BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    POROCOAT MARK IV ELBOW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SONOREAL 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    HOPER PTCA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 28, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 5, 2012

    ON-Q PAINBUSTER

    FDA Adverse Event
    Other ·I-FLOW CORPORATION·Product code MEB·August 25, 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