single-use

Manufacturer:

Creganna Medical

Type:

General Medical Device

Registration Date:

Oct 4, 2024

Coronary angioplasty balloon catheter, basic

Manufacturer:

Creganna Medical

Type:

General Medical Device

Registration Date:

Oct 4, 2024

Vortex oxygen face mask

Manufacturer:

Southmedic Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Vortex oxygen face mask

Manufacturer:

Southmedic Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Vortex oxygen face mask

Manufacturer:

Southmedic Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Breathing circuit gas-sampling/monitoring set

Manufacturer:

Southmedic Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

General-gas low pressure tubing, reusable

Manufacturer:

Southmedic Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Breathing circuit gas-sampling/monitoring set

Manufacturer:

Southmedic Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Open-surgery dissector

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Neurosurgical probe

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Dental coating, bond-reduction

Manufacturer:

Bisco, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Tracheostomy tube speech valve

Manufacturer:

Passy-Muir, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Cardiac/peripheral vascular guidewire, single-use

Manufacturer:

Lake Region Medical Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Multichannel clinical chemistry analyser IVD, point-of-care, line-powered

Manufacturer:

Trukera Medical

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical retraction system mounting frame, reusable

Manufacturer:

Bradshaw Medical Inc. (dba Intech)

Type:

System or Procedure Pack

Registration Date:

Sep 24, 2024

Spinal rongeur

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Multiple-type clinical chemistry analyte profile IVD, reagent

Manufacturer:

Trukera Medical

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

General-purpose surgical scissors, reusable

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Sep 24, 2024

General surgical procedure kit, non-medicated, reusable

Manufacturer:

Laboratoires Bodycad, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Unicondylar knee prosthesis

Manufacturer:

Laboratoires Bodycad, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

General-purpose curette

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Vortex oxygen face mask

Manufacturer:

Southmedic Inc.

Type:

System or Procedure Pack

Registration Date:

Sep 24, 2024

Surgical soft-tissue manipulation forceps, scissors-like, reusable

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Suturing needle holder, reusable

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Scalpel, reusable

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Manufacturer:

Laboratoires Bodycad, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Electrocardiographic ambulatory recorder

Manufacturer:

iRhythm Technologies, Inc

Type:

System or Procedure Pack

Registration Date:

Sep 23, 2024

Radiological PACS software

Manufacturer:

inHEART

Type:

General Medical Device

Registration Date:

Sep 8, 2024

Image segmentation application software

Manufacturer:

inHEART

Type:

General Medical Device

Registration Date:

Sep 8, 2024

Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

TECHLAB, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

TECHLAB, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Lactoferrin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

TECHLAB, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

TECHLAB, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Clostridium perfringens enterotoxin antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

TECHLAB, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

TECHLAB, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Lactoferrin IVD, kit, rapid ICT, clinical

Manufacturer:

TECHLAB, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Multiple Campylobacter species antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

TECHLAB, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Saccharomyces cerevisiae total antibody IVD, kit enzyme immunoassay (EIA)

Manufacturer:

TECHLAB, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Cryptosporidium species antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

TECHLAB, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Clostridium difficile antigen IVD, kit, cell culture assay

Manufacturer:

TECHLAB, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

TECHLAB, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

TECHLAB, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Orthopaedic surgical procedure kit, non-medicated, single-use

Manufacturer:

Nextremity Solutions, Inc.

Type:

General Medical Device

Registration Date:

Aug 11, 2024

Multi-parameter urinary monitoring system catheter set

Manufacturer:

Potrero Medical, Inc.

Type:

General Medical Device

Registration Date:

Aug 11, 2024

Multi-parameter urinary monitoring system connection set

Manufacturer:

Potrero Medical, Inc.

Type:

General Medical Device

Registration Date:

Aug 11, 2024

Home-use magnetic neural stimulator

Manufacturer:

eNeura, Inc.

Type:

General Medical Device

Registration Date:

Aug 11, 2024

Cardiac electrophysiology processing software

Manufacturer:

Cardiologs Technologies

Type:

General Medical Device

Registration Date:

Jul 29, 2024

CT system application software

Manufacturer:

Elucid Bioimaging Inc

Type:

General Medical Device

Registration Date:

Jul 22, 2024

Multiple colorectal cancer risk-associated protein marker IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Rhythm Biosciences Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 22, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Soft corrective contact lens, daily-disposable

Manufacturer:

St. Shine Optical Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Image display unit, colour

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Portable computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Portable computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Soft corrective contact lens, daily-wear

Manufacturer:

St. Shine Optical Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Portable computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Portable computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Panel computer

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Image display unit, colour

Manufacturer:

Advantech Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Endoscopic insufflation tubing set, single-use

Manufacturer:

Insightra Medical, INC

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Rigid optical arthroscope, reusable

Manufacturer:

Insightra Medical, INC

Type:

General Medical Device

Registration Date:

Jul 9, 2024

Percutaneous radio-frequency ablation system generator

Manufacturer:

STARmed CO LTD

Type:

General Medical Device

Registration Date:

Jul 8, 2024

Flexible endoscopic biopsy handpiece/needle

Manufacturer:

STARmed CO LTD

Type:

General Medical Device

Registration Date:

Jul 8, 2024

Endoscopic electrosurgical electrode, bipolar, single-use

Manufacturer:

STARmed CO LTD

Type:

General Medical Device

Registration Date:

Jul 8, 2024

Spinal muscular atrophy (SMA) IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Asuragen, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 8, 2024

Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Asuragen, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 8, 2024

Huntington's disease IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Asuragen, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 8, 2024

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Asuragen, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 8, 2024

Endoscopic electrosurgical electrode, monopolar, single-use

Manufacturer:

STARmed CO LTD

Type:

General Medical Device

Registration Date:

Jul 8, 2024

Fragile X syndrome IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Asuragen, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 8, 2024

Programmable ambulation exoskeleton, home-use

Manufacturer:

Parker Hannifin Human Motion & Control

Type:

General Medical Device

Registration Date:

Jul 8, 2024

Blue/red/infrared phototherapy lamp

Manufacturer:

Foshan Gaunying Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 8, 2024

Benchtop nebulizer, non-heated

Manufacturer:

Foshan Gaunying Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 8, 2024

Indwelling urethral drainage balloon catheter, non-antimicrobial

Manufacturer:

Continence Care ApS

Type:

General Medical Device

Registration Date:

Jul 8, 2024

Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar

Manufacturer:

STARmed CO LTD

Type:

General Medical Device

Registration Date:

Jul 8, 2024

Hypodermic needle, single-use

Manufacturer:

SteriPack Medical Poland Sp. z o.o.

