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Advena Ltd

Authorized Representative in the United Kingdom

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Warwick, England, United Kingdom

Postcode: CV34 6WE

Relationship Type: UK Responsible Person
1770 Products Represented
295 Manufacturers
Total Products
1770
Manufacturers
295
Device Types
4
Generic Names
1077
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (1770)
Complete portfolio registered with MHRA

Multiple drugs of abuse IVD, control

Manufacturer:

Biochemical Diagnostics, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Device sterilization/disinfection container, reusable

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Disposable vacuum tubing

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous pole

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft-tissue ultrasonic surgical system handpiece tip, single-use

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound therapy ultrasound system handpiece

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound therapy ultrasound system handpiece tip

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair back rest positioner

Manufacturer:

Motion Concepts

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair back rest positioner pin

Manufacturer:

Motion Concepts

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair headrest

Manufacturer:

Motion Concepts

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression material mixer

Manufacturer:

Motion Dental Equipment Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

MOVMEDIX

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ligament reconstruction instrument set, reusable

Manufacturer:

MOVMEDIX

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic graft tensioner, reusable

Manufacturer:

MOVMEDIX

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilization packaging, single-use

Manufacturer:

E.LINE S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arthroscopic shaver system, electrically-powered

Manufacturer:

Eberle GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone trephine set

Manufacturer:

Eberle GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone trephine tubing set

Manufacturer:

Eberle GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient general health self-management software

Manufacturer:

Infermedica Sp. z o.o.,

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Innolatex (Thailand) Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medicine spoon, reusable

Manufacturer:

elm-plastic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ear dropper, reusable

Manufacturer:

EmergoPharm Spółka z ograniczona odpowiedzialnością Sp. K.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal mucosa dressing, non-antimicrobial

Manufacturer:

EmergoPharm Spółka z ograniczona odpowiedzialnością Sp. K.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acetabular orthopaedic reamer

Manufacturer:

Enztec Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic graft tensioner, reusable

Manufacturer:

Enztec Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

Enztec Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Enztec Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tendon/ligament graft preparation station post

Manufacturer:

Enztec Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic roller pump

Manufacturer:

Meditrina Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hysteroscopic irrigation/insufflation system

Manufacturer:

Meditrina Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue morcellation system handpiece, line-powered

Manufacturer:

Meditrina Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

X-ray image interpretive software

Manufacturer:

Qure.ai Technologies Private Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermal curette

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Exhaled-gas oesophageal intubation detector, adult

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

In-line CPAP set, non-nebulizing

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

PEEP valve, single-use

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulmonary resuscitator, manual, reusable

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ventilator breathing circuit, single-use

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lifting seat cushion

Manufacturer:

Life Assistant Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiation therapy software

Manufacturer:

Limbus AI Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatoscope, optical

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixed examination/treatment room light

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical stethoscope

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Otoscope, direct

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percussion hammer, manual, reusable

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Mah Sing Healthcare Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual scalpel blade, single-use

Manufacturer:

Aditya Dispomed Products Private Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

AIRS Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental power tool system handpiece, remotely-driven

Manufacturer:

Aseptico Inc.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Endodontic obturation system

Manufacturer:

Aseptico Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient monitoring system module, multifunction

Manufacturer:

AtCor Medical Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Manufacturer:

B&H Surgical Instrument

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

B&H Surgical Instrument

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal oesophageal stent

Manufacturer:

bess pro gmbh

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Silicone-sheet tissue reconstructive material

Manufacturer:

bess pro gmbh

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Silicone-sheet tissue reconstructive material

Manufacturer:

bess pro gmbh

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient surgical drape, single-use

Manufacturer:

BETATEX S.p.a

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Image segmentation application software

Manufacturer:

Cedars-Sinai Medical Center

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental x-ray image interpretive software

Manufacturer:

Corilus NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manometric gastrointestinal motility analysis system

Manufacturer:

Diversatek Healthcare, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automated ophthalmic refractometer

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bench-top keratometer

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye anterior segment analyser

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument table

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic fundus camera

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic solid-state laser system

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Retinal optical coherence tomography system

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scanning-laser ophthalmic imaging system

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vision testing/training chart

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic electric hospital bed

Manufacturer:

NİTROCARE MEDİKAL MOBİLYA SANAYİ VE TİCARET ANONİM ŞİRKETİ

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hospital stretcher, manual

Manufacturer:

NİTROCARE MEDİKAL MOBİLYA SANAYİ VE TİCARET ANONİM ŞİRKETİ

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Kinesiology/electromyographic sensor set

Manufacturer:

Noraxon USA, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Manufacturer:

PSI/EYE-KO, Inc. dba Anodyne Surgical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic needle, single-use

Manufacturer:

PSI/EYE-KO, Inc. dba Anodyne Surgical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound drainage kit

Manufacturer:

Redax S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pleural catheter

Manufacturer:

Redax S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction/irrigation tubing, single-use

Manufacturer:

Redax S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical capillary wound drain, non-luminal

Manufacturer:

Redax S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Whole-blood-recovery autotransfusion system, manual

Manufacturer:

Redax S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Accelerator system synchronizer

Manufacturer:

Anzai Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Synovial fluid supplementation medium

Manufacturer:

Bohus BioTech AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Exudate-absorbent dressing, non-gel, non-antimicrobial

Manufacturer:

Cerdak (Pty) Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

HYCOR Biomedical Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Centrifuge tube IVD

Manufacturer:

LP ITALIANA SPA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori urease IVD, reagent

Manufacturer:

Strong Biotech Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw (non-sliding)

Manufacturer:

Australian Orthopaedic Fixations Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sleep apnoea pillow

Manufacturer:

Choice One Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Airway device cleaning utensil, noninvasive, reusable

Manufacturer:

Choice One Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device cleaning agent

Manufacturer:

Choice One Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dynamic visual acuity testing system

Manufacturer:

Inventis S.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Otoscope, direct

Manufacturer:

Inventis S.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermal curette

Manufacturer:

Jai Surgicals Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel, single-use

Manufacturer:

Jai Surgicals Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin biopsy blade

Manufacturer:

Jai Surgicals Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic electric home bed

Manufacturer:

Xiamen Atlantis Mfc Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bedrail

Manufacturer:

Xiamen Atlantis Mfc Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body-surface pressure mapping system

Manufacturer:

XSENSOR Technology Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ZENMED Tıbbi Cihazlar Ve Sağlık Ürünleri San. Ve Tic. Ltd. Şti.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile patient lifting system, electrically-powered

Manufacturer:

Apex Health Care Mfg.,Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device sterilization/disinfection container, reusable

Manufacturer:

PSM Pacific Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

PSM Pacific Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

PSM Pacific Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous pole, ceiling-mounted

Manufacturer:

provita medical gmbh & co. Kg

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous track/carrier system

Manufacturer:

provita medical gmbh & co. Kg

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair, attendant-driven, non-collapsible

Manufacturer:

provita medical gmbh & co. Kg

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flotation therapy bed, adult

Manufacturer:

Phoenix Innovative Healthcare Manufacturers Pvt Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-cleaning wipe, non-sterile

Manufacturer:

Phoenix Innovative Healthcare Manufacturers Pvt Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resin artificial teeth

Manufacturer:

Polident D.O.O.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge

Manufacturer:

Polident D.O.O.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Noninvasive device battery charger

Manufacturer:

PRODOL MEDITEC LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video intubation laryngoscope imaging system

Manufacturer:

PRODOL MEDITEC LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tooth dryer

Manufacturer:

Pulpdent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material mixing surface, chairside, single-use

Manufacturer:

Pulpdent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental root surface conditioner

Manufacturer:

Pulpdent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam, non-latex

Manufacturer:

Pulpdent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General specimen microscopy slide IVD, single-use

Manufacturer:

Trajan Scientific Australia Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General tissue specimen container IVD, fixative/saline

Manufacturer:

Trajan Scientific Australia Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Histological tissue cassette biopsy insert IVD

Manufacturer:

Trajan Scientific Australia Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Paraffin-based embedding medium IVD

Manufacturer:

Trajan Scientific Australia Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Scalpel handle, reusable

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation/aspiration cannula, illuminating, single-use

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/examination garment kit

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrode conductive skin pad, single-use

Manufacturer:

Hurev Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External defibrillation electrode, adult, single-use

Manufacturer:

Hurev Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External defibrillation electrode, paediatric, single-use

Manufacturer:

Hurev Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Manufacturer:

Hurricane Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Syndesmotome

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone curette, reusable

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental elevator, sinus lift

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental suction system cannula, single-use

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hot/cold therapy pack, single-use

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual non-rotary dental instrument handle

Manufacturer:

HYGITECH

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Periosteal elevator, reusable

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical dressing/drape kit, single-use

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic insole, prefabricated, non-antimicrobial

Manufacturer:

ICB Medical Distributors PTY LTD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endotracheal tube cuff inflator

Manufacturer:

IDMED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pupillograph

Manufacturer:

IDMED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

Imaging Biometrics, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical cap, single-use

Manufacturer:

ALLE S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic intravenous administration set, noninvasive

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Citric acid haemodialysis system cleaning cartridge

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis needle

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis system dialysate pyrogen filter

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hollow-fibre haemodialysis dialyser, single-use

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, control

Manufacturer:

EIKEN CHEMICAL Co., Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, calibrator

Manufacturer:

EIKEN CHEMICAL Co., Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood immunoassay analyser IVD

Manufacturer:

EIKEN CHEMICAL Co., Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, agglutination

Manufacturer:

EIKEN CHEMICAL Co., Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical

Manufacturer:

IQ Products B.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Intraoral optical scanning system

Manufacturer:

3D Imaging & Simulation Corp Americas

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bladder evacuator, single-use

Manufacturer:

ACE Medical Devices Pvt Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, kit, rapid ICT, clinical

Manufacturer:

Bloom Diagnostics AG

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone (TSH) IVD, kit, rapid ICT, clinical

Manufacturer:

Bloom Diagnostics AG

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Surgical instrument/endoscope cleaning utensil, single-use

Manufacturer:

PriMed Instruments Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Calf/shin orthosis

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cervical spine collar, reusable

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot orthosis

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracolumbosacral spine orthosis, flexible

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Toe separator

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tubular support bandage, non-latex, reusable

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wrist orthosis

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound drain, non-bioabsorbable

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluid transfer set, general-purpose

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heat/moisture exchanger, single-use

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostoma button

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube cannula, single-use

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube speech valve

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube, non-reinforced, non-customized, reusable

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device cleaning/disinfection wipe

Manufacturer:

Kleen-Pak Products Pte Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic male condom, Hevea-latex

Manufacturer:

Karex Industries Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body-orifice ultrasound imaging transducer cover, basic

Manufacturer:

Karex Industries Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oral/vaginal sex barrier, Hevea-latex

Manufacturer:

Karex Industries Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical procedure irrigation fluid

Manufacturer:

Legency Remedies Private Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic manual linear cutting stapler, single-use

Manufacturer:

Lexington Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical staple loading unit, cutting

Manufacturer:

Lexington Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Retinal image analysis software

Manufacturer:

MediWhale Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bioelectrical body composition analyser

Manufacturer:

Mediana Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anaesthesia face mask, single-use

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breathing circuit catheter mount, single-use

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gas-sampling/monitoring respiratory tubing, single-use

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heat/moisture exchanger, single-use

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heat/moisture exchanger, single-use

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heat/moisture exchanger/microbial filter, sterile

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ventilator breathing circuit, single-use

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Y-piece breathing circuit connector, single-use

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steam sterilizer

Manufacturer:

MELAG Medizintechnik GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Natural gutta-percha

Manufacturer:

META SYSTEMS CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic laser system beam guide

Manufacturer:

Peregrine Surgical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wearable multiple physiological parameter recorder, reusable

Manufacturer:

BioSensics, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Head-worn lamp

Manufacturer:

Bistos Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Overhead infant phototherapy unit

Manufacturer:

Bistos Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip/knee/ankle/foot orthosis

Manufacturer:

Solushin Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood pressure cuff, reusable

Manufacturer:

Solaris Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood pressure cuff, single-use

Manufacturer:

Solaris Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulse oximeter probe, reusable

Manufacturer:

Solaris Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Assistive pushchair

Manufacturer:

Spex Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair back rest positioner

Manufacturer:

Spex Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair legrest pad

Manufacturer:

Spex Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical tip cleaning pad

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic bite block, basic, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray corner protector, reusable

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device cleaning sponge/set

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device disinfection agent

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device disinfection agent

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device disinfection agent

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin marking pen, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilization container mat

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument guard, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument guard, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument interim-placement holder, reusable

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument interim-placement holder, reusable

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular booties

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose percutaneous abdominothoracic drainage catheter

Manufacturer:

Bearpac Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pleural/peritoneal drainage catheterization kit

Manufacturer:

Bearpac Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pleural/peritoneal drainage catheterization kit

Manufacturer:

Bearpac Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-cover adhesive strip, non-antimicrobial

Manufacturer:

Strapit Medical & Sports Supplies Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Custom-made spine orthosis

Manufacturer:

Surestep LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic insole, prefabricated, antimicrobial

Manufacturer:

Foot Science International Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic insole, prefabricated, non-antimicrobial

Manufacturer:

Foot Science International Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiopulmonary resuscitation mask, single-use

Manufacturer:

Foremount Enterprise., Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endotracheal tube introducer, single-use

Manufacturer:

Foremount Enterprise., Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ventilator breathing circuit, single-use

Manufacturer:

Foremount Enterprise., Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

Formlabs Ohio Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Circulating-air whole-body heating system control unit

Manufacturer:

Gentherm Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Circulating-air whole-body heating system control unit

Manufacturer:

Gentherm Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Gentherm Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screwing power tool attachment

Manufacturer:

KJ Meditech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye irrigation solution, synthetic

