• 1. Search the Releasable 510(k) Database | FDA

  fda.gov

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

  Description: WebYou 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:...

  DA: 98 PA: 55 MOZ Rank: 49

• 2. 510(k) Premarket Notification - Food and Drug Administration

  fda.gov

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

  Description: Web3 days ago · FDA Home. Medical Devices. Databases. 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...

  DA: 97 PA: 60 MOZ Rank: 32

• 3. Medical Device Databases | FDA

  fda.gov

  Link: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

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

  DA: 19 PA: 59 MOZ Rank: 23

• 4. 510(k) Clearances | FDA - U.S. Food and Drug Administration

  fda.gov

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

  Description: WebNov 6, 2023 · Browse and Search for 510(k) Clearances. Search the 510(k) Premarket Notification database. Browse for Clearances by Year. 510(k) Devices Cleared in 2023; 510(k) Devices Cleared...

  DA: 43 PA: 84 MOZ Rank: 21

• 5. 510(K) Premarket Notification - Food and Drug Administration

  fda.gov

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

  Description: Web510(K) Number. Decision Date. sem scanner (model 200) Bruin Biometrics, LLC den170021: 12/20/2018: single size tendon spacer: MEDIST INTERNATIONAL k000019: 03/29/2000: next step powder free latex examination gloves contains 50 mcgm or less of total water extractable protein per gram: ANSELL PERRY ...

  DA: 45 PA: 89 MOZ Rank: 13

• 6. 510(k) Submission Process | FDA

  fda.gov

  Link: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process

  Description: WebOct 3, 2022 · 510 (k) Submission Process. Send Medical Device eSTAR and eCopy Premarket Submissions Online. October 3, 2022 - The FDA is announcing that you may now send electronic copy (eCopy) or electronic ...

  DA: 53 PA: 3 MOZ Rank: 68

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

  fda.gov

  Link: https://open.fda.gov/data/510k/

  Description: WebA 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...

  DA: 67 PA: 94 MOZ Rank: 44

• 8. Device 510(k) Overview - Food and Drug Administration

  fda.gov

  Link: https://open.fda.gov/apis/device/510k/

  Description: WebThe openFDA Device 510(k) Clearances API contains details about specific products and the original sponsors of premarket notification applications. It also contains administrative and tracking information about the applications and receipt and decision dates.

  DA: 44 PA: 81 MOZ Rank: 99

• 9. 510(k) Forms | FDA - U.S. Food and Drug Administration

  fda.gov

  Link: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-forms

  Description: Web510(k) Submission Process; 510(k) Forms; 510(k) Submission Programs; How To Prepare A Special 510(k) How to Find and Effectively Use Predicate Devices; How to Prepare a Traditional 510(k)

  DA: 67 PA: 63 MOZ Rank: 7

• 10. 510(k) Clearances | FDA - U.S. Food and Drug Administration

  fda.gov

  Link: https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances

  Description: WebAug 31, 2021 · Search the Releasable 510(k) Database; 510(k) Devices Cleared in 2023; 510(k) Devices Cleared in 2022; 510(k) Devices Cleared in 2021; 510(k) Devices Cleared in 2020;...

  DA: 36 PA: 30 MOZ Rank: 58