Type:

General Medical Device

Registration Date:

Jul 8, 2024

Myotonic dystrophy IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Asuragen, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 8, 2024

General specimen container IVD, additive/medium

Manufacturer:

Asuragen, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 8, 2024

Programmable ambulation exoskeleton, clinical

Manufacturer:

Parker Hannifin Human Motion & Control

Type:

General Medical Device

Registration Date:

Jul 8, 2024

Dental waterline disinfectant cartridge

Manufacturer:

Sterisil, Inc

Type:

General Medical Device

Registration Date:

Jul 7, 2024

Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

Manufacturer:

STARmed CO LTD

Type:

General Medical Device

Registration Date:

Jul 7, 2024

Ultrasonic dental scaling/debridement system

Manufacturer:

E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 7, 2024

Dental amalgam mixer

Manufacturer:

E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 7, 2024

Dental abrasive air jet system handpiece

Manufacturer:

E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd.

Type:

General Medical Device

Registration Date:

Jul 7, 2024

Benchtop nebulizer, heated

Manufacturer:

Storz & Bickel GmbH

Type:

General Medical Device

Registration Date:

Jul 4, 2024

Oral/respiratory tract specimen container IVD, additive/medium

Manufacturer:

DNA Genotek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jun 24, 2024

Oral/upper respiratory tract specimen collection swab

Manufacturer:

DNA Genotek Inc.

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Oral/upper respiratory tract specimen collection swab

Manufacturer:

DNA Genotek Inc.

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Faecal specimen container IVD, DNA preservation solution

Manufacturer:

DNA Genotek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jun 24, 2024

Wearable multiple physiological parameter recorder, reusable

Manufacturer:

AVA Sciences - FMTC LLC

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Oral/upper respiratory tract specimen collection swab

Manufacturer:

DNA Genotek Inc.

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Oral/respiratory tract specimen container IVD, additive/medium

Manufacturer:

DNA Genotek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jun 24, 2024

Oral/respiratory tract specimen container IVD, additive/medium

Manufacturer:

DNA Genotek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jun 24, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

DNA Genotek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jun 24, 2024

Radiological PACS software

Manufacturer:

LUMEDX Corporation

Type:

General Medical Device

Registration Date:

Jun 10, 2024

Cardiology information system application software

Manufacturer:

LUMEDX Corporation

Type:

General Medical Device

Registration Date:

Jun 10, 2024

Alternating-pressure bed mattress

Manufacturer:

Airflo (Xiamen) Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Jun 10, 2024

Alternating-pressure pump

Manufacturer:

Airflo (Xiamen) Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Jun 10, 2024

Alternating-pressure chair cushion system

Manufacturer:

Airflo (Xiamen) Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Jun 10, 2024

Alternating-pressure bed mattress system

Manufacturer:

Airflo (Xiamen) Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Jun 10, 2024

Dermal curette

Manufacturer:

Aesthetic Group

Type:

General Medical Device

Registration Date:

Jun 3, 2024

Skin-coring punch, single-use

Manufacturer:

Aesthetic Group

Type:

General Medical Device

Registration Date:

Jun 3, 2024

Tissue injection cannula

Manufacturer:

Aesthetic Group

Type:

General Medical Device

Registration Date:

Jun 3, 2024

Liposuction system cannula, single-use

Manufacturer:

Aesthetic Group

Type:

General Medical Device

Registration Date:

Jun 3, 2024

Assisted reproduction procedure dish

Manufacturer:

Corning Incorporated

Type:

General Medical Device

Registration Date:

Jun 3, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Japan Lifeline Co., Ltd.

Type:

General Medical Device

Registration Date:

May 9, 2024

Cardiac mapping catheter, percutaneous, single-use

Manufacturer:

Japan Lifeline Co., Ltd.

Type:

General Medical Device

Registration Date:

May 9, 2024

Autologous adipose tissue collection/injection set

Manufacturer:

BSL Co., Ltd

Type:

General Medical Device

Registration Date:

May 9, 2024

Dermatological solid-state laser system

Manufacturer:

Quanta System Spa

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Cardioversion switchbox

Manufacturer:

Visco Technology Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Apheresis system

Manufacturer:

Otsuka Electronics Co.,Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Lung donor-organ preservation/evaluation system

Manufacturer:

XVIVO Perfusion AB

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Donor-organ/tissue/cell preservation solution

Manufacturer:

XVIVO Perfusion AB

Type:

General Medical Device

Registration Date:

Apr 11, 2024

General/multiple surgical diode laser system

Manufacturer:

Quanta System Spa

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Kidney donor-organ preservation/transport perfusion set

Manufacturer:

XVIVO B.V.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Electrosurgical system

Manufacturer:

XO CARE A/S

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Autologous adipose tissue collection/injection set

Manufacturer:

Thiebaud SAS

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Body aspiration needle, single-use

Manufacturer:

Thiebaud SAS

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Rigid-gas-permeable corrective contact lens, daily-wear

Manufacturer:

Woehlk Contactlinsen GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Skin electrical conductance meter

Manufacturer:

Withings

Type:

General Medical Device

Registration Date:

Apr 11, 2024

General/multiple surgical solid-state laser system

Manufacturer:

Quanta System Spa

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Tissue morcellation system handpiece, battery-powered

Manufacturer:

Quanta System Spa

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Absorbent underpad, non-antimicrobial, single-use

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Adult nappy

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Liposuction system cannula, single-use

Manufacturer:

Thiebaud SAS

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Urogenital surgical laser system beam guide, single-use

Manufacturer:

Quanta System Spa

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Incontinence pants liner

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Adult nappy

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Incontinence pants liner

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Intravascular near-infrared spectroscopy imaging system catheter

Manufacturer:

Infraredx, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

General/multiple surgical solid-state laser system

Manufacturer:

Quanta System Spa

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Urogenital surgical laser system beam guide, reusable

Manufacturer:

Quanta System Spa

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Urogenital surgical laser system beam guide, reusable

Manufacturer:

Quanta System Spa

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Urogenital surgical laser system beam guide, single-use

Manufacturer:

Quanta System Spa

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Tissue injection cannula

Manufacturer:

Thiebaud SAS

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Angiographic catheter, single-use

Manufacturer:

Togo Medikit Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Incontinence pants, single-use

Manufacturer:

Ontex BV

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Capillary blood collection kit, home-use

Manufacturer:

Tasso, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Urogenital surgical laser system beam guide, reusable

Manufacturer:

Quanta System Spa

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Intense pulsed light skin surface treatment system

Manufacturer:

Quanta System Spa

Type:

General Medical Device

Registration Date:

Apr 11, 2024

General/multiple surgical diode/carbon dioxide laser system

Manufacturer:

Quanta System Spa

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Dermatological frequency-doubled solid-state laser system

Manufacturer:

Quanta System Spa

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Haemodialysis needle

Manufacturer:

Togo Medikit Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Vascular catheter introduction set, nonimplantable

Manufacturer:

Togo Medikit Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Surgical retractor/retraction system blade, reusable

Manufacturer:

Thompson Surgical Instruments, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Hypodermic needle, single-use

Manufacturer:

TSK Laboratory, Japan

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Needle guide, single-use

Manufacturer:

TSK Laboratory, Japan

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Intermittent electronic patient thermometer

Manufacturer:

UEBE Medical GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Cardiac electrophysiology application software

Manufacturer:

VectraCor Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Thermal vapour lung treatment system generator

Manufacturer:

Uptake Medical B.V.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Electrocardiograph, professional, multichannel

Manufacturer:

VectraCor Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Soft corrective contact lens, daily-wear

Manufacturer:

Visco Technology Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Clamp jaw cover

Manufacturer:

Vitalitec International, Inc. d/b/a Peters Surgical USA

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Hybrid corrective contact lens, non-customized

Manufacturer:

SynergEyes, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Capillary blood collection kit, home-use

Manufacturer:

Tasso, Inc.

Type:

System or Procedure Pack

Registration Date:

Apr 11, 2024

Manual blood lancing device, single-use

Manufacturer:

Tasso, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Activated-medium surgical warming blanket

Manufacturer:

TechTrade LLC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Electrocardiography telemetric monitoring system

Manufacturer:

Wellysis Corp.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Subcutaneous self-injection aid

Manufacturer:

West Pharmaceutical Services AZ, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Soft corrective contact lens, daily-wear

Manufacturer:

Yung Sheng Optical Co., Ltd

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Scalpel, single-use

Manufacturer:

YourBio Health, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Lung donor-organ preservation/evaluation system lung-interface set

Manufacturer:

XVIVO Perfusion AB

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Liver donor-organ preservation/transport system

Manufacturer:

XVIVO B.V.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Kidney donor-organ preservation/transport system

Manufacturer:

XVIVO B.V.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Dental delivery system

Manufacturer:

XO CARE A/S

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Dental x-ray film, non-screen

Manufacturer:

Wolf X-ray Corp. dba Flow Dental

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Soft corrective contact lens, daily-wear

Manufacturer:

Woehlk Contactlinsen GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Wearable multiple physiological parameter recorder, reusable

Manufacturer:

Withings

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Withings

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Multiple vital physiological parameter monitoring system, clinical

Manufacturer:

VivaLNK, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Intravascular anastomosis occluder

Manufacturer:

Vitalitec International, Inc. d/b/a Peters Surgical USA

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Soft corrective contact lens, daily-disposable

Manufacturer:

Visioneering Technologies, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Soft corrective contact lens, daily-disposable

Manufacturer:

Visco Technology Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Retinal image analysis software

Manufacturer:

Verily Life Sciences LLC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Diagnostic spirometer, professional

Manufacturer:

VectraCor Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Pneumatic massager

Manufacturer:

usMIMA, S.L.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Warm-bonded endodontic obturation system obturator

Manufacturer:

US Endodontics, LLC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Soft corrective contact lens, daily-wear

Manufacturer:

UNICON OPTICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Soft corrective contact lens, daily-disposable

Manufacturer:

UNICON OPTICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Tissue injection cannula

Manufacturer:

TSK Laboratory, Japan

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Side-notch biopsy gun handpiece/needle

Manufacturer:

TSK Laboratory, Japan

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Hypodermic needle, single-use

Manufacturer:

TSK Laboratory, Japan

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Bone marrow biopsy needle, single-use

Manufacturer:

TSK Laboratory, Japan

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Peripheral vascular intervention infusion catheter

Manufacturer:

Togo Medikit Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Haemodialysis needle

Manufacturer:

Togo Medikit Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Surgical retraction system, reusable

Manufacturer:

Thompson Surgical Instruments, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Surgical retraction system, reusable

Manufacturer:

Thompson Surgical Instruments, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Instrument tray, reusable

Manufacturer:

Thompson Surgical Instruments, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Radiology DICOM image processing application software

Manufacturer:

Terarecon, Inc

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Soft corrective contact lens, daily-wear

Manufacturer:

Woehlk Contactlinsen GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Faecal occult blood immunoassay analyser IVD

Manufacturer:

Otsuka Electronics Co.,Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Intravascular near-infrared spectroscopy imaging system

Manufacturer:

Infraredx, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Kidney donor-organ preservation/transport system

Manufacturer:

XVIVO B.V.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Sleep disorder interpretive software, patient-use

Manufacturer:

Withings

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Cardiac electrophysiology application software

Manufacturer:

Withings

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Continuous electronic patient thermometer, battery-powered

Manufacturer:

VivaLNK, Inc.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Surgical bulldog clamp, single-use

Manufacturer:

Vitalitec International, Inc. d/b/a Peters Surgical USA

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Soft corrective contact lens, daily-wear

Manufacturer:

Visco Technology Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Soft corrective contact lens, daily-disposable

Manufacturer:

Visco Technology Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Soft corrective contact lens, daily-disposable

Manufacturer:

Yung Sheng Optical Co., Ltd

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Multi-purpose soft contact lens solution

Manufacturer:

Yung Sheng Optical Co., Ltd

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Lung donor-organ preservation/evaluation system lung-interface set

Manufacturer:

XVIVO Perfusion AB

Type:

System or Procedure Pack

Registration Date:

Apr 11, 2024

Cardiac electrophysiology application software

Manufacturer:

Withings

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Thermal vapour lung treatment system catheter

Manufacturer:

Uptake Medical B.V.