Manufacturer:

Schalcon S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye lubricant

Manufacturer:

Schalcon S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Credo Diagnostics Biomedical Pte. Ltd. Taiwan branch

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Credo Diagnostics Biomedical Pte. Ltd. Taiwan branch

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Credo Diagnostics Biomedical Pte. Ltd. Taiwan branch

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bandage scissors, reusable

Manufacturer:

TyTek Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Emergency airway clearance suction system, manual

Manufacturer:

TyTek Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow orthosis

Manufacturer:

United Pacific Industries Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lumbar spine orthosis

Manufacturer:

United Pacific Industries Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

Van Straten Medical B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube guide-catheter

Manufacturer:

Venner Medical (Singapore) Pte Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incontinence penis clamp, reusable

Manufacturer:

BioDerm, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electroencephalographic electrode cap, single-use

Manufacturer:

WAVi Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bed/chair electric massager

Manufacturer:

Wellness Nordic A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urine flowmeter, single-use

Manufacturer:

SINAPI Biomedical (Pty) Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SW Sustainability Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Exudate-absorbent dressing, non-gel, non-antimicrobial

Manufacturer:

T&L Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laser patient positioning system

Manufacturer:

Neorad B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot-switch, electrical

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurosurgical retraction obturator mounting rod

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open surgical site internal light

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical suction system collection container, single-use

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue morcellation system control unit

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue morcellation system handpiece, line-powered

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue morcellation system handpiece, line-powered

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microbial susceptibility testing interpretive software IVD

Manufacturer:

INTELLIGENCE ARTIFICIELLE APPLICATIONS – I2A

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antimicrobial susceptibility analyser IVD

Manufacturer:

Quantamatrix Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antibacterial susceptibility testing kit IVD

Manufacturer:

Quantamatrix Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General utility supply system, ceiling-mounted

Manufacturer:

Ondal Medical Systems GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General utility supply system, ceiling-mounted

Manufacturer:

Ondal Medical Systems GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical monitor/light mount

Manufacturer:

Ondal Medical Systems GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical procedure irrigation fluid

Manufacturer:

OriGen Biomedical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Assistive ergonomic chair/table base

Manufacturer:

Orthosanit Diffusion S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Assistive pushchair

Manufacturer:

Orthosanit Diffusion S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair back rest positioner

Manufacturer:

Orthosanit Diffusion S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medicine cup, single-use

Manufacturer:

Hammarplast Medical AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tourniquet cuff, reusable

Manufacturer:

Hammarplast Medical AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bariatric bed

Manufacturer:

HEALTHNITURE S.r.l. a socio unico

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Otoscope, direct

Manufacturer:

hearX SA (Pty) Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tone audiometer

Manufacturer:

hearX SA (Pty) Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymeric oesophageal stent, non-bioabsorbable

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Trachea prosthesis

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube decannulation cap

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiac/peripheral vascular guidewire, single-use

Manufacturer:

BrosMed Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral angioplasty balloon catheter, basic

Manufacturer:

BrosMed Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter introduction set, nonimplantable

Manufacturer:

BrosMed Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular microcatheter

Manufacturer:

BrosMed Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

Camp Scandinavia AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

Camp Scandinavia AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthosis suspension unit

Manufacturer:

Camp Scandinavia AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-respiratory device ambient air filter

Manufacturer:

Tarry Medical Products Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement, non-antimicrobial

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer orthopaedic cement restrictor, bioabsorbable

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vertebral bone filler, non-bioabsorbable

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vertebral bone filler, non-bioabsorbable

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone access cannula

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone access cannula

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cranial resinous compound

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cranial resinous compound

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cranioplasty plate, non-alterable

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Femoral canal sponge

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intramedullary canal cleaning brush, single-use

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement compressor

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement injection cannula

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement mixing bowl

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement mixing bowl

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement spacer

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement spacer

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement spacer

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement spacer

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement-chilling device

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement, antimicrobial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement, antimicrobial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant template, reusable

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment drape, single-use

Manufacturer:

TİO MEDİKAL TIBBİ ÜRÜNLER TURİZM İNŞAAT SAN.VE TİC.LTD.ŞTİ.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cervical cytology brush

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ear canal irrigation kit, single-use

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ear canal irrigation syringe

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foetal stethoscope

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held examination/treatment light

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Battery box

Manufacturer:

Total Healthcare Innovation GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Portable/mobile rechargeable battery pack

Manufacturer:

Total Healthcare Innovation GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical gown, single-use

Manufacturer:

Total Healthcare Innovation GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Interproximal reduction kit

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic archwire

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic archwire/bracket ligature

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket, metal

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic lock

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic retainer

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic wire

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intrauterine device thread extractor

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngoscope handle, single-use

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal speculum, single-use

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid sigmoidoscope

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid optical bronchoscope

Manufacturer:

NOVATECH SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posterior-chamber intraocular lens, pseudophakic

Manufacturer:

Hanita Lenses

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Allergy testing lancet

Manufacturer:

J. N. Eberle Federnfabrik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye lubricant

Manufacturer:

IROMED GROUP S.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bed scale

Manufacturer:

Howard Wright Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glucose IVD, reagent

Manufacturer:

Hygieia, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

ENFit oral/enteral syringe, single-use

Manufacturer:

PENTAFERTE ITALIA s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose syringe, single-use

Manufacturer:

PENTAFERTE ITALIA s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose syringe/needle

Manufacturer:

PENTAFERTE ITALIA s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasogastric feeding tube

Manufacturer:

PENTAFERTE ITALIA s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oral/enteral syringe drawing-up straw

Manufacturer:

PENTAFERTE ITALIA s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stopcock

Manufacturer:

PENTAFERTE ITALIA s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ethyl glucuronide (EtG) IVD, control

Manufacturer:

Biochemical Diagnostics, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human chorionic gonadotropin beta-core fragment IVD, control

Manufacturer:

Biochemical Diagnostics, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Basic electric hospital bed

Manufacturer:

Howard Wright Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medicine cup, single-use

Manufacturer:

Hammarplast Medical AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tourniquet cuff, single-use

Manufacturer:

Hammarplast Medical AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument linear advancement system

Manufacturer:

CASCINATION AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Attendant-only-propelled wheelchair, non-bariatric

Manufacturer:

PDG Product Design Group Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Push-rim manual wheelchair, non-bariatric

Manufacturer:

PDG Product Design Group Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Examination/treatment table paper holder

Manufacturer:

Pearl Technology AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Headphone cover

Manufacturer:

Pearl Technology AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment/instrument drape, reusable

Manufacturer:

Pearl Technology AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENFit oral/enteral syringe, single-use

Manufacturer:

PENTAFERTE ITALIA s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Enteral feeding noninvasive-component set

Manufacturer:

PENTAFERTE ITALIA s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Enteral tube extension

Manufacturer:

PENTAFERTE ITALIA s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vial/bottle adaptor, non-hermetic

Manufacturer:

PENTAFERTE ITALIA s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Coronary angioplasty balloon catheter, basic

Manufacturer:

BrosMed Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Coronary angioplasty balloon catheter, cutting/scoring

Manufacturer:

BrosMed Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Compression/pressure sock/stocking, reusable

Manufacturer:

Calze G.T. S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Compression/pressure shirt/pants

Manufacturer:

Camp Scandinavia AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lumbar spine orthosis

Manufacturer:

Camp Scandinavia AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Circulating-air whole-body heating system control unit

Manufacturer:

Care Essentials Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Care Essentials Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

HYCOR Biomedical Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

LP ITALIANA SPA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

LP ITALIANA SPA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD

Manufacturer:

LP ITALIANA SPA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Test tube/reservoir cap IVD

Manufacturer:

LP ITALIANA SPA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoelectric gastrointestinal motility analysis system

Manufacturer:

Alimetry Ltd.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Myoelectric gastrointestinal motility analysis system

Manufacturer:

Alimetry Ltd.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Assisted reproduction microtool

Manufacturer:

ICSION Medical Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dried blood spot collection kit IVD

Manufacturer:

Trajan Scientific Australia Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dried blood spot collection receptacle IVD

Manufacturer:

Trajan Scientific Australia Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microtome blade IVD, reusable

Manufacturer:

Trajan Scientific Australia Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hypodermic needle, single-use

Manufacturer:

Hurricane Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Syringe filter, clinical

Manufacturer:

Hurricane Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone cutting forceps, reusable

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone holding forceps

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental anaesthesia syringe, reusable

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental mirror, reusable

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental osteotome

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental surgical scissors

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial reciprocating scalpel blade

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device-irrigation sterile saline solution

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing/utility forceps, tweezers-like, reusable

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hot/cold therapy pack, reusable

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Periodontal probe, reusable

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation/aspiration cannula, illuminating, single-use

Manufacturer:

HYGITECH

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Suturing needle holder, reusable

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thrombectomy rotational catheter

Manufacturer:

Iberhospitex, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound-nonadherent dressing, absorbent, non-antimicrobial

Manufacturer:

Iberhospitex, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endotracheal tube cuff inflator

Manufacturer:

IDMED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endotracheal tube cuff inflator

Manufacturer:

IDMED

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Neuromuscular transmission lead set

Manufacturer:

IDMED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neuromuscular transmission lead set

Manufacturer:

IDMED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neuromuscular transmission lead set

Manufacturer:

IDMED

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Pupillograph

Manufacturer:

IDMED

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Hand-held electric massager

Manufacturer:

Phoenix Innovative Healthcare Manufacturers Pvt Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Home-use facial steamer

Manufacturer:

Phoenix Innovative Healthcare Manufacturers Pvt Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiographic image marker, manual

Manufacturer:

Polident D.O.O.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic/craniofacial implantation planning software

Manufacturer:

Precision AI Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CD138 cell marker IVD, antibody

Manufacturer:

IQ Products B.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine sediment IVD, control

Manufacturer:

Kova International, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multi-chamber venous compression system garment, reusable

Manufacturer:

DAESUNG MAREF CO.,LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sequential venous compression system

Manufacturer:

DAESUNG MAREF CO.,LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tourniquet cuff, reusable

Manufacturer:

DAESUNG MAREF CO.,LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acetabular shell

Manufacturer:

DEDIENNE SANTE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-constrained polyethylene acetabular liner

Manufacturer:

DEDIENNE SANTE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

DEDIENNE SANTE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam clamp

Manufacturer:

DENTECH CORPORATION

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam frame

Manufacturer:

DENTECH CORPORATION

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam kit

Manufacturer:

DENTECH CORPORATION

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam punch

Manufacturer:

DENTECH CORPORATION

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous administration bag/bottle

Manufacturer:

Diffuplast S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oesophageal bougie, reusable

Manufacturer:

Diversatek Healthcare

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental suction system cannula, single-use

Manufacturer:

Dispotech SRL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Moist-heat pack

Manufacturer:

Dispotech SRL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentine bonding agent/set

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket adhesive

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Silicone dental impression material

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Channelled video intubation laryngoscope

Manufacturer:

PRODOL MEDITEC LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngoscope light-emitting cell

Manufacturer:

PRODOL MEDITEC LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Noninvasive device battery charger

Manufacturer:

PRODOL MEDITEC LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video intubation laryngoscope blade/handle shell

Manufacturer:

PRODOL MEDITEC LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone distraction forceps

Manufacturer:

PSM Pacific Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, reusable

Manufacturer:

PSM Pacific Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, torque-limiting

Manufacturer:

PSM Pacific Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arm procedure positioner, reusable

Manufacturer:

provita medical gmbh & co. Kg

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bowl/basin stand

Manufacturer:

provita medical gmbh & co. Kg

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixed examination/treatment room light

Manufacturer:

provita medical gmbh & co. Kg

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Frame/rail/pole device holder

Manufacturer:

provita medical gmbh & co. Kg

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infusion/transfusion trolley

Manufacturer:

provita medical gmbh & co. Kg

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous pole

Manufacturer:

provita medical gmbh & co. Kg

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual hospital bed

Manufacturer:

provita medical gmbh & co. Kg

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device service rail

Manufacturer:

provita medical gmbh & co. Kg

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental etching solution

Manufacturer:

Pulpdent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Pulpdent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Erthrocyte sedimentation rate (ESR) analyser IVD

Manufacturer:

Alifax S.r.l

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Erthrocyte sedimentation rate (ESR) analyser IVD

Manufacturer:

Alifax S.r.l

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Erythrocyte sedimentation rate (ESR) IVD, calibrator

Manufacturer:

Alifax S.r.l

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Erythrocyte sedimentation rate (ESR) IVD, control

Manufacturer:

Alifax S.r.l

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Alifax S.r.l

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multi-modality clinical specimen analysis system IVD

Manufacturer:

Bloom Diagnostics AG

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Elbow orthosis

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External orthopaedic fixation system, reusable

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot friction/impact protector

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand orthosis

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee support orthosis

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Limb-worn device hygienic cover

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lumbar spine orthosis

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lumbosacral spine orthosis, flexible

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mouthguard, reusable

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple spinal region orthosis

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic insole, prefabricated, non-antimicrobial

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound/centesis drainage receptacle

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound/centesis drainage receptacle

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pleural/peritoneal drainage catheterization kit

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological image marker, implantable

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical tissue/fluid collection bag

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy kit, single-use

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Tracheostomy tube cannula, single-use

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube speech valve

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube, non-reinforced, non-customized, reusable

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, rapid ICT, clinical

Manufacturer:

EIKEN CHEMICAL Co., Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, automated/semi-automated system

Manufacturer:

EIKEN CHEMICAL Co., Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, calibrator

Manufacturer:

EIKEN CHEMICAL Co., Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen collection kit IVD, home-use

Manufacturer:

