BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    P-S CSF-VENTRICULAR CATHETER, FLANGED

    FDA 510(k)
    FDA Class 2 ·Neurology

    DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SKINTACT ECG ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 19, 2014

    INNOVA 4100

    FDA Adverse Event
    Death ·GE MEDICAL SYSTEMS SCS·Product code MQB·August 1, 2008

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 2, 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