fda approved medical devices database - Search
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  2. The FDA provides several databases related to approved medical devices:
    1. Medical Device Product Classification database: Lists over 6,000 types of medical devices regulated by FDA1.
    2. Voluntary consensus standards database: Provides the most up-to-date list of standards for which FDA will accept a Declaration of Conformity for medical devices2.
    3. ScanMedicine: A comprehensive database of clinical trials and FDA-approved medical devices, diagnostics, and digital applications3.
    4. CDRH searchable databases: Contain information on 510(k) and PMA approvals4.
    Learn more:
    Our Medical Device Product Classification database lists over 6,000 types of medical devices regulated by FDA's Center for Medical Devices and Radiological Health (CDRH) and the classification assigned to each type.

    Products and Medical Procedures | FDA

    www.fda.gov/medical-devices/products-and-medic…
    This database provides the most up-to-date list of voluntary consensus standards to which FDA will accept a Declaration of Conformity for medical devices.

    Recognized Consensus Standards: Med…

    www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStan…
    ScanMedicine is a comprehensive database of clinical trials and FDA-approved medical devices, diagnostics and digital applications developed by the National Institute for Health Research’s Innovation Observatory (NIHRIO), based at Newcastle University.

    ScanMedicine (NIHRIO) Searching Glob…

    scanmedicine.com/
    Searchable databases of devices previously approved for marketing or declared substantially equivalent to a legally marketed device. Databases CDRH maintains searchable databases on its website containing 510 (k) and PMA information

    Device Approvals and Clearances | FDA

    www.fda.gov/medical-devices/products-and-medic…
     
  3. Food and Drug Administration (.gov)
    https://www.fda.gov › ... › medical-device-databases

    Medical Device Databases | FDA - U.S. Food and Drug …

    • Registration & Listing

      Registration & Listing - Medical Device Databases | FDA - U.S. Food and Drug …

    • Product Classification

      This database includes: a list of all medical devices with their associated …

    • MDR Database Search

      10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA …

    • Devices@FDA

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

    • PMA

      Premarket approval (PMA) is the FDA process of scientific and regulatory …

    • Recognized Consensus S…

      This database provides the most up-to-date list of voluntary consensus standards to …

    • CLIA Currently Waived An…

      CLIA Currently Waived Analytes - Medical Device Databases | FDA - U.S. Food …

    • CFR

      FDA Home; Medical Devices; Databases - The information on this page is current …

    • 522 Postmarket Surveillan…

      The FDA has the authority to require device manufacturers to perform postmarket …

    • Maude

      The Manufacturer and User Facility Device Experience (MAUDE) database is a …

     
  4. Food and Drug Administration (.gov)
    https://www.fda.gov › medical-devices › products-and...

    Device Approvals and Clearances | FDA

  6. fda.gov
    https://www.accessdata.fda.gov › SCRIPTS › cdrh › device...

    Devices@FDA - Food and Drug Administration

    Tags:
    Medical device
    Food and Drug Administration
    FDA Device Approval
  7. fda.gov
    https://www.accessdata.fda.gov › scripts › cdrh › cfdocs › ...

    Establishment Registration & Device Listing - Food and Drug …

    Tags:
    FDA and Medical Devices
    Food and Drug Administration
  8. Food and Drug Administration (.gov)
    https://www.fda.gov › medical-devices › device...

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

  9. fda.gov
    https://www.accessdata.fda.gov › scripts › cdrh › cfdocs › ...

    Premarket Approval (PMA) - Food and Drug Administration

    Tags:
    FDA and Medical Devices
    Food and Drug Administration
  10. People also ask
    What is FDA Premarket Approval?
    Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device.

    Medical Device Databases | FDA

    fda.gov
    Where can I find information about medical device approvals?
    Welcome to FDA's information about medical device approvals. The following information is available: Recently Approved Devices that include some of the newest medical technology available. Searchable databases of devices previously approved for marketing or declared substantially equivalent to a legally marketed device.

    Device Approvals and Clearances | FDA

    fda.gov
    What information is included in a medical device database?
    This database includes: a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information. Learn More... Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

    Product Classification - Food and Drug Administration

    accessdata.fda.gov
    What is FDA approval date?
    Decision Date: Date of approval on record with the FDA. May be referred to as Approval Date in select databases. Contact: This information may be recorded as the Applicant, Correspondent, Owner/Operator, or Manufacturer on file with the FDA. Class: Medical device classification assigned by the FDA.

    Finding Medical Device and Drug Approval Information Through the Fo…

    crsreports.congress.gov
    How do you get FDA approval for a medical device?
    To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use. The FDA does not have the authority to: Regulate a physician's or nurse's practice. FDA does not tell providers what to do when running their business or what they can or cannot tell their patients.

    FDA's Role in Regulating Medical Devices | FDA - U.S. Food and Drug

    fda.gov
    Who regulates medical device and drug products?
    This report also provides an overview of the FDA centers responsible for regulating medical device and drug products, brief summaries of the FDA’s approval processes for medical devices and drugs, references to additional CRS products on the FDA’s regulation of these products, and a glossary of terms. Table 1.

