BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    ACS COLLOID OSMOTIC PRESSURE CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198529·AK3 Ultra Insert Trial Size 2, 13mm

    WHITE KNIGHT BOVIE CORD/SUCTION TUBE

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

    RENAL SYSTEMS HEMODIALYSIS CONCENTRATE

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

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 10, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·November 2, 2010

    VENTRALIGHT ST MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·December 21, 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