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Search the Releasable 510(k) Database | FDA
https://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: Search...
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510(k) Premarket Notification - Food and Drug Administration
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
4 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...
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Medical Device Databases | FDA
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
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 ...
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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
Aug 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; Downloadable...
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510(K) Premarket Notification - Food and Drug Administration
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/TextResults.cfm
510 (K) Premarket Notification. APTUS ENDOSYSTEMS, INC. CONWAY STUART MEDICAL, INC. BIOLASE TECHNOLOGY, INC. ALLEGIANCE HEALTHCARE CORP. BARZELL-WHITMORE MAROON BELLS, INC. R-GROUP INTL. HOMEDICS, INC. * The maximum 500 records meeting your search criteria returned.
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510 (k) Clearances - Food and Drug Administration
https://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...
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Premarket Notifications (510(k)s) - Catalog
https://catalog.data.gov/dataset/premarket-notifications-510ks
Mar 16, 2021 · 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.
DA: 3 PA: 93 MOZ Rank: 66
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Premarket Notification 510(k) | FDA
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
Oct 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...
DA: 91 PA: 38 MOZ Rank: 92
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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
510 (k) "Substantial Equivalence" Decision Making Process (PDF - 844KB) Indications for Use (PDF - 1.7MB) Required Elements for a Declaration of Conformity to a Recognized Standard. Forms ...
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FDA 510(k) Explained: A Basic Guide to Premarket Notification
https://www.thefdagroup.com/blog/510k-explained
Mar 23, 2023 · Types of 510 (k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510 (k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510 (k)s in its Refuse to Accept Policy for 510 (k)s guidance document.
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