BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    PEM-T

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NAIL HOLDING SCREW

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·January 6, 2012

    FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION

    FDA 510(k)
    FDA Class 2 ·Neurology

    TECNIS

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code HQL·May 23, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 10, 2012

    ENDO CATCH II 15MM SPECIMEN POUCH

    FDA Adverse Event
    Malfunction ·DAVIS AND GECK CARIBE, LTD.·Product code GCI·September 2, 2010

    ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·August 14, 2019

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015