EIKEN CHEMICAL Co., Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

External lower-limb prosthesis socket, non-customized

Manufacturer:

Coyote O&P, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthosis suspension unit

Manufacturer:

Coyote O&P, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Portable/mobile rechargeable battery pack

Manufacturer:

Choice One Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hearing aid tester, electrical

Manufacturer:

Inventis S.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Impedance audiometer

Manufacturer:

Inventis S.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Back-filling orthosis

Manufacturer:

Allard Support UK Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment/instrument drape, single-use

Manufacturer:

ALLE S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scrub suit, single-use

Manufacturer:

ALLE S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoe cover

Manufacturer:

ALLE S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/examination garment kit

Manufacturer:

ALLE S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis blood tubing set, single-use

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis concentrate

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis needle

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hollow-fibre haemodialysis dialyser, single-use

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hollow-fibre haemodialysis dialyser, single-use

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sodium carbonate haemodialysis system cleaning cartridge

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electric stander/exerciser

Manufacturer:

ATO FORM GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Walking chair, non-foldable

Manufacturer:

ATO FORM GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, reusable

Manufacturer:

Australian Orthopaedic Fixations Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, reusable

Manufacturer:

Australian Orthopaedic Fixations Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arthroscopic shaver system blade, reusable

Manufacturer:

Eberle GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Domestic wiping/brushing/dusting/cleaning assistive device

Manufacturer:

Eberle GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic male condom, Hevea-latex

Manufacturer:

Innolatex (Thailand) Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Innolatex (Thailand) Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Seizure bite block

Manufacturer:

Innovgas Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical eye pressure shield

Manufacturer:

Innovgas Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical eye pressure shield

Manufacturer:

Innovgas Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oral/enteral medicine medicated administration kit, reusable

Manufacturer:

elm-plastic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Enztec Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical power tool adaptor

Manufacturer:

Enztec Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental cotton roll

Manufacturer:

EURONDA S.P.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

EURONDA S.P.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steam sterilizer

Manufacturer:

EURONDA S.P.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilization packaging, single-use

Manufacturer:

EURONDA S.P.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose syringe, single-use

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose syringe/needle

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous administration tubing extension set

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Subcutaneous infusion/injection port needle

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Total reverse shoulder prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cervical total intervertebral disc prosthesis, modular

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Combination-material acetabulum prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cruciate-retaining total knee prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Internal orthopaedic fixation system, cerclage wire/cable, sterile

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile-bearing total knee prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posterior-stabilized total knee prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical countersink, single-use

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical countersink, single-use

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, oscillating, single-use

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Uncoated hip femur prosthesis, modular

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hospital stretcher, manual

Manufacturer:

FAMED Żywiec Sp. z o.o.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual orthopaedic cement mixer, single-use

Manufacturer:

Joline GmbH & CO. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, single-use

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone access cannula

Manufacturer:

Joline GmbH & CO. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Double-lumen haemodialysis catheter, implantable

Manufacturer:

Joline GmbH & CO. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement dispenser

Manufacturer:

Joline GmbH & CO. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stopcock

Manufacturer:

Joline GmbH & CO. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biomechanical function analysis/rehabilitation software

Manufacturer:

JTECH Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dynamometer force gauge

Manufacturer:

JTECH Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand dynamometer/pinchmeter, electronic

Manufacturer:

JTECH Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical networking interface unit

Manufacturer:

JTECH Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pressure algometer, electronic

Manufacturer:

JTECH Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Servicio Integral Hospitalario S.L.U.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

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

Manufacturer:

Servicio Integral Hospitalario S.L.U.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Acetabular shell

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acetabulum prosthesis trial, prefabricated, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Metallic acetabulum prosthesis

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant/instrument assembling device

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infant drinking/feeding cup

Manufacturer:

SINAPI Biomedical (Pty) Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic suction collection container

Manufacturer:

SINAPI Biomedical (Pty) Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulse oximeter probe, single-use

Manufacturer:

Solaris Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flotation therapy bed, adult

Manufacturer:

Span America Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flotation therapy bed, adult

Manufacturer:

Span America Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foam bed mattress

Manufacturer:

Span America Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foam bed mattress

Manufacturer:

Span America Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foam-filled chair cushion

Manufacturer:

Span America Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile patient lifting system, electrically-powered

Manufacturer:

Span America Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile patient lifting system, electrically-powered

Manufacturer:

Span America Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile patient lifting system, electrically-powered

Manufacturer:

Span America Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair back rest

Manufacturer:

Spex Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair seat cushion

Manufacturer:

Spex Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair/chair/stander occupant restraint/support

Manufacturer:

Spex Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oropharyngeal mucosa protection material

Manufacturer:

Medical Brands Developments BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Colour-indication patient thermometer

Manufacturer:

Medical Indicators Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Colour-indication patient thermometer

Manufacturer:

Medical Indicators Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liquid-crystal patient thermometer, reusable

Manufacturer:

Medical Indicators Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liquid-crystal patient thermometer, single-use

Manufacturer:

Medical Indicators Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical video image recorder

Manufacturer:

MediCapture, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical video image recorder

Manufacturer:

MediCapture, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video image processor

Manufacturer:

MediCapture, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oral medicine dropper

Manufacturer:

Meding GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgery fluid retention ring

Manufacturer:

Barron Precision Instruments LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Meditrina Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical tissue/fluid collection bag

Manufacturer:

Meditrina Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

X-ray image interpretive software

Manufacturer:

Qure.ai Technologies Private Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermal curette

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel, single-use

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel, single-use

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin biopsy blade

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin biopsy blade

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneal marker, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneal resection holder, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye muscle hook, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eyeball fixation instrument, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose surgical scissors, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gonioscope

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraocular scissors, conventional-hinge, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Keratoscope, non-powered, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lacrimal dilator, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laser lens, ophthalmic, surgical

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lens loop, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic calliper

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic curette, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic implant handling forceps, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic soft-tissue manipulation forceps, probe-like, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgical incision gauge

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgical probe, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgical probe, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orbital depressor, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Periosteal elevator, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Razor blade breaker/holder

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument guard, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument track identification tape

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical mallet

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Trabeculotomy probe

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vitrectomy contact lens, single-use

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Aneroid manual sphygmomanometer

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ear speculum, reusable

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Head-worn lamp

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous pole

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngoscope blade, reusable

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid endoscope working guide

Manufacturer:

Klaus Wenkert Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-adhesive device retention bandage

Manufacturer:

KOB GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pressure bandage, non-latex, reusable

Manufacturer:

KOB GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pressure bandage, non-latex, single-use

Manufacturer:

KOB GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex surgical glove, non-powdered, non-antimicrobial

Manufacturer:

Kossan International Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental surgical scissors

Manufacturer:

Laschal Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

Millet Innovation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple-joint lower limb orthosis

Manufacturer:

Millet Innovation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scar management dressing, reusable

Manufacturer:

Millet Innovation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wrist/hand orthosis

Manufacturer:

Millet Innovation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical mains power cable

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, single-use

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot-switch, electrical

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hard-tissue ultrasonic surgical system

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hard-tissue ultrasonic surgical system handpiece

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft-tissue ultrasonic surgical system handpiece tip, single-use

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation tubing set, single-use

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical suction system collection container, reusable

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic surgical system handpiece cooling sleeve

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foam-filled chair cushion

Manufacturer:

Motion Concepts

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical cushion cover

Manufacturer:

Motion Concepts

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair bracket

Manufacturer:

Motion Concepts

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair/chair/stander occupant restraint/support

Manufacturer:

Motion Concepts

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental amalgam mixer

Manufacturer:

Motion Dental Equipment Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic plugger

Manufacturer:

Motion Dental Equipment Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device sterilization/disinfection container, reusable

Manufacturer:

MOVMEDIX

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ligament graft, synthetic polymer

Manufacturer:

MOVMEDIX

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant driver

Manufacturer:

MOVMEDIX

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

MOVMEDIX

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

MOVMEDIX

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Manufacturer:

Starface World Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anti-fatigue floor mat

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clamp jaw cover

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clamp jaw cover

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope antifog solution

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope antifog solution

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope working-channel valve, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic bite block, basic, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic bite block, basic, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray corner protector, reusable

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray corner protector, reusable

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray corner protector, reusable

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray cover, reusable

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device cleaning sponge/set

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device disinfection agent

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoe cover

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin marking pen, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument guard, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument guard, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument track identification tape

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/endoscope cleaning utensil, reusable

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/endoscope cleaning utensil, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular booties

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-adhesive device retention bandage

Manufacturer:

Strapit Medical & Sports Supplies Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic suction pump

Manufacturer:

Bearpac Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiation therapy software

Manufacturer:

Limbus AI Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose light source

Manufacturer:

Long Island Technology Group, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Head-worn fibreoptic light

Manufacturer:

Long Island Technology Group, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatoscope, optical

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Direct ophthalmoscope

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Direct ophthalmoscope

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixed examination/treatment room light

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical stethoscope

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anaesthesia face mask, single-use

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Freestanding headrest, reusable

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

In-line CPAP set, nebulizing

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incentive spirometer

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulmonary resuscitator, manual, single-use

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Straight/elbow breathing circuit connector, single-use

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Inflammatory skin/nerve/joint disorder dressing

Manufacturer:

Micreos Human Health B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic electric hospital bed

Manufacturer:

Xiamen Atlantis Mfc Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical apron, single-use

Manufacturer:

ZENMED Tıbbi Cihazlar Ve Sağlık Ürünleri San. Ve Tic. Ltd. Şti.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic intravenous administration set, noninvasive

Manufacturer:

Allmed Middle East

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis system dialysate pyrogen-filtration set

Manufacturer:

Allmed Middle East

Type:

General Medical Device

Registration Date:

Nov 26, 2024

X-ray image interpretive software

Manufacturer:

Artrya Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral angioplasty balloon catheter, basic

Manufacturer:

ARTHESYS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose surgical scissors, single-use

Manufacturer:

B&H Surgical Instrument

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose surgical scissors, single-use

Manufacturer:

B&H Surgical Instrument

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

B&H Surgical Instrument

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheobronchial guidewire

Manufacturer:

bess pro gmbh

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgical drape

Manufacturer:

BETATEX S.p.a

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating room light

Manufacturer:

BihlerMed, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastrointestinal anastomosis coupler, non-bioabsorbable

Manufacturer:

CarpoNovum AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraoperative tumour margin analysis probe

Manufacturer:

Dilon Medical Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraoperative tumour margin analysis probe

Manufacturer:

Dilon Medical Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood plasma freezer

Manufacturer:

FIOCCHETTI SCIENTIFIC S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood refrigerator

Manufacturer:

FIOCCHETTI SCIENTIFIC S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automated lensmeter

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automated ophthalmic refractometer

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneal topography system

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Keratoscope, powered

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic examination slit lamp

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic ultrasound imaging system

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmodiastimeter

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient monitoring system module, data memory

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Perimeter, automatic

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Phacoemulsification/vitrectomy system

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Phoropter

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posterior-chamber intraocular lens, pseudophakic

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posterior-chamber intraocular lens, pseudophakic

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Visual acuity projector

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lacrimal procedural cannula

Manufacturer:

PSI/EYE-KO, Inc. dba Anodyne Surgical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgical probe, single-use

Manufacturer:

PSI/EYE-KO, Inc. dba Anodyne Surgical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Faecal incontinence kit

Manufacturer:

QNQ Design and Development Pvt. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound drain connector

Manufacturer:

Redax S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound/centesis drainage receptacle

Manufacturer:

Redax S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose percutaneous abdominothoracic drainage catheter

Manufacturer:

Redax S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic suction collection container

Manufacturer:

Redax S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mesh-sleeve coronary artery stent

Manufacturer:

Bentley InnoMed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral artery stent, bare-metal

Manufacturer:

Bentley InnoMed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermal tissue reconstructive material, microbe-derived

Manufacturer:

Bohus BioTech AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye lubricant

Manufacturer:

Bohus BioTech AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound-nonadherent dressing, permeable, antimicrobial

Manufacturer:

Hydrofera, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basket endosteal dental implant, two-piece

Manufacturer:

KJ Meditech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic male condom, Hevea-latex

Manufacturer:

Medical-Latex (DUA) Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile basic diagnostic x-ray system, digital

Manufacturer:

Micro-X Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose soft/rigid contact lens solution

Manufacturer:

Schalcon S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixed patient lifting system, manual

Manufacturer:

Nibotechnics nv

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot-switch, electrical

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electromechanical device/system transport trolley

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose light source

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical air low pressure hose

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurosurgical procedure kit, non-medicated, single-use

Manufacturer:

NICO Corporation

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Neurosurgical retraction cannula

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurosurgical retraction cannula manipulation tool

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurosurgical retraction cannula stabilization tool

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurosurgical retraction obturator/probe adaptor

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction/irrigation tubing, single-use

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical probe/cannula bending tool

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical suction system collection container, single-use

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical suction system Y-piece valve-connector

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue morcellation system handpiece, line-powered

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Antimicrobial susceptibility analyser IVD

Manufacturer:

INTELLIGENCE ARTIFICIELLE APPLICATIONS – I2A

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inoculum preparation tool IVD

Manufacturer:

INTELLIGENCE ARTIFICIELLE APPLICATIONS – I2A

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Arm procedure positioner, single-use

Manufacturer:

Tarry Medical Products Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infant-hammock bed mattress overlay

Manufacturer:

Tarry Medical Products Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neonatal positioning/nesting device

Manufacturer:

Tarry Medical Products Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bioabsorbable orthopaedic bone screw

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bioabsorbable orthopaedic bone screw

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone matrix implant, synthetic, non-antimicrobial

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement restrictor sizer

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement, antimicrobial

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tendon/ligament bone anchor, bioabsorbable

