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BME2000: Biomedical Engineering in the Clinical Environment

Searching for Medical Devices

Search a variety of databases at to gather medical device information:

  • Establishment Registration & Device Listing: includes medical device manufacturers registered with the FDA and medical devices listed with the FDA
    • Search with trade name or Owner Name
  • 510(k) Premarket Notification: includes devices that were introduced to commercial distribution for the first time and legally marketed devices that were changed or modified significantly that could affect its safety or effectiveness.
    • Search with device name
  • Devices@FDA: includes cleared and approved medical device information from the FDA. It simultaneously searches PMN-510(k) and PMA-Premarket Approval. Info includes: device summary information, manufacturer, approval date, user instructions, and other consumer information.
    • Search by device category, name, or manufacturer/company

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