BEUDAMED
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    BIOPSY KIT

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

    Jaeger

    FDA UDI
    Jaeger Medical GmbH·14250892907199·MicroGard IIB, Filter Kit

    Vyaire

    FDA UDI
    Jaeger Medical GmbH·14250892903146·MicroGard II, Filter Kit

    TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)

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

    DISPOSAL ECG ELECTRODES, MODEL EASYRODE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REVEL

    FDA Adverse Event
    Injury ·CAREFUSION 203, INC·Product code CBK·June 24, 2014

    SILHOUETTE PARADIGM

    FDA Adverse Event
    Death ·UNOMEDICAL A/S·Product code FPA·November 2, 2010

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 27, 2012

    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