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

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    MICROSURGICAL INSTRUMENTS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    DISPOSABLE TEMPORARY PACING WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CENTRICITY PACS-IW WITH UNIVERSAL VIEWER

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 5, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 7, 2012

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 6, 2015

    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