Fda 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

Search the Releasable 510 (k) Database You can search the releasable 510 (k) database by Panel, 510 (k) number, Product code or Device name. A search query will produce …

Medical Device Databases | FDA

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

Apr 6, 2022

510(k) Devices Cleared in 2022 | FDA - U.S. Food and …

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

510 (k) Devices Cleared in 2022 | FDA Home Medical Devices Products and Medical Procedures Device Approvals, Denials and Clearances 510 (k) Clearances 510 (k) …

Premarket Notification 510(k) | FDA

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

The FD&C Act and the 510 (k) regulation (21 CFR 807) do not specify who must submit a 510 (k). Instead, they specify which actions, such as introducing a device …

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

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

The 510 (k) should provide sufficient detail for FDA to be able to determine that the device is substantially equivalent (SE) to another similar legally marketed device (s). Some sections...

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

A device may be exempt from 510 (k) requirements if the FDA determines that a 510 (k) is not required to provide reasonable assurance of safety and effectiveness …

How to Find and Effectively Use Predicate Devices | FDA

https://www.fda.gov/medical-devices/premarket-notification-510k/how-find-and-effectively-use-predicate-devices

The FDA 510 (k) database contains all devices cleared under the 510 (k) process. The FDA databases on the web are updated on or around the 5th of every month. The …

Establishment Registration & Device Listing - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm

This database includes: medical device manufacturers registered with FDA and medical devices listed with FDA Note: Registration of a device establishment, …

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