Official database · FDAFDA 510(k) medical device database
Search official FDA application numbers, device names, applicants, product codes and historical decisions. Includes K and DEN entries published in the openFDA 510(k) export.
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176,366 records34,677 applicantssource FDAlast checked Oct 14, 2026
About the data
Where these records come from
This database mirrors the complete official openFDA 510(k) bulk export, including the DEN entries FDA publishes in that export. It is checked daily; the official export is refreshed periodically. Historical decisions do not establish current marketing status. This collection excludes PMA and is not a complete register of every device sold in the United States.
VerifiedFDA · last checked Oct 14, 2026
- What does an entry establish?
- It preserves the application and decision published by FDA. A 510(k) clearance is a substantial-equivalence decision; it is not PMA approval or proof that a device is currently marketed.
- What does the product-code class mean?
- The harmonized class refers to the current product-code classification. It is kept separate from the original application and does not identify the applicant’s manufacturing establishments.
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