Type:

General Medical Device

Registration Date:

Feb 23, 2024

Flexible endoscopic scissors, single-use

Manufacturer:

Slater Endoscopy, LLC

Type:

General Medical Device

Registration Date:

Feb 23, 2024

Orthopaedic bone bolt

Manufacturer:

Medicalplastic s.r.l.

Type:

General Medical Device

Registration Date:

Apr 6, 2023

Medical gas flowmeter, Thorpe tube

Manufacturer:

TECHNOLOGIE MEDICALE

Type:

General Medical Device

Registration Date:

Mar 30, 2023

Alternating-pressure bed mattress overlay system

Manufacturer:

Dabir Surfaces, Inc.

Type:

General Medical Device

Registration Date:

Jan 31, 2023

Alternating-pressure bed mattress overlay system

Manufacturer:

Dabir Surfaces, Inc.

Type:

General Medical Device

Registration Date:

Jan 31, 2023

Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Exosome Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 28, 2022

Head/neck procedure positioner

Manufacturer:

Schuremed

Type:

General Medical Device

Registration Date:

Jul 22, 2022

Orthodontic inter-bracket elastic chain

Manufacturer:

RMO Europe SAS

Type:

General Medical Device

Registration Date:

Jul 12, 2022

Orthodontic archwire/bracket ligature

Manufacturer:

RMO Europe SAS

Type:

General Medical Device

Registration Date:

Jul 12, 2022

Orthodontic inter-arch elastic band

Manufacturer:

RMO Europe SAS

Type:

General Medical Device

Registration Date:

Jul 12, 2022

Multiple solid tumour differentiation marker IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Proteomedix AG

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 1, 2022

Electrosurgical return lead

Manufacturer:

KLS Martin GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Apr 12, 2022

Electrosurgical system generator

Manufacturer:

KLS Martin GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Apr 12, 2022

Operating table accessory trolley

Manufacturer:

KLS Martin GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Apr 12, 2022

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Manufacturer:

KLS Martin GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Apr 12, 2022

Open-surgery electrosurgical electrode, monopolar, single-use

Manufacturer:

KLS Martin GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Apr 12, 2022

Foot-switch, electrical

Manufacturer:

KLS Martin GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Apr 12, 2022

Inert gas-enhanced electrosurgical system generator

Manufacturer:

KLS Martin GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Apr 12, 2022

Inert gas-enhanced electrosurgical cable

Manufacturer:

KLS Martin GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Apr 12, 2022

Surgical plume evacuation system

Manufacturer:

KLS Martin GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Apr 12, 2022

Nail infection solution

Manufacturer:

Moberg Pharma AB

Type:

General Medical Device

Registration Date:

Apr 8, 2022

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system external electrode

Manufacturer:

Stimwave Technologies Incorporated

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Apr 5, 2022

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wireless connection

Manufacturer:

Stimwave Technologies Incorporated

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Apr 5, 2022

Personal device holder, reusable

Manufacturer:

Stimwave Technologies Incorporated

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Apr 5, 2022

Noninvasive device battery charger

Manufacturer:

Stimwave Technologies Incorporated

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Apr 5, 2022

Neurosurgical procedure kit, non-medicated, single-use

Manufacturer:

Stimwave Technologies Incorporated

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Apr 5, 2022

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, extracorporeal

Manufacturer:

Stimwave Technologies Incorporated

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Apr 5, 2022

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer

Manufacturer:

Stimwave Technologies Incorporated

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Apr 5, 2022

Soft-tissue/mesh anchor, non-bioabsorbable

Manufacturer:

Stimwave Technologies Incorporated

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Apr 5, 2022

Gastrointestinal/biliary dilation balloon catheter

Manufacturer:

Hobbs Medical, Inc.

Type:

General Medical Device

Registration Date:

Mar 8, 2022

Ventricular prosthesis system

Manufacturer:

SynCardia Systems, LLC

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Jan 31, 2022

Total human chorionic gonadotropin (HCG) IVD, reagent

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Troponin I IVD, reagent

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Multiple traumatic brain injury marker IVD, kit, enzyme immunoassay (EIA), rapid

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Prothrombin time (PT) IVD, reagent

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Prothrombin time (PT) IVD, control

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Multiple traumatic brain injury marker IVD, control

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Human chorionic gonadotropin beta-core fragment IVD, control

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Troponin I IVD, control

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Creatine kinase myocardial isoenzyme (CKMB) IVD, control

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Activated clotting time (ACT) IVD, control

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Creatinine/ammonium electrode IVD

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Activated clotting time (ACT) IVD, kit, clotting

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, reagent

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered

Manufacturer:

Abbott Point of Care

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 28, 2022

Bedside physiologic monitoring software

Manufacturer:

AirStrip Technologies, Inc.

Type:

General Medical Device

Registration Date:

Jan 24, 2022

Self-retaining surgical retractor, single-use

Manufacturer:

Swemac Innovation AB

Type:

General Medical Device

Registration Date:

Jan 7, 2022

Neonatal/paediatric heart rate monitoring application software

Manufacturer:

Medical Predictive Science Corporation

Type:

General Medical Device

Registration Date:

Jan 5, 2022

Metered-delivery hypodermic syringe

Manufacturer:

Muzamal Industries Sdn Bhd

Type:

General Medical Device

Registration Date:

Jan 4, 2022

Metered-delivery hypodermic syringe

Manufacturer:

Muzamal Industries Sdn Bhd

Type:

General Medical Device

Registration Date:

Jan 4, 2022

Hypodermic needle, single-use

Manufacturer:

Muzamal Industries Sdn Bhd

Type:

General Medical Device

Registration Date:

Jan 4, 2022

HLA-DR antigen tissue typing IVD, kit, enzyme immunohistochemistry

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 30, 2021

HIV1/HIV2/Mycobacterium tuberculosis antibody IVD, reagent

Manufacturer:

Biocare Medical, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 30, 2021

Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Biocartis NV

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 28, 2021

Cancer associated serum antigen (CASA) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Rhythm Biosciences Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 22, 2021

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Dec 21, 2021

Surgical vessel loop

Manufacturer:

Telic, S.A.U.

