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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 Software as a...
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
Overview of Device Regulation | FDA
- https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
- Manufacturers must list their devices with the FDA. Establishments required to list their devices include: manufacturers, contract manufacturers, contract sterilizers, …
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 …
Importing Medical Devices | FDA
- https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices
- The FDA defines a medical device as: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a …
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
- Device Use GE Nuclear Medicine 600 and 800 Series systems are used by health care professionals to evaluate diseases, trauma, abnormalities, and disorders. …
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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