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

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    BOARD TO TRANSFER PARALYZED PATIENT FROM

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    VisAble.IO

    FDA 510(k)
    FDA Class 2 ·Radiology

    PICCOLO TRIGLYCERIDES TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PALODENT PLUS FORCEPS

    FDA Adverse Event
    Malfunction ·DENTSPLY CAULK·Product code DZN·February 28, 2014

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·November 16, 2007

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 25, 2009

    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