Type:

General Medical Device

Registration Date:

Dec 21, 2021

Vision self-testing software

Manufacturer:

Vital Art and Science, LLC

Type:

General Medical Device

Registration Date:

Dec 16, 2021

Orthodontic retainer

Manufacturer:

Access Dental Lab, LLC

Type:

General Medical Device

Registration Date:

Nov 30, 2021

Silicone dental impression material

Manufacturer:

Access Dental Lab, LLC

Type:

General Medical Device

Registration Date:

Nov 30, 2021

Silicone dental impression material

Manufacturer:

Access Dental Lab, LLC

Type:

System or Procedure Pack

Registration Date:

Nov 30, 2021

Dental cheek retractor, home-use

Manufacturer:

Access Dental Lab, LLC

Type:

General Medical Device

Registration Date:

Nov 30, 2021

Dental impression tray, single-use

Manufacturer:

Access Dental Lab, LLC

Type:

General Medical Device

Registration Date:

Nov 30, 2021

Orthodontic progressive aligner

Manufacturer:

Access Dental Lab, LLC

Type:

General Medical Device

Registration Date:

Nov 30, 2021

Biological fluid specimen collection cartridge IVD

Manufacturer:

Neoteryx LLC, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 16, 2021

Endoscopic overtube, single-use

Manufacturer:

Apollo Endosurgery, Inc.

Type:

General Medical Device

Registration Date:

Nov 10, 2021

Suturing unit, single-use

Manufacturer:

Apollo Endosurgery, Inc.

Type:

General Medical Device

Registration Date:

Nov 10, 2021

Appetite-suppression gastric balloon

Manufacturer:

Apollo Endosurgery, Inc.

Type:

General Medical Device

Registration Date:

Nov 10, 2021

Mental health/function therapeutic software, screen-viewed

Manufacturer:

GAIA AG

Type:

General Medical Device

Registration Date:

Nov 4, 2021

Mindfulness/behavioural therapy software, non-clinician-consultative

Manufacturer:

GAIA AG

Type:

General Medical Device

Registration Date:

Nov 4, 2021

Electrocardiography telemetric monitoring system

Manufacturer:

Corscience GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 3, 2021

Burn gel

Manufacturer:

Aurena Laboratories AB

Type:

General Medical Device

Registration Date:

Oct 28, 2021

Urethral measuring catheter

Manufacturer:

SRS Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Oct 28, 2021

Multi-purpose therapeutic saline solution

Manufacturer:

Aurena Laboratories AB

Type:

General Medical Device

Registration Date:

Oct 28, 2021

Multi-purpose therapeutic saline solution

Manufacturer:

Aurena Laboratories AB

Type:

General Medical Device

Registration Date:

Oct 28, 2021

Kinesiology/electromyographic sensor set

Manufacturer:

SRS Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Oct 28, 2021

Polymeric urethral stent, short-term

Manufacturer:

SRS Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Oct 28, 2021

Patient medical adhesive remover

Manufacturer:

Aurena Laboratories AB

Type:

General Medical Device

Registration Date:

Oct 28, 2021

Bone marrow biopsy needle, single-use

Manufacturer:

Ranfac Corporation

Type:

General Medical Device

Registration Date:

Oct 20, 2021

Suturing unit, single-use

Manufacturer:

Ranfac Corporation

Type:

General Medical Device

Registration Date:

Oct 20, 2021

Bone access cannula

Manufacturer:

Ranfac Corporation

Type:

General Medical Device

Registration Date:

Oct 20, 2021

Laparoscopic blunt dissector

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Laparoscopic blunt dissector

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Limb/torso/head restraint, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Negative-pressure wound therapy system dressing set

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Negative-pressure wound therapy system foam dressing, non-antimicrobial

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Open-surgery electrosurgical electrode, monopolar, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Ophthalmic sponge

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Sharp surgical instrument counting tray/pad, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Skin marking pen, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Surgical instrument containment holder, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Surgical plume evacuation system

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Surgical suction system collection container, reusable

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Umbilical cord clamp, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Umbilical cord clamp/cutter

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Knee support orthosis

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Insufflation gas conditioning tubing set

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

General-purpose surgical sponge

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

General-purpose surgical sponge

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Wound-nonadherent dressing, permeable, non-antimicrobial

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Angiographic syringe

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Angiography kit

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Arm immobilizer

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Electrical-only medical device connection cable, reusable

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

General-purpose patient temperature probe, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Lumbar cushion

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Medical equipment handle cover, single-use, sterile

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Needle guide, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Pressure bandage, non-latex, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Suction system canister liner

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Surgical instrument containment holder, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Surgical vessel loop

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Temperature-monitoring indwelling urethral drainage catheter

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Towel clamp, reusable

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Wound-nonadherent dressing, permeable, antimicrobial

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

General-purpose patient temperature probe, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

General-purpose bowl, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Endoscopic antifog solution

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Electrosurgical tip cleaning pad

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Electrosurgical system

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Dry medical towel/wipe, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Blood pressure cuff, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Adhesive bandage

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Adhesive bandage

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Angiographic syringe

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Electronic oesophageal stethoscope, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Electrosurgical system

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Freestanding headrest, reusable

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Freestanding patient positioner, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

General-purpose patient temperature probe, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Insufflation gas conditioning tubing set

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Medical equipment handle cover, single-use, sterile

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Medicine cup, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Open-surgery electrosurgical electrode, monopolar, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Pressure bandage, non-latex, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Sharp surgical instrument counting tray/pad, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Skin marking pen, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Skin treatment/dressing-supportive limb/finger bandage, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Spring-loaded pneumoperitoneum needle, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Surgical drape clip

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Surgical plume evacuation system

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Surgical suction system collection container, single-use

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Vascular booties

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Vascular booties

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Wound-nonadherent dressing, absorbent, non-antimicrobial

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Wound-nonadherent dressing, absorbent, non-antimicrobial

Manufacturer:

DeRoyal Industries, Inc.

Type:

General Medical Device

Registration Date:

Sep 27, 2021

Transcutaneous electrical stimulation electrode, reusable

Manufacturer:

HTK Enterprises, Inc. dba InterX Technologies

Type:

General Medical Device

Registration Date:

Sep 23, 2021

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

HTK Enterprises, Inc. dba InterX Technologies

Type:

General Medical Device

Registration Date:

Sep 23, 2021

Radiology DICOM image processing application software

Manufacturer:

Nano-X AI Ltd.

Type:

General Medical Device

Registration Date:

Sep 23, 2021

Radiology DICOM image processing application software

Manufacturer:

Nano-X AI Ltd.

