BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    BINOCULAR OPER. MICROSCOPES & ACCESSOR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    EBCHEK BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES

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

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) PISTOL GRIP 36CM - 15MM ACTIVE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code GEI·October 9, 2007

    CAPTURE-R READY INDICATOR RED CELLS

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·November 7, 2012

    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