Fda.Gov Medical Devices

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

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

Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in …

Coronavirus (COVID-19) and Medical Devices | FDA

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

Medical devices used to diagnose or treat COVID-19 include diagnostic tests, masks, gowns, gloves, sterilizers, and ventilators. Coronavirus (COVID-19) and Medical Devices …

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Classify Your Medical Device | FDA Classify Your Medical Device The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different …

At-Home OTC COVID-19 Diagnostic Tests | FDA

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests

Medical Devices Coronavirus (COVID-19) and Medical Devices Counterfeit At-Home OTC COVID-19 Diagnostic Tests At-Home COVID-19 Diagnostic Tests: …

Augmented Reality and Virtual Reality in Medical …

https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices

List of Medical Devices that Incorporate Augmented Reality and Virtual Reality The FDA has reviewed and authorized for marketing a growing number of …

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

GE Nuclear Medicine 600 and 800 Series systems are used by health care professionals to evaluate diseases, trauma, abnormalities, and disorders. These systems …

Establishment Registration & Device Listing - Food and …

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

Medical Devices Databases This database includes: medical device manufacturers registered with FDA and medical devices listed with FDA Note: …

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