Fda Medical Device Alert

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Medical Device Safety | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/medical-device-safety

Medical Device Safety. The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when …

Medical Product Safety Information | FDA

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/medical-product-safety-information

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

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

CDRH 2022 Annual Report. Accomplishments for 2022, including the Pandemic Response, MDUFA V, Device Innovation, over-the-counter (OTC) hearing aid final rule, and device …

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 …

Drug Alerts and Statements | FDA

https://www.fda.gov/drugs/drug-safety-and-availability/drug-alerts-and-statements

3/24/2020 FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration. 10/11/2019 FDA …

Import Alerts | FDA - U.S. Food and Drug Administration

https://www.fda.gov/industry/actions-enforcement/import-alerts

This is the number issued by the FDA. The first 2 numbers are the industry code of the product. For example, any import alert that starts with a 16 will be related to seafood. …

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 …

Medical Device Recalls - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm

Medical Device Recalls. This database contains Medical Device Recalls classified since November 2002. Since January 2017, it may also include correction or …

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