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2. Search the Releasable 510(k) Database | FDA - U.S. Food and Drug...

   www.fda.gov/medical-devices/510k-clearances/search-releasable-510k-database

   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:

3. 510(k) Premarket Notification - Food and Drug Administration

   www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

   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 (section...

4. Medical Device Databases | FDA

   www.fda.gov/.../medical-device-databases

   This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code.

5. 510(k) Clearances | FDA - U.S. Food and Drug Administration

   www.fda.gov/medical-devices/device-approvals-and-clearances/510k-clearances

   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...

6. 510(K) Premarket Notification - Food and Drug Administration

   www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/TextResults.cfm

   04/04/2000. stela ut46 and bt45/46 straight tined pacing leads, stela uj45 and bj44/45 j-shaped tined pacing leads. ELA MEDICAL, INC. k000029. 04/04/2000. sonoace 600 diagnostic ultrasound system. MEDISON AMERICA, INC. k000030. 01/19/2000.

7. 510 (k) Clearances - Food and Drug Administration

   open.fda.gov/data/510k

   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 that...

8. Downloadable 510 (k) Files | FDA

   www.fda.gov/medical-devices/510k-clearances/downloadable-510k-files

   You can download any of the following zipped files, each of which contains information about the releasable 510(k)s for the time frame indicated. Each record in the file is 272 characters in...

9. Premarket Notifications (510 (k)s) - Catalog

   catalog.data.gov/dataset/premarket-notifications-510ks

   This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code. Summaries of safety and effectiveness information is available via the web interface for more recent records.

10. FDA 510(k) Applications Database

    510ks.warrick.net

    This website contains over 132,000 FDA 510(k) applications and decisions collected since May, 1976 from the U.S. Food and Drug Administration's publicly available databases of FDA Device Approvals and Clearances.

11. 510(k) Premarket Notification - Food and Drug Administration

    www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233358

    Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings 22. 510 (k) Number. K233358. Device Name. SCoV-2 Ag Detect Rapid Test. Applicant. InBios International, Inc. 307 Westlake Ave N, Suite 300.