Medical Device 510 K Database

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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 …

Medical Device Databases | FDA

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

Apr 6, 2022

Downloadable 510(k) Files | FDA

https://www.fda.gov/medical-devices/510k-clearances/downloadable-510k-files

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 …

Premarket Notification 510(k) | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k

A list of the Class I and II exempted devices can be found on Medical Device Exemptions 510(k) and GMP Requirements. However, if the device exceeds the …

Content of a 510(k) | FDA - U.S. Food and Drug …

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

It is clearly identified as "510 (k) Summary" as required by section 807.92 (c). [ ] The summary contains on the first page, preferably on your letterhead paper, the 510 (k) …

510(k) Devices Cleared in 2022 | FDA

https://www.fda.gov/medical-devices/510k-clearances/510k-devices-cleared-2022

This page lists all medical devices cleared through the CDRH Premarket Notification process [510 (K)] in 2022. January 2022 510 (K) Clearances. February 2022 510 (K) …

Product Classification - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

This database includes: ... Other Databases. 510(k)s; De Novo; Medical Device Reports (MAUDE) CDRH Export Certificate Validation (CECV) CDRH FOIA …

Class I and Class II Device Exemptions | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions

Most class I and some class II devices are exempt from 510 (k) requirements, subject to certain limitations (see section 510 (l) (1) of the Federal Food, …

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