BEUDAMED
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    MYOLAB II, MODEL ML-200

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Ax Stand-Alone ALIF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·October 8, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 23, 2014

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·December 7, 2012

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012