BEUDAMED
    7 results · 35ms · Sources: EU EUDAMED, US FDA

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    SOPHEIA GENTAMICIN EIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    QUIKCLOT HEMOSTATIC DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    CLINITRON RITEHITE

    FDA Adverse Event
    HILL-ROM, INC.·Product code INX·February 28, 2014

    SMALL GRASPING RETRACTOR INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 7, 2012

    ASSURANT COBALT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIO·June 8, 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