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement spacer

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cranioplasty plate, non-alterable

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee revision prosthesis trial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee revision prosthesis trial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement spacer

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement, antimicrobial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement, non-antimicrobial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoulder revision prosthesis trial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic hyperthermia system

Manufacturer:

Theraclion

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic surgical drape

Manufacturer:

TİO MEDİKAL TIBBİ ÜRÜNLER TURİZM İNŞAAT SAN.VE TİC.LTD.ŞTİ.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Headband, reusable

Manufacturer:

Total Healthcare Innovation GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Noninvasive device battery charger

Manufacturer:

Total Healthcare Innovation GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical hood

Manufacturer:

Total Healthcare Innovation GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic appliance relief material

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket, ceramic

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic inter-bracket elastic chain

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic metal band

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic pliers

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic retainer

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic spring

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

United Pacific Industries Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Compression/pressure shirt/pants

Manufacturer:

United Pacific Industries Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elevation arm sling

Manufacturer:

United Pacific Industries Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee support orthosis

Manufacturer:

United Pacific Industries Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoulder immobilizer/orthosis, reusable

Manufacturer:

United Pacific Industries Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing-fixation skin adhesive tape, non-silicone

Manufacturer:

BioDerm, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient medical adhesive remover

Manufacturer:

BioDerm, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Penis wearable urinal

Manufacturer:

BioDerm, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Synthetic-polymer liquid barrier dressing

Manufacturer:

BioDerm, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wearable percutaneous catheter/tube holder

Manufacturer:

BioDerm, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General examination/treatment chair, electric

Manufacturer:

Bionic Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Credo Diagnostics Biomedical Pte. Ltd. Taiwan branch

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, control

Manufacturer:

Credo Diagnostics Biomedical Pte. Ltd. Taiwan branch

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Wheelchair back rest

Manufacturer:

Orthosanit Diffusion S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair head/trunk support, prefabricated

Manufacturer:

Orthosanit Diffusion S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostoma button

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENT surgical procedure kit, non-medicated, reusable

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymeric laryngeal stent

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube speech valve

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

Surestep LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot orthosis

Manufacturer:

Surestep LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic spine orthosis

Manufacturer:

Surestep LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI phantom, test object

Manufacturer:

RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI system application software

Manufacturer:

RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic insole, prefabricated, antimicrobial

Manufacturer:

Foot Science International Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic insole, prefabricated, non-antimicrobial

Manufacturer:

Foot Science International Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound-nonadherent dressing, absorbent, non-antimicrobial

Manufacturer:

T&L Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental cheek retractor, professional, single-use

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eyelid speculum, single-use

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Proctoscope, single-use

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Uterine sound, single-use

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal speculum, single-use

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymeric tracheal/bronchial stent, non-bioabsorbable

Manufacturer:

NOVATECH SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ambulatory non-insulin infusion pump, mechanical, reusable

Manufacturer:

Go Medical Industries Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous administration tubing extension set

Manufacturer:

Go Medical Industries Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posterior-chamber intraocular lens, pseudophakic

Manufacturer:

Hanita Lenses

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

HASS Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic ultraviolet phototherapy solution

Manufacturer:

IROMED GROUP S.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic ultraviolet phototherapy system

Manufacturer:

IROMED GROUP S.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood lancet, single-use

Manufacturer:

J. N. Eberle Federnfabrik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medicated male condom, Hevea-latex

Manufacturer:

Karex Industries Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Aneroid manual sphygmomanometer

Manufacturer:

Koven Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Invasive/noninvasive vascular ultrasound probe

Manufacturer:

Koven Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bladder-supporting pessary

Manufacturer:

Logikal Health Products Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Superficial skin exfoliant, home-use

Manufacturer:

Medical Brands Innovations BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wart-removal cryogenic kit

Manufacturer:

Medical Brands Innovations BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-rechargeable public automated external defibrillator

Manufacturer:

Mediana Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

MEDICALIP Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual blood lancing device, single-use

Manufacturer:

MediPurpose Pte.Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual scalpel blade, single-use

Manufacturer:

MediPurpose Pte.Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anaesthesia breathing circuit, single-use

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anaesthesia breathing circuit, single-use

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heat/moisture exchanger/microbial medical gas filter

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical utensil washer/disinfector

Manufacturer:

MELAG Medizintechnik GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic apex locator

Manufacturer:

META SYSTEMS CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic dental scaling/debridement system

Manufacturer:

META SYSTEMS CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acupuncture needle, single-use

Manufacturer:

NEO Dr. INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Manufacturer:

NEO Dr. INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Epiretinal/inner limiting membrane scraper, single-use

Manufacturer:

Peregrine Surgical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foetal cardiac monitor

Manufacturer:

Bistos Co., Ltd.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

General-purpose multi-parameter bedside monitor

Manufacturer:

Bistos Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bunion shield

Manufacturer:

Millet Innovation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hallux valgus metatarsophalangeal orthosis

Manufacturer:

Millet Innovation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee/ankle/foot orthosis

Manufacturer:

Millet Innovation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic insole, prefabricated, non-antimicrobial

Manufacturer:

Millet Innovation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pressure-management bandage, silicone

Manufacturer:

Millet Innovation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pressure-management bandage, silicone

Manufacturer:

Millet Innovation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electromechanical device/system transport trolley

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical cable adaptor

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft-tissue ultrasonic surgical system handpiece, reusable

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical suction system collection container, reusable

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic surgical system generator

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic surgical system handpiece cooling sleeve

Manufacturer:

Misonix Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Alarm application software

Manufacturer:

MN Santé Holding

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair back rest

Manufacturer:

Motion Concepts

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair head/trunk support, prefabricated

Manufacturer:

Motion Concepts

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

MOVMEDIX

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

MOVMEDIX

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tendon/ligament bone anchor, non-bioabsorbable

Manufacturer:

MOVMEDIX

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tendon/ligament tunneller

Manufacturer:

MOVMEDIX

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wire/ligature passer, reusable

Manufacturer:

MOVMEDIX

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Overhead track patient lifting/transfer system

Manufacturer:

Savaria Concord Lifts inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acetabular orthopaedic reamer

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-constrained polyethylene acetabular liner

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant/instrument assembling device

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intrauterine haemostatic balloon catheter

Manufacturer:

SINAPI Biomedical (Pty) Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical suction system collection container, single-use

Manufacturer:

SINAPI Biomedical (Pty) Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Erythrocyte sedimentation rate (ESR) IVD, control

Manufacturer:

Alifax S.r.l

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory shaker IVD

Manufacturer:

Alifax S.r.l

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Erythrocyte sedimentation rate (ESR) IVD, calibrator

Manufacturer:

Alifax S.r.l

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hot/cold therapy pack, reusable

Manufacturer:

Dispotech SRL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bib/apron, adult, single-use

Manufacturer:

Dispotech SRL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin kit

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Metallic femoral head prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Reverse shoulder prosthesis base plate

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tendon/ligament bone anchor, non-bioabsorbable

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arthroscopic irrigation/insufflation system

Manufacturer:

Eberle GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arthroscopic shaver system blade, single-use

Manufacturer:

Eberle GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone trephine set

Manufacturer:

Eberle GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medicine cup, reusable

Manufacturer:

elm-plastic GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone hook

Manufacturer:

Enztec Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held surgical retractor, reusable

Manufacturer:

Enztec Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

Enztec Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical ruler, reusable

Manufacturer:

Enztec Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

Enztec Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant-instrument extension adaptor, reusable

Manufacturer:

Enztec Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic spirit level

Manufacturer:

Enztec Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Enztec Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental suction system cannula, reusable

Manufacturer:

EURONDA S.P.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, single-use

Manufacturer:

EURONDA S.P.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Head-worn lamp

Manufacturer:

Long Island Technology Group, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Noninvasive device battery charger

Manufacturer:

Long Island Technology Group, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Portable active medical device mount

Manufacturer:

Long Island Technology Group, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical video camera

Manufacturer:

Long Island Technology Group, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile examination/treatment room light

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile examination/treatment room light

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Otoscope, direct

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percussion hammer, manual, reusable

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid intubation laryngoscope, reusable

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid intubation laryngoscope, reusable

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tuning fork

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tuning fork

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastrointestinal gas suppressant

Manufacturer:

Medical Brands Developments BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nail infection solution

Manufacturer:

Medical Brands Developments BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal pH suppository

Manufacturer:

Medical Brands Developments BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liquid-crystal patient thermometer, reusable

Manufacturer:

Medical Indicators Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Liquid-crystal patient thermometer, single-use

Manufacturer:

Medical Indicators Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Image display unit, colour

Manufacturer:

MediCapture, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Image display unit, colour

Manufacturer:

MediCapture, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video image processor

Manufacturer:

MediCapture, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medicine spoon, single-use

Manufacturer:

Meding GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood collection set, invasive

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood collection set, invasive

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental syringe needle, single-use

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermal curette

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Insulin syringe/needle, basic

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral intravenous cannula

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pressure bandage, Hevea-latex, single-use

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel, single-use

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter introduction needle

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lumbar total intervertebral disc prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arthrodesis nail, fixed-length

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ceramic acetabular liner

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ceramic femoral head prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Coated shoulder humeral stem prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixed-bearing total ankle prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Humerus nail

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Universal operating table, electromechanical

Manufacturer:

FAMED Żywiec Sp. z o.o.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Universal operating table, electromechanical

Manufacturer:

FAMED Żywiec Sp. z o.o.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic instrument chairside holder set

Manufacturer:

Jordco, Inc

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Endodontic instrument identification tag

Manufacturer:

Jordco, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Balloon kyphoplasty kit

Manufacturer:

Joline GmbH & CO. KG

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Double-lumen haemodialysis catheter, nonimplantable

Manufacturer:

Joline GmbH & CO. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose syringe, single-use

Manufacturer:

Joline GmbH & CO. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual orthopaedic cement mixer, single-use

Manufacturer:

Joline GmbH & CO. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Triple-lumen haemodialysis catheter

Manufacturer:

Joline GmbH & CO. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Joint/spinal manipulator, mechanical

Manufacturer:

JTECH Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Core body stabilization/exercise stool

Manufacturer:

Kaye Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneal scissors, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneal trephine handle

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Craniofacial rongeur, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing/utility forceps, scissors-like, single-use

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing/utility forceps, tweezers-like, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Enucleation scissors, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eyelid clamp, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flieringa ophthalmic ring

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraocular scissors, probe-like, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lacrimal punctum plug

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lacrimal tube insertion hook/pusher

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lens spoon

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal speculum, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic diagnostic condensing lens

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic sponge

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic strabismus scissors, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic suture scissors

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic tonometer, manual

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orbital sphere implant introducer

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Periocular/lacrimal retractor, hand-held, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical eye pressure shield

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing needle holder, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Direct ophthalmoscope

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing/utility forceps, tweezers-like, reusable

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hyperhidrosis iontophoresis system

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngoscope handle, single-use

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Noninvasive device battery charger

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Otoscope, direct

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal dilator

Manufacturer:

RR Medical s.r.o.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Moist-cold pressure bandage

Manufacturer:

KOB GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Kossan International Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Kossan International Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue specimen x-ray system

Manufacturer:

KUB TECHNOLOGIES, INC. dba KUBTEC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, kit, rapid ICT, clinical

Manufacturer:

Bloom Diagnostics AG

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, kit, rapid ICT, clinical

Manufacturer:

Bloom Diagnostics AG

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Surgical instrument/endoscope cleaning utensil, single-use

Manufacturer:

PriMed Instruments Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clavicle orthosis

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand/finger splint, reusable

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip orthosis

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoulder immobilizer/orthosis, reusable

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-cover adhesive strip, non-antimicrobial

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic spine orthosis

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracolumbosacral spine orthosis, rigid

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wrist/hand orthosis

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound drainage kit

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heat/moisture exchanger, single-use

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mediastinal drainage catheter, non-antimicrobial

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction/irrigation tubing, single-use

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy kit, single-use

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Tracheostomy kit, single-use

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube, non-reinforced, non-customized, reusable

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, reagent

Manufacturer:

EIKEN CHEMICAL Co., Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, control

Manufacturer:

EIKEN CHEMICAL Co., Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Corneal punch set

Manufacturer:

Barron Precision Instruments LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneal resection holder, single-use

Manufacturer:

Barron Precision Instruments LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneal trephine, single-use

Manufacturer:

Barron Precision Instruments LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid video hysteroscope

Manufacturer:

Meditrina Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation/aspiration tubing set

Manufacturer:

Meditrina Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue morcellation system control unit

Manufacturer:

Meditrina Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue morcellation system handpiece, line-powered

Manufacturer:

Meditrina Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transportable medical equipment stand, non-powered

Manufacturer:

Meditrina Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

X-ray image interpretive software

Manufacturer:

Qure.ai Technologies Private Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient surgical drape, single-use

Manufacturer:

Raguse Gesellschaft für medizinische Produkte mbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiation therapy software

Manufacturer:

Radiological Imaging Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Commode, manual

Manufacturer:

Raz Design Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual scalpel blade, single-use

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual scalpel blade, single-use

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel handle, reusable

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suture cutter, single-use

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

RealCloud Imaging Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Airway pressure monitor, non-powered

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CPAP/BPAP nasal mask, single-use

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Exhaled-gas oesophageal intubation detector, paediatric

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulmonary resuscitator, pneumatic, single-use

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resuscitator face mask, reusable

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient surgical drape, single-use

Manufacturer:

MHK MEDIKAL TEKSTIL SAN. TIC. LTD. STI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical apron, single-use

Manufacturer:

MHK MEDIKAL TEKSTIL SAN. TIC. LTD. STI

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Seizure bite block

Manufacturer:

