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Search the Releasable 510(k) Database | FDA
https://www.fda.gov/medical-devices/510k-clearances/search-releasable-510k-database
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: 58 PA: 63 MOZ Rank: 4
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510(k) Premarket Notification - Food and Drug Administration
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
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: 99 PA: 27 MOZ Rank: 47
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Medical Device Databases | FDA
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
WebThis database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code.
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510(k) Clearances | FDA - U.S. Food and Drug Administration
https://www.fda.gov/medical-devices/device-approvals-and-clearances/510k-clearances
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...
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510(K) Premarket Notification - Food and Drug Administration
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/TextResults.cfm
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 ...
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510(k) Submission Process | FDA
https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process
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 ...
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510 (k) Clearances - Food and Drug Administration
https://open.fda.gov/data/510k/
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...
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Device 510(k) Overview - Food and Drug Administration
https://open.fda.gov/apis/device/510k/
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.
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510(k) Forms | FDA - U.S. Food and Drug Administration
https://www.fda.gov/medical-devices/premarket-notification-510k/510k-forms
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)
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510(k) Clearances | FDA - U.S. Food and Drug Administration
https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances
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: 48 PA: 50 MOZ Rank: 87