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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: 89 PA: 13 MOZ Rank: 33
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510(k) Premarket Notification - Food and Drug Administration
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
WebApr 15, 2024 · 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: 60 PA: 87 MOZ Rank: 43
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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) 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;...
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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 ...
DA: 10 PA: 82 MOZ Rank: 39
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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 that is not subject to premarket approval (PMA). 510 (k) (premarket notification) to FDA is required at least 90 days before marketing unless the device ...
DA: 25 PA: 16 MOZ Rank: 8
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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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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.
DA: 34 PA: 75 MOZ Rank: 96
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Premarket Approval (PMA) - Food and Drug Administration
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
WebApr 15, 2024 · Databases. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk ...
DA: 60 PA: 94 MOZ Rank: 74
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Everything you need to know about the FDA 510(k) submission
https://www.qualio.com/blog/fda-510k-submission
WebOct 13, 2023 · The FDA's 510(k) submission process is, in short, a quality and compliance barrier designed to only let safe, effective medical devices onto the U.S. market, and into contact with American patients. The focus of the 510(k) process is to prove something called 'substantial equivalence'.
DA: 61 PA: 13 MOZ Rank: 55