Type:

General Medical Device

Registration Date:

Sep 23, 2021

Arthroscopic irrigation/insufflation system

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic access cannula, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic access cannula, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Electromechanical device/system transport trolley

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Device sterilization/disinfection container, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone tap, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone awl, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Partial shoulder prosthesis

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone staple, non-adjustable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Internal orthopaedic fixation system, cerclage wire/cable, sterile

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical screwdriver, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical instrument handle, non-torque-limiting

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical implant/trial-implant/sizer holder, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical implant/trial-implant/sizer holder, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical implant template, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical drill guide, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical drill guide, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Scalpel handle, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implantation sleeve, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implantable-device cutter

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implant-instrument extension adaptor, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic graft inserter

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic fixation implant alignment tool

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic cerclage applier

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Limb/torso/head restraint, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Leg procedure positioner

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Knee femur prosthesis trial, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Hand-held surgical retractor, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Fluted surgical drill bit, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Endoscopic surgical probe

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Electrical mains power cable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Endoscopic-access dilator, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone-resection orthopaedic reamer, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone tunnel plug, non-cannulated

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone hook

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone file/rasp, manual, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone curette, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arm procedure positioner, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Drilling power tool attachment, basic

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Cannulated surgical drill guiding pin

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Cannulated surgical drill bit, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Cannulated surgical drill bit, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone-resection orthopaedic reamer, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone-coring punch, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone tap, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone tap, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone marrow biopsy procedure kit

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone lever/elevator, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone graft funnel

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone file/rasp, manual, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone approximation clamp

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone access cannula

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Shoulder glenoid fossa prosthesis, prefabricated

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic obturator

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone approximation clamp

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone lever/elevator, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone trephine

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Chisel/osteotome blade handle

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Dressing/utility forceps, tweezers-like, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Endoscope sheath, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Endoscopic surgical probe

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

General-purpose surgical spatula

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Joint prosthesis implantation kit, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Knee tibia prosthesis trial, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Manual orthopaedic bender, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone screw starter/notcher

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implant aiming/guiding block, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implant impactor, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic operating table top

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic osteotome

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic reamer guide

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic surgical distractor, internal

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Osteotomy guide, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Rigid endoscopic tissue manipulation forceps, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical countersink, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical depth gauge, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical flat-nosed pliers

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical implant handling forceps

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical instrument handle, torque-limiting

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Tendon/ligament graft preparation station post

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Tendon/ligament graft preparation station base

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Tendon/ligament graft preparation station

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Tendon stripper

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Suturing unit, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Suture knot pusher, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Suture cutter, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical tamp, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical instrument torque limiter

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical instrument guard, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical implant template, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Soft-tissue surgical hook, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Rigid endoscope obturator

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Rigid arthroscope, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic trocar blade, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic osteotome blade, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implant/instrument assembling device

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implant driver

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic graft tensioner, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic casting stand

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Knee arthroplasty force sensor balance kit

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Instrument tray, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

General-purpose surgical scissors, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Fluted surgical drill bit, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Endoscope video camera

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Dressing/utility forceps, scissors-like, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Uncoated shoulder humeral stem prosthesis

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Total shoulder prosthesis

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Foot-switch, electrical

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Suturing unit, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Tendon/ligament bone anchor, non-bioabsorbable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Tendon/ligament bone anchor, bioabsorbable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Coated shoulder humeral stem prosthesis

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone pin, bioabsorbable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone screw, bioabsorbable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Total reverse shoulder prosthesis

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Suturing unit, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical staple loading unit, non-cutting

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical staple loading unit, non-cutting

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical instrument/implant depth limiter

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Polyolefin/fluoropolymer suture, multifilament

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone washer, sterile

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone washer, non-sterile

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Endoscopic electrosurgical electrode, bipolar, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic surgical procedure kit, non-medicated, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Suturing unit, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Suture knot pusher, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical tamp, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical screwdriver, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical saw blade, sagittal, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical saw blade, reciprocating, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical saw blade, reciprocating, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical saw blade, oscillating, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical instrument handle grip

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical finger guard

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical drill guide, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical drill guide, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical depth gauge, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Scalpel handle, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Rigid optical laparoscope

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Patella prosthesis trial

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic trocar blade, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic surgical procedure kit, non-medicated, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic osteotome

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic osteotome

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic knee/leg holder liner

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implant aiming/guiding block, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic graft guide

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic casting stand

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bur, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone screw starter/notcher

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone screw starter/notcher

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Knee femur prosthesis trial, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Frame/rail/pole device holder

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Fluted surgical drill bit, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Fluted surgical drill bit, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Fluted surgical drill bit, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Fluted surgical drill bit, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Endoscope video camera

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Endoscope sheath, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Electrical-only medical device connection cable, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Drilling power tool attachment, basic

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Decontamination floor mat, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Centrifuge bucket/tube holder

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Cannulated surgical drill bit, single-use, non-sterile

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Cannulated surgical drill bit, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Cannulated surgical drill bit, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone-resection orthopaedic reamer, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone-resection orthopaedic reamer, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone-resection orthopaedic reamer, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone tunnel plug, non-cannulated

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical instrument/implant rack

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Wire cutter

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone trephine

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone trephine

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone marrow biopsy needle, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone lever/elevator, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Body aspiration needle, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic surgical procedure kit, non-medicated, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Tendon/ligament graft preparation station post

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Tendon/ligament graft preparation station base

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Tendon stripper

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Suture knot pusher, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical torque wrench, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical saw blade, sagittal, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical irrigation tubing set, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical instrument handle, non-torque-limiting

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical implant/trial-implant/sizer holder, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical implant template, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical drill guide, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical drill chuck key

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical depth gauge, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical depth gauge, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Shoulder reverse/standard adaptor prosthesis trial

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Shoulder glenoid fossa prosthesis trial

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Sawing power tool attachment, reciprocating

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Rigid endoscope obturator

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Rigid arthroscope, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Reverse shoulder head prosthesis trial

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic surgery tissue debris collector, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic reamer guide

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic prosthesis implantation positioning instrument, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic osteotome blade, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic osteotome blade, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic osteotome blade, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic osteotome

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implantation sleeve, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implantable-device cutter

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implant inserter/extractor, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implant impactor, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implant driver

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic broach

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone wire

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Medullary canal orthopaedic reamer, flexible

