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

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    CONCHO PEDIATRIC PACK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LYPHOCHEK HEMOSTASIS, MODELS 798, 799

    FDA 510(k)
    FDA Class 2 ·Hematology

    Straumann TLX Variobase C

    FDA 510(k)
    FDA Class 2 ·Dental

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 13, 2014

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 6, 2012

    PROLIEVE THERMODILITATION SYSTEM

    FDA Adverse Event
    Injury ·ACCELLENT ENDOSCOPY JUAREZ·Product code MEQ·August 31, 2010

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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