Fda Medical Device Alerts

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

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

The FDA monitors reports of adverse events and other problems with medical devices and ...

Medical Product Safety Information | FDA

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

MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The …

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

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

FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes CDRH recently issued two warning letters to a leading manufacturer of endoscopes, Olympus Medical …

MAUDE - Manufacturer and User Facility Device …

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

Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses …

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

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

Import alerts inform the FDA's field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that …

Medical Device Databases | FDA

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

Apr 6, 2022

Drug Alerts and Statements | FDA

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

7/2/2021 FDA alerts health care professionals and patients to a voluntary recall of varenicline (Chantix) to the warehouse level 5/19/21: FDA receives HHS grant to …

Establishment Registration & Device Listing - Food and …

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

medical device manufacturers registered with FDA and medical devices listed with FDA Note: Registration of a device establishment, assignment of a registration …

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