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Medullary canal orthopaedic reamer, flexible

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Medical equipment drape, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Knee tibia prosthesis trial, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Joint prosthesis implantation kit, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Humeral head prosthesis trial, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Haematological concentrate system preparation kit, thrombin separation

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Fluted surgical drill bit, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Fluted surgical drill bit, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic surgical procedure kit, non-medicated, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic surgical procedure kit, non-medicated, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic shaver system, electrically-powered

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic irrigation/insufflation system

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Adhesive bandage

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arm procedure positioner, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic access cannula seal, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic irrigation/insufflation system

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic shaver system handpiece, electrically-powered

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic surgical procedure kit, non-medicated, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone hook

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone tap, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone-resection orthopaedic reamer, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone-resection orthopaedic reamer, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Bone/joint surgical power tool motorized handpiece/set, electric, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Cannulated surgical drill bit, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Crown surgical drill bit, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Decontamination floor mat, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Endoscopic-access dilator, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Endoscopic-access dilator, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Endoscopic-access dilator, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Fluted surgical drill bit, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Fluted surgical drill bit, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Foot-switch, electrical

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

General internal orthopaedic fixation system implantation kit

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Glenoid defect sizer

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Haematological concentrate system preparation kit, platelet concentration

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Hand-held surgical retractor, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Humeral body prosthesis trial

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Humeral head spacer prosthesis trial

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Humeral stem prosthesis trial, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Laparoscopic trocar blade, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Low-pressure tubing connector, single-use, sterile

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Manual scalpel blade, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Medical ruler, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Medullary canal orthopaedic reamer, flexible

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone wire

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bone wire

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic bur, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic graft guide

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic graft guide

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic graft inserter

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic graft tensioner, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implant impactor, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic implant-instrument extension adaptor, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic surgical distractor, internal

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic surgical distractor, internal

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Orthopaedic surgical procedure kit, non-medicated, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Osteotomy guide, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Portable/mobile rechargeable battery pack

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Reverse bone-resection orthopaedic reamer

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Reverse shoulder cup prosthesis trial, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Sawing power tool attachment, reciprocating

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Soft-tissue surgical hook, reusable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical camera holder

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical implant template, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical irrigation tubing set, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Surgical tissue/fluid collection bag, non-sterile

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Suturing needle, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Suturing unit, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Suturing unit, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Suturing unit, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Tendon stripper

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Tendon/ligament bone anchor, non-bioabsorbable

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Tendon/ligament graft preparation station

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Wire/ligature passer, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Wire/ligature passer, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

X-ray film magnifying glass

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic access cannula seal, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Blood centrifugation system containment kit

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Battery box

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic surgical procedure kit, non-medicated, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic shaver system, electrically-powered

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic shaver system blade, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic obturator

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Arthroscopic access cannula, single-use

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Apheresis system

Manufacturer:

Arthrex Inc

Type:

General Medical Device

Registration Date:

Sep 22, 2021

Root canal post, preformed

Manufacturer:

Edenta Etablissement

Type:

General Medical Device

Registration Date:

Sep 21, 2021

Dental restoration retention pin

Manufacturer:

Edenta Etablissement

Type:

General Medical Device

Registration Date:

Sep 21, 2021

Podiatric bur, reusable

Manufacturer:

Edenta Etablissement

Type:

General Medical Device

Registration Date:

Sep 21, 2021

Diamond dental bur, reusable

Manufacturer:

Edenta Etablissement

Type:

General Medical Device

Registration Date:

Sep 21, 2021

Steel dental bur, reusable

Manufacturer:

Edenta Etablissement

Type:

General Medical Device

Registration Date:

Sep 21, 2021

Manual endodontic file/rasp, reusable

Manufacturer:

Edenta Etablissement

Type:

General Medical Device

Registration Date:

Sep 21, 2021

Carbide dental bur, reusable

Manufacturer:

Edenta Etablissement

Type:

General Medical Device

Registration Date:

Sep 21, 2021

Dental abrasive point, reusable

Manufacturer:

Edenta Etablissement

Type:

General Medical Device

Registration Date:

Sep 21, 2021

Radiology PACS software

Manufacturer:

Gleamer

Type:

General Medical Device

Registration Date:

Sep 20, 2021

Ostomy convexity insert

Manufacturer:

Fistula Solution Corporation

Type:

General Medical Device

Registration Date:

Sep 15, 2021

Dental impression tray material

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Sep 8, 2021

Dental appliance fabrication material, resin

Manufacturer:

Dreve Dentamid GmbH

Type:

General Medical Device

Registration Date:

Sep 8, 2021

Indwelling urethral drainage balloon catheter, non-antimicrobial

Manufacturer:

Measurement Specialties Inc.

Type:

General Medical Device

Registration Date:

Sep 3, 2021

General-purpose patient temperature probe, reusable

Manufacturer:

Measurement Specialties Inc.

Type:

General Medical Device

Registration Date:

Sep 3, 2021

General-purpose patient temperature probe, single-use

Manufacturer:

Measurement Specialties Inc.

Type:

General Medical Device

Registration Date:

Sep 3, 2021

Pneumatic dental handpiece coupler

Manufacturer:

DentalEZ, Inc, StarDental Division

Type:

General Medical Device

Registration Date:

Sep 2, 2021

Dental power tool system, pneumatic

Manufacturer:

DentalEZ, Inc, StarDental Division

Type:

General Medical Device

Registration Date:

Sep 2, 2021

Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable

Manufacturer:

DentalEZ, Inc, StarDental Division

Type:

General Medical Device

Registration Date:

Sep 2, 2021

Pneumatic dental scaling/debridement system

Manufacturer:

DentalEZ, Inc, StarDental Division

Type:

General Medical Device

Registration Date:

Sep 2, 2021

Pneumatic dental power tool hose

Manufacturer:

DentalEZ, Inc, StarDental Division

Type:

General Medical Device

Registration Date:

Sep 2, 2021

Diamond dental bur, reusable

Manufacturer:

DentalEZ, Inc, StarDental Division

Type:

General Medical Device

Registration Date:

Sep 2, 2021

Dental power tool system handpiece, pneumatic

Manufacturer:

DentalEZ, Inc, StarDental Division

Type:

General Medical Device

Registration Date:

Sep 2, 2021

Ceramic dental bur

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Pneumatic dental power tool system handpiece tip, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Ceramic dental bur

