BEUDAMED
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    ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268212491·CUSTOM SURGICAL KIT ENDOVENOUS PACK

    MULTIARRAY KIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    SURGASSIST FLEXSHAFT 2, MODEL FS2 14

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

    CARE ASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVINGER·Product code FNL·April 28, 2014

    PLASMABLADE TISSUE DISSECTION DEVICE

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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 5, 2015

    Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·October 10, 2018

    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