BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    GLOBAL ECG MANAGEMENT SYSTEM (GEMS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENLUXTRA HUMIFIBER WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·June 3, 2020

    SPARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 11, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 5, 2014