BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    CLAMP ON HOLDER FOR A GLASS OR CUP

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    OPTIMA CT520

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 1, 2014

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Other ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·October 30, 2012

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 27, 2010

    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