    Finding Medical Device and Drug Approval Information Through the Fo…

    crsreports.congress.gov
    Feedback
  11. Food and Drug Administration (.gov)
    https://www.fda.gov › medical-devices › pr…

    Products and Medical Procedures | FDA

    Oct 5, 2023 · Learn about the latest device approvals, including what medical uses the device is cleared or approved for, when it can be used, and when it should not be used. Find out which devices have been...

    Tags:
    US Food and Drug Administration
    FDA Device Guidance
    Medical Procedures
  12. Food and Drug Administration (.gov)
    https://www.fda.gov › search

    Search | FDA - U.S. Food and Drug Administration

    Tags:
    US Food and Drug Administration
    FDA Medical Device Database
  13. Food and Drug Administration (.gov)
    https://www.fda.gov › medical-devices › global-unique...

    AccessGUDID (for the public) | FDA

    Tags:
    US Food and Drug Administration
    FDA Approvals
    FDA Medical Device Database
  14. fda.gov
    https://www.accessdata.fda.gov › scripts › cdrh › cfdocs › ...

    Recognized Consensus Standards: Medical Devices - Food and …

    Tags:
    FDA Medical Devices
    Database
  15. AccessGUDID
    https://accessgudid.nlm.nih.gov

    AccessGUDID - Identify Your Medical Device

    Tags:
    FDA Medical Devices
    Unique Device Identification
  16. Food and Drug Administration (.gov)
    https://www.fda.gov › medical-devices › resources-you-medical-devices

    Resources for You (Medical Devices) | FDA - U.S. Food and Drug ...

    Tags:
    US Food and Drug Administration
    FDA and Medical Devices
    Device Listing with FDA
  17. Food and Drug Administration (.gov)
    https://www.fda.gov › medical-devices › unique-device...

    Global Unique Device Identification Database (GUDID) | FDA

    Tags:
    Medical device
    Unique Device Identification Database
  18. fda.gov
    https://www.accessdata.fda.gov › scripts › cdrh › cfdocs › ...

    OTC - Over The Counter - Food and Drug Administration

  19. CRS Reports
    https://crsreports.congress.gov › product › pdf
    [PDF]

    Finding Medical Device and Drug Approval Information …

    Tags:
    Medical device
    Food and Drug Administration
  20. scanmedicine.com
    https://scanmedicine.com

    ScanMedicine (NIHRIO) Searching Global Medical Innovation

    Tags:
    Medical Devices
    Database
  21. fda.gov
    https://www.accessdata.fda.gov › scripts › cdrh › cfdocs › ...

    Product Classification - Food and Drug Administration

    Tags:
    US Food and Drug Administration
    FDA and Medical Devices
  22. Nature
    https://www.nature.com › articles

    The state of artificial intelligence-based FDA-approved medical …

    Tags:
    US Food and Drug Administration
    Ai Medical Device Approved By FDA
  23. PubMed
    https://pubmed.ncbi.nlm.nih.gov

    The state of artificial intelligence-based FDA-approved medical …

    Tags:
    Medical Devices
    Artificial Intelligence
  24. nih.gov
    https://pmc.ncbi.nlm.nih.gov › articles

    The state of artificial intelligence-based FDA-approved medical …

  25. Food and Drug Administration (.gov)
    https://www.fda.gov › medical-devices › recently...

    Lumicell Direct Visualization System (DVS) – P230014 | FDA

  26. Food and Drug Administration (.gov)
    https://www.fda.gov › medical-devices › home-use...

    FDA's Role in Regulating Medical Devices | FDA - U.S. Food and …

    Tags:
    US Food and Drug Administration
    FDA and Medical Devices
    FDA Approvals
  27. Food and Drug Administration (.gov)
    https://www.fda.gov › patients › learn-about-drug-and-device-approvals

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

    Tags:
    US Food and Drug Administration
    FDA and Medical Devices
    FDA Approvals
  28. Food and Drug Administration (.gov)
    https://fda.gov › ... › medical-device-tracking

    Medical Device Tracking | FDA - U.S. Food and Drug Administration

    Tags:
    US Food and Drug Administration
    FDA and Medical Devices
    FDA Device Guidance
  29. Food and Drug Administration (.gov)
    https://www.fda.gov › medical-devices › software...

    Clinical Decision Support Software Frequently Asked Questions …

    Tags:
    Medical device
    Software
  30. PMDA
    https://www.pmda.go.jp › ... › drugs

    List of Approved Products | Pharmaceuticals and Medical …

  31. Food and Drug Administration (.gov)
    https://www.fda.gov › drugs › frequently-asked...

    How do I find out if a drug is approved? Is there a Web site I can …

    Tags:
    US Food and Drug Administration
    Drugs Approved By FDA
    FDA Drug Look Up
  32. Die Europäische Kommission
    https://ec.europa.eu › tools › eudamed

    EUDAMED - Die Europäische Kommission