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

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    Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    I-PORT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code OAD·August 26, 2014

    CURVED EEA 31 STAPLER

    FDA Adverse Event
    Injury ·PONCE - USS·Product code GDW·December 4, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 17, 2011

    GYNECARE X-TRACT MOTOR DRIVE UNIT

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code HET·July 29, 2013

    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