BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    F.M. WEIST,KG (URODYNAMIC SYSTEMS)

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

    cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 15, 2014

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·December 5, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 22, 2015

    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