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

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    Eva Scalp Cooling System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011252289200·ceraMotion® Me Transpa Modifier Value lemon, 20...

    DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Alians Elbow Locking Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 14, 2014

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·September 16, 2011

    PELVICOL 4 X 12 CM

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TISSUE·Product code FTL·July 22, 2013

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

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