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:42PA:96MOZ Rank:4
510(k) Premarket Notification - Food and Drug Administration
WEB4 days ago · 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 equivalent, to a...
WEBOct 3, 2022 · 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... database
database
DA:5PA:94MOZ Rank:72
510(k) Clearances | FDA - U.S. Food and Drug Administration
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:75PA:96MOZ Rank:81
510(K) Premarket Notification - Food and Drug Administration
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 ... database
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... database
database
DA:45PA:15MOZ Rank:64
Device 510(k) Overview - Food and Drug Administration
WEBKey Facts. Source of the data: 510 (k) Clearances. Changes to the source data: openFDA annotates the original records with special fields and converts the data into JSON, which is a widely used... database
database
DA:36PA:89MOZ Rank:15
510(k) Clearances | FDA - U.S. Food and Drug Administration
WEBMar 23, 2023 · The 510 (k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S.
WEBPremarket Notification 510 (k) searchable database. CFR search engine. The complete FDA Premarket Notification database is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use. Updates and changes. Pre-Stata13 had a string length limit of 244 characters.