Innovgas Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Densitometry body composition analyser

Manufacturer:

COSMED USA, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Circulating-fluid thermal therapy system pack, reusable

Manufacturer:

DAESUNG MAREF CO.,LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-chamber venous compression system garment, single-use

Manufacturer:

DAESUNG MAREF CO.,LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sequential venous compression system pump

Manufacturer:

DAESUNG MAREF CO.,LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acetabular orthopaedic reamer

Manufacturer:

DEDIENNE SANTE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acetabulum prosthesis trial, prefabricated, reusable

Manufacturer:

DEDIENNE SANTE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam, Hevea-latex

Manufacturer:

DENTECH CORPORATION

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam, non-latex

Manufacturer:

DENTECH CORPORATION

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CD103 cell marker IVD, antibody

Manufacturer:

IQ Products B.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Foeto-maternal haemorrhage/Kleihauer test IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

Manufacturer:

IQ Products B.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser specimen/reagent container carrier IVD

Manufacturer:

LP ITALIANA SPA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pipette tip IVD

Manufacturer:

LP ITALIANA SPA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dried blood spot collection receptacle IVD

Manufacturer:

Trajan Scientific Australia Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electroencephalographic electrode cap, single-use

Manufacturer:

Hurev Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye mask

Manufacturer:

Hurricane Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye mask

Manufacturer:

Hurricane Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic sponge

Manufacturer:

Hurricane Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin marking pen, single-use

Manufacturer:

Hurricane Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental elevator, tooth/root

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, reusable

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray, reusable

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device sterilization/disinfection container, reusable

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held surgical retractor, reusable

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual dental scaler, reusable

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual non-rotary dental instrument handle

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone-fragment manipulator, single-use, non-sterile

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implantation hammering attachment

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/examination garment kit

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tooth extraction forceps

Manufacturer:

HYGITECH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Antimicrobial synthetic polymer semi-permeable film dressing, adhesive

Manufacturer:

Iberhospitex, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound drainage kit

Manufacturer:

Iberhospitex, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Coronary angioplasty balloon catheter, basic

Manufacturer:

Iberhospitex, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

Manufacturer:

Iberhospitex, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular guide-catheter, single-use

Manufacturer:

Iberhospitex, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wearable percutaneous catheter/tube holder

Manufacturer:

Iberhospitex, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endotracheal tube cuff inflator

Manufacturer:

IDMED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neuromuscular transmission lead set

Manufacturer:

IDMED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Camera application software

Manufacturer:

PRODOL MEDITEC LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Camera application software

Manufacturer:

PRODOL MEDITEC LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Channelled video intubation laryngoscope

Manufacturer:

PRODOL MEDITEC LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngoscope light-emitting cell

Manufacturer:

PRODOL MEDITEC LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video intubation laryngoscope blade/handle shell

Manufacturer:

PRODOL MEDITEC LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video intubation laryngoscope imaging system

Manufacturer:

PRODOL MEDITEC LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gas cylinder holder

Manufacturer:

provita medical gmbh & co. Kg

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

Pulpdent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental etching solution

Manufacturer:

Pulpdent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material injection cannula, single-use

Manufacturer:

Pulpdent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material mixing nozzle

Manufacturer:

Pulpdent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental matrix band, single-use

Manufacturer:

Pulpdent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental mirror, reusable

Manufacturer:

Pulpdent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Audiometric/hearing aid tester

Manufacturer:

Inventis S.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tone audiometer

Manufacturer:

Inventis S.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual scalpel blade, single-use

Manufacturer:

Jai Surgicals Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel handle, reusable

Manufacturer:

Jai Surgicals Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suture cutter, single-use

Manufacturer:

Jai Surgicals Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Solaris Medical Technology, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foam-filled chair cushion

Manufacturer:

Span America Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gel-filled chair cushion

Manufacturer:

Span America Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gel-filled chair cushion

Manufacturer:

Span America Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile patient lifting system, electrically-powered

Manufacturer:

Span America Medical Systems, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair armrest

Manufacturer:

Spex Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair head/trunk support, prefabricated

Manufacturer:

Spex Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair headrest

Manufacturer:

Spex Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient medical adhesive remover

Manufacturer:

Archy Medical B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual blood lancing device, reusable

Manufacturer:

Phoenix Innovative Healthcare Manufacturers Pvt Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steam inhaler, electrically-powered

Manufacturer:

Phoenix Innovative Healthcare Manufacturers Pvt Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

Polident D.O.O.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Custom-made orthopaedic/craniofacial surgical guide

Manufacturer:

Precision AI Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic helmet

Manufacturer:

ATO FORM GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Australian Orthopaedic Fixations Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device cleaning/disinfection wipe

Manufacturer:

Choice One Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anti-fatigue floor mat

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clamp jaw cover

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clamp jaw cover

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device operating status label/tag, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device operating status label/tag, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical tip cleaning pad

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope working-channel valve, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic bite block, basic, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument hygienic-transportation bag

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument hygienic-transportation bag

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray cover, reusable

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoe cover

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin marking pen, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin marking pen, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilization container mat

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument track identification tape

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/endoscope cleaning utensil, reusable

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/endoscope cleaning utensil, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical vessel loop

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical vessel loop

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular booties

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular booties

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Venous tourniquet, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Venous tourniquet, single-use

Manufacturer:

Batrik Medical Manufacturing Inc. also dba as 7343591 Canada Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pleural/peritoneal drainage catheterization kit

Manufacturer:

Bearpac Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic suction pump

Manufacturer:

Bearpac Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing-fixation skin adhesive tape, non-silicone

Manufacturer:

Strapit Medical & Sports Supplies Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee support orthosis

Manufacturer:

Surestep LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI system application software

Manufacturer:

RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anaesthesia face mask, single-use

Manufacturer:

Foremount Enterprise., Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anaesthesia mask strap, single-use

Manufacturer:

Foremount Enterprise., Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngoscope blade, single-use

Manufacturer:

Foremount Enterprise., Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oropharyngeal airway, single-use

Manufacturer:

Foremount Enterprise., Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SW Sustainability Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polychloroprene examination/treatment glove, non-powdered

Manufacturer:

SW Sustainability Solutions Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient surgical drape, single-use

Manufacturer:

ALLE S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

Allard Support UK Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Back-filling orthosis

Manufacturer:

Allard Support UK Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip orthosis

Manufacturer:

Allard Support UK Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Isolation gown, single-use

Manufacturer:

ALLE S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction/irrigation tubing, single-use

Manufacturer:

ALLE S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical gown, single-use

Manufacturer:

ALLE S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical gown, single-use

Manufacturer:

ALLE S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/examination garment kit

Manufacturer:

ALLE S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis system dialysate pyrogen filter

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient surgical drape, single-use

Manufacturer:

ZENMED Tıbbi Cihazlar Ve Sağlık Ürünleri San. Ve Tic. Ltd. Şti.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel, single-use

Manufacturer:

Aditya Dispomed Products Private Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis concentrate

Manufacturer:

Allmed Middle East

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis system dialysate pyrogen filter

Manufacturer:

Allmed Middle East

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemostasis valve

Manufacturer:

ARTHESYS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thrombectomy suction catheter

Manufacturer:

ARTHESYS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental delivery system

Manufacturer:

Aseptico Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic filling material condenser

Manufacturer:

Aseptico Inc.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Dressing/utility forceps, tweezers-like, reusable

Manufacturer:

B&H Surgical Instrument

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal tracheal/bronchial stent

Manufacturer:

bess pro gmbh

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BETATEX S.p.a

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical suction pump

Manufacturer:

CHEIRÓN a.s.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental x-ray film, non-screen

Manufacturer:

DENTAL FILM S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manometric gastrointestinal motility analysis system

Manufacturer:

Diversatek Healthcare, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breast pump, electric

Manufacturer:

Bistos Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foetal Doppler system

Manufacturer:

Bistos Co., Ltd.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Pulse oximeter

Manufacturer:

Bistos Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical suction system collection container, single-use

Manufacturer:

BLS Systems

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General cryosurgical system, cryogen gas, mechanical

Manufacturer:

RecensMedical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Autotransfusion system blood component processing set

Manufacturer:

Redax S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound drain, non-bioabsorbable

Manufacturer:

Redax S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pleural drainage valve

Manufacturer:

Redax S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic suction pump

Manufacturer:

Redax S.p.A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal aortic stent

Manufacturer:

Bentley InnoMed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Iliac artery stent, bare-metal

Manufacturer:

Bentley InnoMed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Iliofemoral vein stent

Manufacturer:

Bentley InnoMed GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

KJ Meditech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic anchoring screw

Manufacturer:

KJ Meditech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic male condom, Hevea-latex

Manufacturer:

Nulatex Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Manufacturer:

T&L Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Manufacturer:

T&L Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device sterilization/disinfection container, reusable

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical mains power cable

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurosurgical procedure kit, non-medicated, reusable

Manufacturer:

NICO Corporation

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Neurosurgical retraction obturator

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue morcellation system tissue preservation container

Manufacturer:

NICO Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flotation therapy bed, neonatal

Manufacturer:

Tarry Medical Products Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement spacer

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tap, reusable

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement dispenser

Manufacturer:

TEKNIMED SAS

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Orthopaedic cement, non-antimicrobial

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vertebral bone filler, non-bioabsorbable

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone matrix implant, synthetic, non-antimicrobial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Femoral canal sponge

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip revision prosthesis trial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip revision prosthesis trial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement mixing container, single-use

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement spacer

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement-chilling device

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement, non-antimicrobial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement/bone filler dispensing gun

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer orthopaedic cement restrictor, non-bioabsorbable

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer orthopaedic cement restrictor, non-bioabsorbable

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Powered orthopaedic cement mixer

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Segmented orthopaedic cement extraction rod

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoulder revision prosthesis trial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic hyperthermia system

Manufacturer:

Theraclion

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient surgical drape, single-use

Manufacturer:

TİO MEDİKAL TIBBİ ÜRÜNLER TURİZM İNŞAAT SAN.VE TİC.LTD.ŞTİ.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical apron, single-use

Manufacturer:

TİO MEDİKAL TIBBİ ÜRÜNLER TURİZM İNŞAAT SAN.VE TİC.LTD.ŞTİ.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical helmet system

Manufacturer:

Total Healthcare Innovation GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket adhesive

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic inter-arch elastic band

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic power arm

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic separator

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic tube

Manufacturer:

TP Orthodontics, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

First aid absorbent pad/bandage

Manufacturer:

TyTek Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body aspiration needle, single-use

Manufacturer:

TyTek Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Portable stretcher

Manufacturer:

TyTek Medical

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cervical spine collar, reusable

Manufacturer:

United Pacific Industries Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wrist/hand orthosis

Manufacturer:

United Pacific Industries Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Reinforced endotracheal tube, single-use

Manufacturer:

Venner Medical (Singapore) Pte Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Venner Medical (Singapore) Pte Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biomechanical function analysis/rehabilitation software

Manufacturer:

Bio-Sensing Solutions S.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urinary incontinence penis sheath/port, single-use

Manufacturer:

BioDerm, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis chair, electric

Manufacturer:

Bionic Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bed/chair electric massager

Manufacturer:

Wellness Nordic A/S

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Credo Diagnostics Biomedical Pte. Ltd. Taiwan branch

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A/B virus nucleic acid IVD, control

Manufacturer:

Credo Diagnostics Biomedical Pte. Ltd. Taiwan branch

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Credo Diagnostics Biomedical Pte. Ltd. Taiwan branch

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) nucleic acid IVD, control

Manufacturer:

Credo Diagnostics Biomedical Pte. Ltd. Taiwan branch

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coronary angioplasty balloon catheter, basic

Manufacturer:

BrosMed Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radial artery compression device

Manufacturer:

BrosMed Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Attendant-only-propelled wheelchair, non-bariatric

Manufacturer:

BRUMABA GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Universal operating table, hydraulic

Manufacturer:

BRUMABA GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee support orthosis

Manufacturer:

Camp Scandinavia AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic insole, prefabricated, non-antimicrobial

Manufacturer:

Camp Scandinavia AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wrist/hand orthosis

Manufacturer:

Camp Scandinavia AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Circulating-air whole-body heating/cooling system pad, single-use, sterile

Manufacturer:

Care Essentials Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood storage solution, freezing

Manufacturer:

OriGen Biomedical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood transfer set

Manufacturer:

OriGen Biomedical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood/tissue storage/culture container

Manufacturer:

OriGen Biomedical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluid transfer set, general-purpose

Manufacturer:

OriGen Biomedical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Preformed vocal cord medialization implant

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suture retention device

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Trachea prosthesis

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostoma button

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube cannula, reusable

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube, non-reinforced, non-customized, reusable

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ear speculum, single-use

Manufacturer:

Hammarplast Medical AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Examination/operating table component trolley

Manufacturer:

Grouleff Medical ApS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood refrigerator/freezer

Manufacturer:

FIOCCHETTI SCIENTIFIC S.R.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental delivery system instrument unit, electric

Manufacturer:

Foshan Nanhai ZIANN Medical Apparatus Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneal topography system

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye anterior segment analyser

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye anterior segment analyser software

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gonioscope

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Keratoscope, powered

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic examination slit lamp

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic tonometer, line-powered

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic tonometer, line-powered

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posterior eye segment analyser software

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Retinal image analysis software

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasound pachymeter

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Examination/treatment table, line-powered

Manufacturer:

NİTROCARE MEDİKAL MOBİLYA SANAYİ VE TİCARET ANONİM ŞİRKETİ

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biofeedback system application software

Manufacturer:

Noraxon USA, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Kinesiology/electromyographic sensor set

Manufacturer:

Noraxon USA, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Kinesiology/electromyographic sensor set

Manufacturer:

Noraxon USA, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Abdominal/ENT/orthopaedic surgical probe, single-use

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ear speculum, single-use

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endaural surgical curette, single-use

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixed-diameter cervical dilator, single-use

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulmonary function testing filter/mouthpiece

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

NORTH EOS INDUSTRIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endotracheal tube introducer, reusable

Manufacturer:

NOVATECH SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pleural talc

Manufacturer:

NOVATECH SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid bronchoscope

Manufacturer:

NOVATECH SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheobronchial suction/insufflation catheter, single-lumen

Manufacturer:

NOVATECH SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oxygen administration enhancement device

Manufacturer:

GMMI Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Noninvasive vascular ultrasound system

Manufacturer:

Hadeco, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual intraocular lens injector, single-use

Manufacturer:

Hanita Lenses

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter introduction set, nonimplantable

Manufacturer:

intra special catheters GmbH

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Vascular catheterization support/maintenance kit, non-medicated

Manufacturer:

intra special catheters GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis needle

Manufacturer:

JMS Singapore Pte Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis needle

Manufacturer:

JMS Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Karex Industries Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sexual lubricant

Manufacturer:

Karex Industries Sdn. Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Inhalation therapy saline solution, isotonic

Manufacturer:

Legency Remedies Private Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Root canal cleaning solution

Manufacturer:

Magnum Dental OÜ

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-rechargeable professional semi-automated external defibrillator

Manufacturer:

Mediana Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-rechargeable public semi-automated external defibrillator

Manufacturer:

Mediana Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physiologic-monitoring defibrillation system

Manufacturer:

Mediana Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breathing circuit bag, single-use

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breathing circuit catheter mount, single-use

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heat/moisture exchanger/microbial filter, sterile

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microbial medical gas filter, single-use

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microbial medical gas filter, single-use

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ventilator breathing circuit, single-use

Manufacturer:

Meditera Tıbbi Malzeme Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steam sterilizer

Manufacturer:

MELAG Medizintechnik GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steam sterilizer

Manufacturer:

MELAG Medizintechnik GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental casting non-noble alloy

Manufacturer:

Mesa Italia S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental soldering alloy

Manufacturer:

Mesa Italia S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental surgical power tool motorized handpiece/set, electric

Manufacturer:

META SYSTEMS CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic obturation system

Manufacturer:

META SYSTEMS CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic fibreoptic light instrument, single-use

Manufacturer:

Peregrine Surgical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acupuncture needle, single-use

Manufacturer:

NEO Dr. INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-body orifice lubricant

Manufacturer:

Pharmazeutische Fabrik Montavit Gesellschaft m.b.H.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-body orifice lubricant

Manufacturer:

Pharmazeutische Fabrik Montavit Gesellschaft m.b.H.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bathing stretcher

Manufacturer:

Howard Wright Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose stereotactic surgery system

Manufacturer:

CASCINATION AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology picture archiving and communication system workstation

Manufacturer:

CASCINATION AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology picture archiving and communication system workstation

Manufacturer:

CASCINATION AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical optical-tracking spatial marker, single-use

Manufacturer:

CASCINATION AG

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Push-rim manual wheelchair, bariatric

Manufacturer:

PDG Product Design Group Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological general body-part positioner

Manufacturer:

Pearl Technology AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological headrest

Manufacturer:

Pearl Technology AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENFit oral/enteral syringe, reusable

Manufacturer:

PENTAFERTE ITALIA s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Enteral feeding noninvasive-component set

Manufacturer:

PENTAFERTE ITALIA s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose syringe, single-use

Manufacturer:

PENTAFERTE ITALIA s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

PENTAFERTE ITALIA s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Circulating-fluid localized thermal/compression therapy system control unit

Manufacturer:

DAESUNG MAREF CO.,LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Circulating-fluid thermal therapy system pack, single-use

Manufacturer:

DAESUNG MAREF CO.,LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

DEDIENNE SANTE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

DEDIENNE SANTE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam clamp forceps

Manufacturer:

DENTECH CORPORATION

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nail infection solution

Manufacturer:

Medical Brands Developments BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Colour-indication patient thermometer

Manufacturer:

Medical Indicators Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Colour-indication patient thermometer

Manufacturer:

Medical Indicators Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medicine cup, single-use

Manufacturer:

Meding GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental suction system cannula, single-use

Manufacturer:

EURONDA S.P.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

EURONDA S.P.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hot/cold therapy pack, single-use

Manufacturer:

EURONDA S.P.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Artificial saliva

Manufacturer:

Europharma Concepts Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rib/sternum binder, single-use

Manufacturer:

Evangelos Ignatios Koutris Greek Cardiothoracic Support (GCS)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic intravenous administration set, noninvasive

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hypodermic needle, single-use

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual scalpel blade, single-use

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-coring punch, single-use

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal needle, single-use

Manufacturer:

Exelint International Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acetabular shell

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Coated hip femur prosthesis, modular

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixed-bearing total ankle prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-constrained polyethylene acetabular liner

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone washer, sterile

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic/craniofacial implantation planning software

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stem-fixed humeral head prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilization container mat

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Total shoulder prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Uncoated shoulder humeral stem prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic electric hospital bed

Manufacturer:

FAMED Żywiec Sp. z o.o.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Overhead track patient lifting/transfer system

Manufacturer:

Savaria Concord Lifts inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Servicio Integral Hospitalario S.L.U.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

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

Manufacturer:

Servicio Integral Hospitalario S.L.U.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acetabular shell

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implant impactor, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical depth gauge, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant/trial-implant/sizer holder, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical torque wrench, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical torque wrench, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple Candida/yeast species culture isolate identification IVD, kit

Manufacturer:

Alifax S.r.l

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Alifax S.r.l

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Alifax S.r.l

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cold/cool therapy spray

Manufacturer:

Dispotech SRL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental cotton roll

Manufacturer:

Dispotech SRL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endothermic cold therapy pack

Manufacturer:

Dispotech SRL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Examination/treatment table paper

Manufacturer:

Dispotech SRL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilization packaging, single-use

Manufacturer:

Dispotech SRL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin kit

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental etching solution

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive powder

Manufacturer:

Pulpdent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical support tape, non-bioabsorbable

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic instrument chairside holder set

Manufacturer:

Jordco, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic instrument-holding insert, single-use

Manufacturer:

Jordco, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical ruler, reusable

Manufacturer:

Jordco, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biopsy drill bit

Manufacturer:

Joline GmbH & CO. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone biopsy needle

Manufacturer:

Joline GmbH & CO. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone curette, single-use

Manufacturer:

Joline GmbH & CO. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tunnel plug, cannulated

Manufacturer:

Joline GmbH & CO. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cannulated surgical drill guiding pin

Manufacturer:

Joline GmbH & CO. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Kyphoplasty balloon catheter

Manufacturer:

Joline GmbH & CO. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electronic goniometer/kinesiology sensor

Manufacturer:

JTECH Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Handgrip disability-assistive walker, non-powered, foldable

Manufacturer:

Kaye Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneal trephine, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneoscleral punch

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye spud

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eyelid speculum, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eyelid speculum, single-use

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraocular lens removal scissors, conventional-hinge, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Luer/non-ISO80369-standardized linear connector, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual intraocular lens injector, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal chisel

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic knife, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic needle, single-use

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel handle, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scleral marker, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scleral plug, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing needle, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Towel clamp, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vitrectomy sutureless lens holding ring, single-use

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bunion shield

Manufacturer:

PRIM, S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Aneroid manual sphygmomanometer

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bandage scissors, reusable

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic power supply, reusable

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood pressure cuff, reusable

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood pressure cuff, single-use

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatoscope, optical

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held examination/treatment light

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngoscope blade, single-use

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngoscope handle, reusable

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical stethoscope

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile examination/treatment room light

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tuning fork

Manufacturer:

KIRCHNER & WILHELM GmbH + Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pressure bandage, Hevea-latex, single-use

Manufacturer:

KOB GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Kossan International Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex surgical glove, non-powdered, non-antimicrobial

Manufacturer:

Kossan International Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Kossan International Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing/utility forceps, scissors-like, reusable

Manufacturer:

Laschal Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose surgical scissors, reusable

Manufacturer:

Laschal Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suture scissors

Manufacturer:

Laschal Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing needle holder, reusable

Manufacturer:

Laschal Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bunion shield

Manufacturer:

Millet Innovation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hallux valgus metatarsophalangeal orthosis

Manufacturer:

Millet Innovation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic insole, prefabricated, non-antimicrobial

Manufacturer:

Millet Innovation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scar management dressing, reusable

Manufacturer:

Millet Innovation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wrist/hand orthosis

Manufacturer:

Millet Innovation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Seasonal affective disorder phototherapy unit

Manufacturer:

SMR Automotive Australia Pty Limited

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Ophthalmic ultrasound imaging system

Manufacturer:

Sonomed, Inc

Type:

General Medical Device

Registration Date:

Nov 22, 2024

LED dental light, line-powered

Manufacturer:

Motion Dental Equipment Corporation

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Skin-cover adhesive strip, non-antimicrobial

Manufacturer:

CMC Consumer Medical Care GmbH

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Bar dental precision attachment

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dental bridge, polymer

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Cognitive assessment software

Manufacturer:

ImPACT Applications, Inc.

Type:

General Medical Device

Registration Date:

Nov 22, 2024

External lower-limb prosthesis suspensory component, non-powered

Manufacturer:

Cypress Adaptive LLC

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Infant resuscitation table

Manufacturer:

Concord Neonatal BV

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dental bridge, polymer

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dental bridge, metal-ceramic

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Bar dental precision attachment

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Bar dental precision attachment

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dental implant suprastructure, temporary, preformed, reusable

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Surgical drill guide, single-use

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Root canal post, preformed

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dental polishing cup, single-use

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Root canal post, preformed

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dental articulation paste/solution

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dental prosthesis-component adhesive

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Instrument tray, reusable

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Surgical screwdriver, single-use

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

LED dental light, battery-powered

Manufacturer:

Motion Dental Equipment Corporation

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Blue light radiometer

Manufacturer:

Motion Dental Equipment Corporation

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Cardiac electrophysiology stimulation system

Manufacturer:

Micropace Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Programmable ambulation exoskeleton, clinical

Manufacturer:

Rewalk Robotics Ltd.

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Surgical screwdriver, reusable

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dental torque wrench

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dental prosthesis-component adhesive

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dental prosthesis veneer resin

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dental bridge, ceramic

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Examination/treatment table, line-powered

Manufacturer:

FAMED Żywiec Sp. z o.o.

Type:

General Medical Device

Registration Date:

Nov 15, 2024

Guidewire-retention prevention box

Manufacturer:

Venner Medical (Singapore) Pte Ltd.

Type:

General Medical Device

Registration Date:

Nov 10, 2024

Perineometer

Manufacturer:

JUNOFEM LIMITED

Type:

General Medical Device

Registration Date:

Nov 10, 2024

Wound-nonadherent dressing, absorbent, non-antimicrobial

Manufacturer:

Iberhospitex, S.A.

Type:

General Medical Device

Registration Date:

Nov 10, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Orthopaedic cement spacer

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Nov 1, 2024

Closed-wound drainage kit

Manufacturer:

Medinorm Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Oct 13, 2024

Closed-wound drain, non-bioabsorbable

Manufacturer:

Medinorm Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Oct 13, 2024

Closed-wound drain connector

Manufacturer:

Medinorm Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Oct 13, 2024

Endoscopic video image processing unit

Manufacturer:

MediCapture, Inc.

Type:

General Medical Device

Registration Date:

Oct 9, 2024

General specimen collection kit

Manufacturer:

KOLPLAST CI SA

Type:

General Medical Device

Registration Date:

Oct 4, 2024

Portable stretcher

Manufacturer:

Frestems Oy

Type:

General Medical Device

Registration Date:

Oct 4, 2024

Colour-indication patient thermometer

Manufacturer:

Medical Indicators Inc

Type:

General Medical Device

Registration Date:

Sep 29, 2024

Cardiac/peripheral vascular guidewire, single-use

Manufacturer:

SP Medical A/S

Type:

General Medical Device

Registration Date:

Sep 29, 2024

Colour-indication patient thermometer

Manufacturer:

Medical Indicators Inc

Type:

General Medical Device

Registration Date:

Sep 29, 2024

Partial denture

Manufacturer:

gebdi DENTAL-PRODUCTS GmbH

Type:

General Medical Device

Registration Date:

Sep 29, 2024

Peripheral vascular guidewire, manual

Manufacturer:

SP Medical A/S

Type:

General Medical Device

Registration Date:

Sep 29, 2024

Liquid-crystal patient thermometer, single-use

Manufacturer:

Medical Indicators Inc

Type:

General Medical Device

Registration Date:

Sep 29, 2024

Gastro-urological guidewire, single-use

Manufacturer:

SP Medical A/S

Type:

General Medical Device

Registration Date:

Sep 29, 2024

Orthopaedic prosthesis implantation positioning instrument, single-use

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Tracheostoma button

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Tracheostoma button

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Tracheostomy tube cannula, reusable

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Hypoallergenic skin adhesive tape

Manufacturer:

Hurricane Medical

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Closed-wound drain, non-bioabsorbable

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Fluid transfer set, general-purpose

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Femoral canal sponge

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Accelerator system synchronizer

Manufacturer:

Anzai Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Dental suction system cannula, reusable

Manufacturer:

EURONDA S.P.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Haemodialysis needle

Manufacturer:

Bionic Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Airway pressure monitor, non-powered

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Oropharyngeal airway, single-use

Manufacturer:

Foremount Enterprise., Co. Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

System or Procedure Pack

Registration Date:

