BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    CELERITY HP Indicator Tape (PCC077)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MLKJ

    FDA UDI
    Weifang Mingliang Electronics Co., Ltd.·06974077940023·

    DIAZYME SODIUM ENZYMATIC ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Graffiti

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 11, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·July 23, 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