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

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    LEECO T4 QUANT DIAGNOSTICS TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Tranquil-C™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788223990·Cervical Rasp + DS 12x18x14 Flat

    BLACKSTONE SPINAL FIXATION SYSTEM SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODEL 2500 PNEUMATIC PERCUSSOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2014

    EXPEDIUM DI INTERMEDIATE TIGHTENER

    FDA Adverse Event
    Malfunction ·DEPUY RAYNHAM·Product code LXH·November 7, 2012

    NEONATAL VENTILATOR CIRCUITS, HEATED-WIRE

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL HUDSON RCI·Product code BZO·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