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1. www.fda.gov › medical-devices › 510k-clearancesSearch the Releasable 510(k) Database | FDA - U.S. Food and Drug...

   www.fda.gov › medical-devices › 510k-clearances

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   You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following format:

   • Downloadable 510

     Search the Releasable 510(k) Database Downloadable 510(k)...

   • Premarket Notification

     A 510 (K) is a premarket submission made to FDA to...

   • Medical Device Databases

     CDRH Databases: a listing of databases for such topics as...

   • 510(K) Premarket Notification

     Note: If you need help accessing information in different...

2. www.accessdata.fda.gov › scripts › cdrh510(k) Premarket Notification - Food and Drug Administration

   www.accessdata.fda.gov › scripts › cdrh

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   5 dni temu · A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device...

3. www.fda.gov › medical-device-databasesMedical Device Databases | FDA

   www.fda.gov › medical-device-databases

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   CDRH Databases: a listing of databases for such topics as advisory committees, regulations, good practices, medical devices, Premarket Approval (PMA) and Notification (510 (k)), product codes ...

4. www.fda.gov › medical-devices › device-approvals-and-clearances510(k) Clearances | FDA - U.S. Food and Drug Administration

   www.fda.gov › medical-devices › device-approvals-and-clearances

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   Search the 510(k) Premarket Notification database. You can also download zipped 510(k) files for specific time periods. General Information. Medical Device Safety and the 510(k) Clearance...

5. www.accessdata.fda.gov › scripts › cdrh510(K) Premarket Notification - Food and Drug Administration

   www.accessdata.fda.gov › scripts › cdrh

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   Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

6. open.fda.gov › data › 510k510 (k) Clearances - Food and Drug Administration

   open.fda.gov › data › 510k

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   A 510 (k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device...

7. blog.bioaccessla.com › exploring-the-searchable-510-k-database-for-medical-devicesExploring the Searchable 510(k) Database for Medical Devices

   blog.bioaccessla.com › exploring-the-searchable-510-k-database-for-medical-devices

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   5 dni temu · The FDA's 510 (k) Database is an essential tool for accessing records of medical products that have received marketing clearance. According to section 510 (k) of the Federal Food, Drug, and Cosmetic Act, manufacturers must submit a premarket notification to the FDA to show that their product is substantially equivalent to a legally marketed Item.