Medical Device Fda Database

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Medical Device Databases | FDA

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

Apr 6, 2022

Establishment Registration & Device Listing - Food and …

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

Search Registration and Listing | FDA

https://www.fda.gov/medical-devices/device-registration-and-listing/search-registration-and-listing

Search the Registration & Listing database ; Establishment Registration and Medical Device Listing Files for Download ; Releasable establishment registration and listing …

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. ... Search Medical Device Databases. 510(k) Premarket …

MAUDE - Manufacturer and User Facility Device …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters …

Search Databases | FDA - U.S. Food and Drug …

https://www.fda.gov/industry/fda-basics-industry/search-databases

When a medical device violates FDA law, FDA can take action to enforce compliance and ensure public health. ... This page includes a list of databases relevant …

510(k) Premarket Notification - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

510 (k) Premarket Notification. 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 …

Product Code Classification Database | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database

This database contains device names and their associated product codes. The name and product code identify the generic category of a device for FDA. The Product Code …

Medical Device Databases and Resources | FDA

https://www.fda.gov/medical-devices/neurological-devices/medical-device-databases-and-resources

Medical Device Databases and Resources. The FDA maintains several publicly accessible databases that may be of particular interest to sponsors and manufacturers of …

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