BEUDAMED
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    SYSTEMATE A AMYLASE HEM 67204

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EsophyX® Z Fastener Delivery Device

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

    IC-Flow™ Imaging System 2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·June 2, 2014

    CMF CUSTOMIZED IMPLANT KIT X-LARGE

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code KKY·October 25, 2012

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·September 20, 2010