Medical Devices Gov

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 …

Device Registration and Listing | FDA

https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

For assistance with registration and listing status, please contact the CDRH Registration and Listing Help Desk at: Phone: 301-796-7400. Email: …

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

Search Registration and Listing | FDA

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

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Importing Medical Devices | FDA

https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices

Medical device classification, pre-market submission, medical device registration and listing, 510(k), PMA, medical device labeling ... [email protected]. Information-Medical …

GE HealthCare Recalls Nuclear Medicine Systems for …

https://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-nuclear-medicine-600800-series-systems-risk-detector-fall-may-injure-patients

See Medical Device Recall Database entry for more information. Distribution Dates: April 1, 2018 to December 16, 2022; Devices Recalled in the U.S.: 688; Date …

AccessGUDID - Identify Your Medical Device

https://accessgudid.nlm.nih.gov/

The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have …

Coronavirus (COVID-19) and Medical Devices | FDA

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/coronavirus-covid-19-and-medical-devices

Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public …