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

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    HALSTEAD MOSQUITO FORCEPS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PIXEL APP

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PENTA

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 9, 2014

    PULSAR GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012

    ACCU-CHEK SPIRIT CARTRIDGE

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·August 26, 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