Sep 24, 2024

Bone matrix implant, synthetic, non-antimicrobial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Polyolefin/fluoropolymer suture, multifilament

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical depth gauge, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Tracheobronchial suction/insufflation catheter, single-lumen

Manufacturer:

NOVATECH SA

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Rigid optical bronchoscope

Manufacturer:

NOVATECH SA

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Pleural/peritoneal drainage catheterization kit

Manufacturer:

Primed Halberstadt Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Wearable percutaneous catheter/tube holder

Manufacturer:

Iberhospitex, S.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Open-surgery dissector

Manufacturer:

Hurricane Medical

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Tracheostomy tube, non-reinforced, non-customized, reusable

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Tracheostomy tube decannulation cap

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Tracheostomy tube guide-catheter

Manufacturer:

Venner Medical (Singapore) Pte Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Polymer orthopaedic cement restrictor, non-bioabsorbable

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic cement, non-antimicrobial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical screwdriver, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical drill guide, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Non-constrained polyethylene acetabular liner

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Micropace Pty Ltd

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Hypoallergenic skin adhesive tape

Manufacturer:

BioDerm, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

CPAP/BPAP nasal mask, single-use

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic implant/instrument assembling device

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Direct ophthalmoscope

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Steam sterilizer

Manufacturer:

EURONDA S.P.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Endothermic cold therapy pack

Manufacturer:

EURONDA S.P.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Dental suction system cannula, single-use

Manufacturer:

EURONDA S.P.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Fixed-bearing total ankle prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical countersink, single-use

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Reinforced endotracheal tube, single-use

Manufacturer:

Venner Medical (Singapore) Pte Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

CPAP/BPAP face mask, single-use

Manufacturer:

Foremount Enterprise., Co. Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Non-rebreathing oxygen face mask

Manufacturer:

Foremount Enterprise., Co. Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Radiation therapy software

Manufacturer:

Radiological Imaging Technology, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical drill guide, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical implant/trial-implant/sizer holder, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical torque wrench, reusable

Manufacturer:

SERF

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Invasive vascular ultrasound system probe

Manufacturer:

Hadeco, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic cement, antimicrobial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic cement, non-antimicrobial

Manufacturer:

Tecres S.p.A.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

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

Manufacturer:

Venner Medical (Singapore) Pte Ltd.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Tracheostomy tube speech valve

Manufacturer:

Boston Medical Products, Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Manual intraocular lens injector, single-use

Manufacturer:

Hurricane Medical

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Image display unit, colour

Manufacturer:

MediCapture, Inc.

Type:

General Medical Device

Registration Date:

Sep 23, 2024

Infrared patient thermometer, skin

Manufacturer:

HuBDIC Co., Ltd

Type:

General Medical Device

Registration Date:

Sep 15, 2024

Nasal aspirator, manual

Manufacturer:

HuBDIC Co., Ltd

Type:

General Medical Device

Registration Date:

Sep 15, 2024

Radiation therapy software

Manufacturer:

Limbus AI Inc.

Type:

General Medical Device

Registration Date:

Sep 15, 2024

Body aspiration needle, single-use

Manufacturer:

TyTek Medical

Type:

General Medical Device

Registration Date:

Sep 1, 2024

Intraoperative gamma radiation detection system probe, reusable

Manufacturer:

GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A.

Type:

General Medical Device

Registration Date:

Sep 1, 2024

Dental composite resin

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Dental etching solution

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Dental composite resin kit

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Dentine bonding agent/set

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Temporary dental crown/bridge

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Orthodontic bracket adhesive

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Dental amalgam

Manufacturer:

DMP Dental Industry S.A.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Breast pump support kit, reusable

Manufacturer:

Bistos Co., Ltd.

Type:

General Medical Device

Registration Date:

Aug 25, 2024

Cardiopulmonary bypass system heating/cooling unit

Manufacturer:

Gentherm Medical LLC

Type:

General Medical Device

Registration Date:

Jul 31, 2024

Basic electric hospital bed

Manufacturer:

The Morel Company LLC

Type:

General Medical Device

Registration Date:

Jul 31, 2024

Circulating-fluid whole-body cooling system control unit

Manufacturer:

Gentherm Medical LLC

Type:

General Medical Device

Registration Date:

Jul 31, 2024

Non-adhesive device retention bandage

Manufacturer:

CMC Consumer Medical Care GmbH

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Dressing-fixation skin adhesive tape, non-silicone

Manufacturer:

CMC Consumer Medical Care GmbH

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Non-adhesive device retention bandage

Manufacturer:

CMC Consumer Medical Care GmbH

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Eye heat therapy pack, reusable

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Adhesive bandage

Manufacturer:

CMC Consumer Medical Care GmbH

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Cotton pleats

Manufacturer:

CMC Consumer Medical Care GmbH

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Non-woven gauze pad

Manufacturer:

CMC Consumer Medical Care GmbH

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Pressure bandage, non-latex, single-use

Manufacturer:

CMC Consumer Medical Care GmbH

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Pressure bandage, non-latex, single-use

Manufacturer:

CMC Consumer Medical Care GmbH

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Ocular hook/spatula/manipulator, single-use

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Intraocular pressure-reducing system

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Ophthalmic sponge

Manufacturer:

Katena Products, Inc.

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Dressing-fixation skin adhesive tape, non-silicone

Manufacturer:

CMC Consumer Medical Care GmbH

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Manufacturer:

CMC Consumer Medical Care GmbH

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Hypoallergenic skin adhesive tape

Manufacturer:

CMC Consumer Medical Care GmbH

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Skin-cover adhesive strip, non-antimicrobial

Manufacturer:

CMC Consumer Medical Care GmbH

Type:

General Medical Device

Registration Date:

Jul 29, 2024

Dental prosthesis veneer resin

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Jul 28, 2024

Dental polishing cup, single-use

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Jul 28, 2024

Blood transfusion filter

Manufacturer:

MACROPHARM SRL

Type:

General Medical Device

Registration Date:

Jul 8, 2024

General-body orifice lubricant

Manufacturer:

Wolfgang Meiners Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Jul 1, 2024

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Manufacturer:

Wolfgang Meiners Medizintechnik GmbH

Type:

General Medical Device

Registration Date:

Jul 1, 2024

Intermittent venous compression system

Manufacturer:

DAESUNG MAREF CO.,LTD.

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Bare-metal biliary stent

Manufacturer:

Mediwood Co., Ltd.

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Bare-metal colonic stent

Manufacturer:

Mediwood Co., Ltd.

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Circulating-fluid thermal therapy system control unit

Manufacturer:

DAESUNG MAREF CO.,LTD.

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Polymer-metal duodenal stent

Manufacturer:

Mediwood Co., Ltd.

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Bare-metal duodenal stent

Manufacturer:

Mediwood Co., Ltd.

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Bare-metal oesophageal stent

Manufacturer:

Mediwood Co., Ltd.

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Polymer-metal oesophageal stent

Manufacturer:

Mediwood Co., Ltd.

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Hand/wrist continuous passive motion exerciser

Manufacturer:

DAESUNG MAREF CO.,LTD.

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Surgical pneumatic tourniquet system

Manufacturer:

DAESUNG MAREF CO.,LTD.

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Polymer-metal biliary stent, non-bioabsorbable

Manufacturer:

Mediwood Co., Ltd.

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Polymer-metal colonic stent

Manufacturer:

Mediwood Co., Ltd.

Type:

General Medical Device

Registration Date:

Jun 24, 2024

Hospital stretcher, manual

Manufacturer:

GIVAS S.R.L

Type:

General Medical Device

Registration Date:

Jun 17, 2024

Neonatal bed

Manufacturer:

GIVAS S.R.L

Type:

General Medical Device

Registration Date:

Jun 17, 2024

Blood lancet, single-use

Manufacturer:

Phoenix Innovative Healthcare Manufacturers Pvt Ltd.

Type:

General Medical Device

Registration Date:

Jun 10, 2024

Endotracheal tube introducer, single-use

Manufacturer:

Venner Medical (Singapore) Pte Ltd.

Type:

General Medical Device

Registration Date:

Jun 10, 2024

Rigid intubation laryngoscope, reusable

Manufacturer:

Venner Medical (Singapore) Pte Ltd.

Type:

General Medical Device

Registration Date:

Jun 10, 2024

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

Manufacturer:

Venner Medical (Singapore) Pte Ltd.

Type:

General Medical Device

Registration Date:

Jun 10, 2024

Artificial airway stylet, reusable

Manufacturer:

Venner Medical (Singapore) Pte Ltd.

Type:

General Medical Device

Registration Date:

Jun 10, 2024

Laryngoscope blade, single-use

Manufacturer:

Venner Medical (Singapore) Pte Ltd.

Type:

General Medical Device

Registration Date:

Jun 10, 2024

Skin-cleaning wipe, sterile

Manufacturer:

Phoenix Innovative Healthcare Manufacturers Pvt Ltd.

Type:

General Medical Device

Registration Date:

Jun 10, 2024

Ophthalmic knife, single-use

Manufacturer:

SURGI LAB AG

Type:

General Medical Device

Registration Date:

Jun 3, 2024

Dental coating, tooth-desensitizing, professional

Manufacturer:

Beutlich Pharmaceuticals, LLC

Type:

General Medical Device

Registration Date:

May 24, 2024

Dental coating, tooth-desensitizing, home-use

Manufacturer:

Beutlich Pharmaceuticals, LLC

Type:

General Medical Device

Registration Date:

May 24, 2024

Haematological concentrate system preparation kit, platelet concentration

Manufacturer:

T-BİYOTEKNOLOJİ LABORATUVAR ESTETİK MEDİKAL KOZMETİK SAN. VE TİC. LTD. ŞTİ.

Type:

System or Procedure Pack

Registration Date:

Apr 11, 2024

Surgical/medical procedure irrigation fluid

Manufacturer:

VIOSER S.A. PARENTERAL SOLUTIONS INDUSTRY

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Infant/regional-body warmer

Manufacturer:

Weyer GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Ya Horng Electronic Co., Ltd

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Electrocardiograph, professional, single-channel

Manufacturer:

Ya Horng Electronic Co., Ltd

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Lift thread, bioabsorbable

Manufacturer:

Yurim Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Manufacturer:

Yurim Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Haematological concentrate system

Manufacturer:

T-BİYOTEKNOLOJİ LABORATUVAR ESTETİK MEDİKAL KOZMETİK SAN. VE TİC. LTD. ŞTİ.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Haematological concentrate system preparation kit, platelet concentration

Manufacturer:

T-BİYOTEKNOLOJİ LABORATUVAR ESTETİK MEDİKAL KOZMETİK SAN. VE TİC. LTD. ŞTİ.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Haematological concentrate system preparation kit, platelet concentration

Manufacturer:

T-BİYOTEKNOLOJİ LABORATUVAR ESTETİK MEDİKAL KOZMETİK SAN. VE TİC. LTD. ŞTİ.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Stromal vascular fraction recovery set

Manufacturer:

T-BİYOTEKNOLOJİ LABORATUVAR ESTETİK MEDİKAL KOZMETİK SAN. VE TİC. LTD. ŞTİ.

Type:

System or Procedure Pack

Registration Date:

Apr 11, 2024

Diagnostic spirometer, professional

Manufacturer:

Uscom Kft.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Noninvasive haemodynamic monitoring system

Manufacturer:

Uscom Limited

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Infant warmer

Manufacturer:

Weyer GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Eye irrigation kit

Manufacturer:

VIOSER S.A. PARENTERAL SOLUTIONS INDUSTRY

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Overhead infant phototherapy unit

Manufacturer:

Weyer GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Warming infant bed, adjustable

Manufacturer:

Weyer GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Warming infant bed, adjustable

Manufacturer:

Weyer GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Infrared patient thermometer, skin

Manufacturer:

Ya Horng Electronic Co., Ltd

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

YETI Dentalprodukte GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Suturing needle, single-use

Manufacturer:

Yurim Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Peritoneal drainage catheter

Manufacturer:

Bearpac Medical LLC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Thoracic suction pump

Manufacturer:

Bearpac Medical LLC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Haematological concentrate system

Manufacturer:

T-BİYOTEKNOLOJİ LABORATUVAR ESTETİK MEDİKAL KOZMETİK SAN. VE TİC. LTD. ŞTİ.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Haematological concentrate system

Manufacturer:

T-BİYOTEKNOLOJİ LABORATUVAR ESTETİK MEDİKAL KOZMETİK SAN. VE TİC. LTD. ŞTİ.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Haematological concentrate system

Manufacturer:

T-BİYOTEKNOLOJİ LABORATUVAR ESTETİK MEDİKAL KOZMETİK SAN. VE TİC. LTD. ŞTİ.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Haematological concentrate system preparation kit, platelet concentration

Manufacturer:

T-BİYOTEKNOLOJİ LABORATUVAR ESTETİK MEDİKAL KOZMETİK SAN. VE TİC. LTD. ŞTİ.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Subdermal needle electrode

Manufacturer:

The Electrode Store

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Infrared patient thermometer, skin

Manufacturer:

TECNIMED s.r.l.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Insect bite/sting electrical stimulator

Manufacturer:

TECNIMED s.r.l.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Electromyographic needle electrode, single-use

Manufacturer:

The Electrode Store

Type:

General Medical Device

Registration Date:

Apr 11, 2024

ENFit/ENFit linear connector

Manufacturer:

The Insides Company Limited

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Peripheral vascular intervention infusion catheter

Manufacturer:

Upstream Peripheral Technologies Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Automatic-inflation electronic sphygmomanometer, non-portable

Manufacturer:

Uscom Limited

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Vascular ultrasound system control unit

Manufacturer:

Vascular Technology, Incorporated

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Constrained polyethylene acetabular liner

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Pleural catheter

Manufacturer:

Bearpac Medical LLC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Pleural/peritoneal drainage catheterization kit

Manufacturer:

Bearpac Medical LLC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Autologous adipose tissue collection/washing set

Manufacturer:

T-BİYOTEKNOLOJİ LABORATUVAR ESTETİK MEDİKAL KOZMETİK SAN. VE TİC. LTD. ŞTİ.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Haematological concentrate system preparation kit, platelet concentration

Manufacturer:

T-BİYOTEKNOLOJİ LABORATUVAR ESTETİK MEDİKAL KOZMETİK SAN. VE TİC. LTD. ŞTİ.

