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Devices@FDA is a catalog of cleared and approved medical device information from FDA. It includes links to the device summary information, manufacturer, approval date, user instructions, and...
Search the Registration & Listing database. Establishment Registration and Medical Device Listing Files for Download. Releasable establishment registration and listing information under the...
This database includes: medical device manufacturers registered with FDA and; medical devices listed with FDA; Note: Registration of a device establishment, assignment of a registration number,...
The FDA maintains several publicly accessible databases that may be of particular interest to sponsors and manufacturers of neurological devices.
Search the 510(k) Database; Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval...
FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products.
Devices@FDA is a catalog of cleared and approved medical device information from fda. it includes links to the device summary information, manufacturer, approval date, user instructions, and...
Enter a search term below and select Search: MDR Search Values. Product Description. Manufacturer. Product Code 25. Report Type. Death Injury Malfunction. Date Report Received by FDA (mm/dd/yyyy)
Medical Device Recalls. This database contains Medical Device Recalls classified since November 2002. Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the FDA. The status is updated if the FDA identifies a violation and classifies the action as a recall and again when the recall is ...
The FDA is establishing the unique device identification system to adequately identify devices sold in the U.S.- from manufacturing through distribution to patient use. You can use AccessGUDID to search for specific medical devices or download all the GUDID data at once.