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

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    3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971659·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172972274·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971642·

    SMARTLUX

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

    HELFET ELBOW PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 9, 2014

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 31, 2012

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·August 30, 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