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Carbide dental bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Radiation therapy software

Manufacturer:

LifeLine Software, Inc.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Diamond dental bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Fixture/appliance dental drill bit, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Fixture/appliance dental drill bit, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Dental abrasive disk, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Steel dental bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Pneumatic dental power tool system handpiece tip, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Diamond dental bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Arthroplasty force sensor display unit

Manufacturer:

OrthoSensor, Inc.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Arthroplasty force sensor

Manufacturer:

OrthoSensor, Inc.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Intraoperative orthopaedic bone pin/screw, single-use

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Podiatric bur, reusable

Manufacturer:

Gebr. Brasseler GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Monitoring spirometer, electrical

Manufacturer:

Respiratory Motion, Inc

Type:

General Medical Device

Registration Date:

Aug 24, 2021

Monitoring spirometer, electrical

Manufacturer:

Respiratory Motion, Inc

Type:

System or Procedure Pack

Registration Date:

Aug 24, 2021

Monitoring spirometer, electrical

Manufacturer:

Respiratory Motion, Inc

Type:

General Medical Device

Registration Date:

Aug 24, 2021

Surgical retractor/retraction system blade, reusable

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

May 24, 2021

Skull clamp

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

May 24, 2021

Multi-purpose therapeutic saline solution

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

May 24, 2021

Aneurysm clip applier

Manufacturer:

MIZUHO Corporation

Type:

General Medical Device

Registration Date:

May 24, 2021

Orthopaedic bur, reusable

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Orthopaedic instrument extractor

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Orthopaedic trocar blade, reusable

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Surgical implant handling forceps

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Surgical torque wrench, reusable

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Surgical instrument handle, non-torque-limiting

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Orthopaedic x-ray reference grid

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Surgical depth gauge, reusable

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Distraction plate/rod adjustment remote control

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Long bone distraction rod receiver

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Medullary canal orthopaedic reamer, rigid

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Orthopaedic implantation hammering attachment

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Orthopaedic implant driver

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Surgical implant/trial-implant/sizer holder, reusable

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Bone nail trial

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

General internal orthopaedic fixation system implantation kit

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Long bone distraction rod, motorized

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Orthopaedic bone wire

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Surgical drill guide, reusable

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Orthopaedic implantation sleeve, reusable

Manufacturer:

WITTENSTEIN intens GmbH

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 16, 2021

Cardiac/peripheral vascular guidewire, single-use

Manufacturer:

Brivant Limited T/A Lake Region Medical

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 5, 2021

Temporary cardiac pacing catheter

Manufacturer:

Brivant Limited T/A Lake Region Medical

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

May 5, 2021

Cardiac/peripheral vascular guidewire, single-use

Manufacturer:

Brivant Limited T/A Lake Region Medical

Type:

General Medical Device

Registration Date:

May 5, 2021

Peripheral vascular guidewire, manual

Manufacturer:

Brivant Limited T/A Lake Region Medical

Type:

General Medical Device

Registration Date:

May 5, 2021

Manual intraocular lens injector, single-use

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

May 3, 2021

Epicardial pacing lead inserter

Manufacturer:

Greatbatch Ltd. d/b/a Greatbatch Medical

Type:

Active Implantable Device

Registration Date:

May 3, 2021

Pacing/defibrillation lead electrical adaptor

Manufacturer:

Greatbatch Ltd. d/b/a Greatbatch Medical

Type:

Active Implantable Device

Registration Date:

May 3, 2021

Posterior-chamber intraocular lens, pseudophakic

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

May 3, 2021

Anterior-chamber intraocular lens, pseudophakic

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

May 3, 2021

Anterior-chamber intraocular lens, phakic

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

May 3, 2021

Capsular tension ring

Manufacturer:

Ophtec BV

Type:

General Medical Device

Registration Date:

May 3, 2021

Surgical implant/trial-implant/sizer holder, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

May 1, 2021

Long bone distraction rod, motorized

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

May 1, 2021

Surgical implant handling forceps

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

May 1, 2021

Long bone distraction rod, motorized

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

May 1, 2021

Orthopaedic implant driver

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

May 1, 2021

Bone nail trial

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

May 1, 2021

Orthopaedic x-ray reference grid

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

May 1, 2021

Orthopaedic instrument extractor

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

May 1, 2021

Orthopaedic trocar blade, reusable

Manufacturer:

Orthofix S.r.l.

Type:

General Medical Device

Registration Date:

May 1, 2021

Endodontic filling/sealing material

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Apr 30, 2021

Root canal post kit

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Apr 30, 2021

Temporary dental crown/bridge

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Apr 30, 2021

Sacral plexus implantable incontinence-control electrical stimulation system

Manufacturer:

Axonics Modulation Technologies

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Apr 30, 2021

Vascular catheter introduction set, nonimplantable

Manufacturer:

Creganna Medical

Type:

General Medical Device

Registration Date:

Apr 30, 2021

Rotary/reciprocating endodontic file/rasp, reusable

Manufacturer:

META BIOMED CO., LTD.

Type:

General Medical Device

Registration Date:

Apr 30, 2021

Neurovascular embolization plug

Manufacturer:

Balt Extrusion SAS

Type:

General Medical Device

Registration Date:

Apr 29, 2021

Baroreceptor electrical stimulation system

Manufacturer:

CVRx, Inc.

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Apr 29, 2021

Descending thoracic aorta endovascular stent-graft

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Apr 28, 2021

Non-neurovascular embolization plug, metallic

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Apr 28, 2021

Abdominal aorta endovascular stent-graft

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Apr 28, 2021

Peripheral angioplasty balloon catheter, basic

Manufacturer:

Lifetech Scientific (Shenzhen) Co Ltd

Type:

General Medical Device

Registration Date:

Apr 28, 2021

Arthroscopic surgical procedure kit, non-medicated, reusable

Manufacturer:

Active Implants Israel Ltd.

Type:

General Medical Device

Registration Date:

Apr 21, 2021

Meniscus prosthesis

Manufacturer:

Active Implants Israel Ltd.

Type:

General Medical Device

Registration Date:

Apr 21, 2021

Orthopaedic surgical procedure kit, non-medicated, single-use

Manufacturer:

Active Implants Israel Ltd.

Type:

General Medical Device

Registration Date:

Apr 21, 2021

Data sourced from the Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom.

Last updated: December 2025