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

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    SHIELY DUEL LUMEN SUBCLAVIAN CANNULA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Securi-T

    FDA UDI
    HOLLISTER INCORPORATED·00610075070152·2-Pc Ostomy System, Convex

    STRADIS HEALTHCARE

    FDA UDI
    STRADIS MEDICAL, LLC·M75268221340·

    JK INT'L, INC. SOLTRON UVA TANNING BED

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

    FLEXLITE CAMERA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 20, 2014

    PULSAR GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012

    OUTBACK LTD

    FDA Adverse Event
    Malfunction ·CORDIS CORPORATION·Product code DQY·August 23, 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