Type:

System or Procedure Pack

Registration Date:

Apr 11, 2024

Corneal bur system, battery-powered

Manufacturer:

The Alger Company, Inc

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Diverting enterostomy re-feeding pump

Manufacturer:

The Insides Company Limited

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Invasive/noninvasive vascular ultrasound probe

Manufacturer:

Vascular Technology, Incorporated

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Ya Horng Electronic Co., Ltd

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Dental casting non-noble alloy

Manufacturer:

YETI Dentalprodukte GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Hypodermic needle, single-use

Manufacturer:

Yurim Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Alternating-pressure bed mattress overlay system

Manufacturer:

Micropace Pty Ltd

Type:

General Medical Device

Registration Date:

Feb 23, 2024

Mobile patient lifting system, electrically-powered

Manufacturer:

Apex Health Care Mfg.,Inc

Type:

General Medical Device

Registration Date:

Apr 25, 2023

Surgical instrument/endoscope cleaning utensil, single-use

Manufacturer:

PriMed Instruments Inc.

Type:

General Medical Device

Registration Date:

Apr 25, 2023

Autologous blood collection tube

Manufacturer:

STR BIYO TEKNOLOJILERI MEDIKAL IML.ITH. ve IHR.SAN.TIC.LTD.STI

Type:

General Medical Device

Registration Date:

Dec 16, 2022

Surgical saw blade, oscillating, single-use

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Bone-coring punch, reusable

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Orthopaedic bone wire

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Orthopaedic bone wire

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Orthopaedic bur, reusable

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Orthopaedic osteotome

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Surgical saw blade, oscillating, single-use

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Tibia nail

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Surgical screwdriver, reusable

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Surgical instrument/endoscope cleaning utensil, reusable

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Surgical drill guide, reusable

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Surgical depth gauge, reusable

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Orthopaedic trocar blade, reusable

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Orthopaedic fixation plate, non-bioabsorbable, sterile

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Orthopaedic bone staple, non-adjustable

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Orthopaedic bone staple, non-adjustable

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Humerus nail

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Hand-held surgical retractor, reusable

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Bone lever/elevator, reusable

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Chisel/osteotome blade handle

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Colonic lavage kit, surgical

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Device sterilization/disinfection container, reusable

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Tibia nail

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Surgical drill guide, single-use

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Orthopaedic implant reamer

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Orthopaedic chisel blade

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Externally-mounted endoscopic tissue manipulation forceps

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Orthopaedic bur, single-use

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Humerus nail

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Femur nail

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Femur nail

Manufacturer:

mahe medical GmbH

Type:

General Medical Device

Registration Date:

Dec 12, 2022

Neurosurgical procedure kit, non-medicated, single-use

Manufacturer:

NICO Corporation

Type:

System or Procedure Pack

Registration Date:

Oct 27, 2022

General utility supply system, wall-mounted

Manufacturer:

Vision Technology Systems GmbH

Type:

General Medical Device

Registration Date:

Sep 9, 2022

Gastrointestinal motility manometric catheter, non-electronic

Manufacturer:

H&A Mui Enterprises Inc (Mui Scientific)

Type:

General Medical Device

Registration Date:

Sep 8, 2022

Gastrointestinal barostat

Manufacturer:

H&A Mui Enterprises Inc (Mui Scientific)

Type:

General Medical Device

Registration Date:

Sep 8, 2022

Gastrointestinal motility manometric catheter, non-electronic

Manufacturer:

H&A Mui Enterprises Inc (Mui Scientific)

Type:

General Medical Device

Registration Date:

Sep 8, 2022

Rigid nasopharyngoscope

Manufacturer:

H&A Mui Enterprises Inc (Mui Scientific)

Type:

General Medical Device

Registration Date:

Sep 8, 2022

Flexible video nasopharyngoscope

Manufacturer:

H&A Mui Enterprises Inc (Mui Scientific)

Type:

General Medical Device

Registration Date:

Sep 8, 2022

Manometric gastrointestinal motility analysis system

Manufacturer:

H&A Mui Enterprises Inc (Mui Scientific)

Type:

General Medical Device

Registration Date:

Sep 8, 2022

Endoscopic overtube, single-use

Manufacturer:

H&A Mui Enterprises Inc (Mui Scientific)

Type:

General Medical Device

Registration Date:

Sep 8, 2022

CAD/CAM software

Manufacturer:

Prismatik Dentalcraft. Inc

Type:

General Medical Device

Registration Date:

Aug 18, 2022

Antimicrobial susceptibility analyser IVD

Manufacturer:

Quantamatrix Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 26, 2022

Acupuncture needle, single-use

Manufacturer:

NEO Dr. INC.

Type:

General Medical Device

Registration Date:

Mar 16, 2022

Aneroid manual sphygmomanometer

Manufacturer:

LUXAMED GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Mar 9, 2022

Tongue depressor, surgical

Manufacturer:

Throat Scope Pty Ltd

Type:

General Medical Device

Registration Date:

Feb 24, 2022

Surgical apron, single-use

Manufacturer:

Bayteks Teknik Tekstil Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Dec 14, 2021

Patient surgical drape, single-use

Manufacturer:

Bayteks Teknik Tekstil Sanayi ve Ticaret Anonim Şirketi

Type:

General Medical Device

Registration Date:

Dec 14, 2021

Basic electric hospital bed

Manufacturer:

CARETEK (CHINA) MEDICAL PLC

Type:

General Medical Device

Registration Date:

Dec 10, 2021

Laser patient positioning system

Manufacturer:

Neorad B.V.

Type:

General Medical Device

Registration Date:

Dec 10, 2021

Pressure algometer, electronic

Manufacturer:

JTECH Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Dec 9, 2021

Medical networking interface unit

Manufacturer:

JTECH Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Dec 9, 2021

Hand dynamometer/pinchmeter, electronic

Manufacturer:

JTECH Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Dec 9, 2021

Joint/spinal manipulator, mechanical

Manufacturer:

JTECH Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Dec 9, 2021

Biomechanical function analysis/rehabilitation software

Manufacturer:

JTECH Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Dec 9, 2021

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

Manufacturer:

Datar Cancer Genetics Pvt. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 9, 2021

Cancer marker/gene/chemosensitivity profile kit IVD

Manufacturer:

Datar Cancer Genetics Pvt. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 9, 2021

Electronic goniometer/kinesiology sensor

Manufacturer:

JTECH Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Dec 9, 2021

Circulating tumour DNA/RNA IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Datar Cancer Genetics Pvt. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 9, 2021

Cancer cell chemosensitivity assay kit IVD

Manufacturer:

Datar Cancer Genetics Pvt. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 9, 2021

Dynamometer force gauge

Manufacturer:

JTECH Medical Industries, Inc.

Type:

General Medical Device

Registration Date:

Dec 9, 2021

Multiple solid tumour differentiation marker IVD, kit, fluorescent immunoassay

Manufacturer:

Datar Cancer Genetics Pvt. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 9, 2021

Pelvic floor muscle exerciser

Manufacturer:

RR Medical s.r.o.

Type:

General Medical Device

Registration Date:

Dec 6, 2021

General utility supply system, ceiling-mounted

Manufacturer:

Peratek Teknik Tibbi Sistemler San. ve Tic. A.S

Type:

General Medical Device

Registration Date:

Nov 22, 2021

Kinesiology/electromyographic sensor set

Manufacturer:

Noraxon USA, Inc.

Type:

General Medical Device

Registration Date:

Nov 17, 2021

Biofeedback system application software

Manufacturer:

Noraxon USA, Inc.

Type:

General Medical Device

Registration Date:

Nov 17, 2021

Oral/enteral medicine medicated administration kit, single-use

Manufacturer:

elm-plastic GmbH

Type:

General Medical Device

Registration Date:

Oct 6, 2021

Autologous adipose tissue collection/washing set

Manufacturer:

MEIKA GROUP S.r.l

Type:

General Medical Device

Registration Date:

Oct 1, 2021

Nasopharyngeal airway, single-use

Manufacturer:

Foremount Enterprise., Co. Ltd.

Type:

General Medical Device

Registration Date:

Sep 7, 2021

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

Manufacturer:

Trentron Biomedical Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 31, 2021

Skin biopsy blade

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Dermal curette

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Suture cutter, single-use

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Scalpel, single-use

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Manual scalpel blade, single-use

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Scalpel handle, reusable

Manufacturer:

RAZORMED INC.

Type:

General Medical Device

Registration Date:

Aug 31, 2021

Hollow-fibre haemodialysis dialyser, single-use

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Aug 25, 2021

Haemodialysis system dialysate pyrogen filter

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Aug 25, 2021

Haemodialysis needle

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Aug 25, 2021

Sodium carbonate haemodialysis system cleaning cartridge

Manufacturer:

Allmed Medical GmbH

Type:

General Medical Device

Registration Date:

Aug 25, 2021

Ultraviolet phototherapy unit, home-use

Manufacturer:

Dermfix Limited

Type:

General Medical Device

Registration Date:

Aug 19, 2021

Posturography system

Manufacturer:

SYNAPSYS Sas

Type:

General Medical Device

Registration Date:

Aug 17, 2021

Dynamic visual acuity testing system

Manufacturer:

SYNAPSYS Sas

Type:

General Medical Device

Registration Date:

Aug 17, 2021

Dynamic visual acuity testing system

Manufacturer:

SYNAPSYS Sas

Type:

General Medical Device

Registration Date:

Aug 17, 2021

Posturography system

Manufacturer:

SYNAPSYS Sas

Type:

General Medical Device

Registration Date:

Aug 17, 2021

Carbon dioxide monitor

Manufacturer:

Newtech, Inc.

Type:

General Medical Device

Registration Date:

Aug 12, 2021

Pulse oximeter

Manufacturer:

Newtech, Inc.

Type:

General Medical Device

Registration Date:

Aug 12, 2021

Pulmonary resuscitator, manual, single-use

Manufacturer:

Mercury Medical

Type:

General Medical Device

Registration Date:

Aug 10, 2021

Suturing needle holder, single-use

Manufacturer:

FlexDex Inc.

Type:

General Medical Device

Registration Date:

Jun 24, 2021

Gastrointestinal gas suppressant

Manufacturer:

Medical Brands Developments BV

Type:

General Medical Device

Registration Date:

Jun 10, 2021

Extramuscular diaphragm/phrenic nerve electrical stimulation system

Manufacturer:

Atrotech Oy

Type:

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

Registration Date:

May 19, 2021

Transcutaneous electrical stimulation electrode, single-use

Manufacturer:

Ampcare, LLC

Type:

General Medical Device

Registration Date:

May 14, 2021

Transcutaneous electrical stimulation lead

Manufacturer:

Ampcare, LLC

Type:

General Medical Device

Registration Date:

May 14, 2021

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

Ampcare, LLC

Type:

General Medical Device

Registration Date:

May 14, 2021

Cervicothoracic spine orthosis

Manufacturer:

Ampcare, LLC

Type:

General Medical Device

Registration Date:

May 14, 2021

Lumbar total intervertebral disc prosthesis

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Apr 30, 2021

Basic diagnostic x-ray system application software

Manufacturer:

Zirkonzahn srl

Type:

General Medical Device

Registration Date:

Apr 30, 2021

Cervical total intervertebral disc prosthesis, modular

Manufacturer:

F.H INDUSTRIE

Type:

General Medical Device

Registration Date:

Apr 30, 2021

Orthopaedic cement, antimicrobial

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Apr 29, 2021

Bone matrix implant, synthetic, non-antimicrobial

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Apr 29, 2021

Aqueous/vitreous humour replacement medium kit

Manufacturer:

Bohus BioTech AB

Type:

General Medical Device

Registration Date:

Apr 29, 2021

Bone matrix implant, synthetic, non-antimicrobial

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Apr 29, 2021

Orthopaedic cement preparation/delivery kit

Manufacturer:

TEKNIMED SAS

Type:

General Medical Device

Registration Date:

Apr 29, 2021

Left-ventricular wireless pacing system transducer/electrode

Manufacturer:

EBR Systems, Inc.

Type:

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

Registration Date:

Apr 22, 2021

Ophthalmodiastimeter

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Apr 22, 2021

Extramuscular diaphragm/phrenic nerve electrical stimulation system

Manufacturer:

Avery Biomedical Devices (ABD) Inc.

Type:

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

Registration Date:

Apr 22, 2021

Posterior-chamber intraocular lens, pseudophakic

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Apr 22, 2021

Cardiac pulse generator programmer

Manufacturer:

EBR Systems, Inc.

Type:

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

Registration Date:

Apr 22, 2021

Left-ventricular wireless pacing system transducer/electrode

Manufacturer:

EBR Systems, Inc.

Type:

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

Registration Date:

Apr 22, 2021

Implantable pacemaker battery

Manufacturer:

EBR Systems, Inc.

Type:

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

Registration Date:

Apr 22, 2021

Retinal optical coherence tomography system

Manufacturer:

NIDEK CO., LTD.

Type:

General Medical Device

Registration Date:

Apr 22, 2021

Left-ventricular wireless pacing system sensor/transmitter

Manufacturer:

EBR Systems, Inc.

Type:

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

Registration Date:

Apr 22, 2021

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

Last updated: December 2025