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

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    THORATEC GAS SAMPLING CONNECTOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    REMSTAR SE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 7, 2014

    FAST-CATH HEMO. INT., 8.5F, SWARTZ SL1, TRANS.

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. (AF-MINNETONKA)·Product code DYB·November 2, 2012

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·August 27, 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