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Are There "FDA Registered" or "FDA Certified" Medical …

    https://www.fda.gov/medical-devices/consumers-medical-devices/are-there-fda-registered-or-fda-certified-medical-devices-how-do-i-know-what-fda-approved

    Device Approvals, Denials and Clearances | FDA

      https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-denials-and-clearances
      A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient...

    Recently-Approved Devices | FDA - U.S. Food and Drug …

      https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/recently-approved-devices
      Humanitarian Device Exemptions (HDE): Listing of devices that have been approved to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the …

    2020 Device Approvals | FDA - U.S. Food and Drug …

      https://www.fda.gov/medical-devices/recently-approved-devices/2020-device-approvals
      Jan 14, 2022



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