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

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    TISSUE FORCEPS

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

    MYOSURE INTRUMENT TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INION HEXALON BIODEGRADABLE ACL/PCL SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERSACARE BED

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

    PLASMABLADE TISSUE DISSECTION DEVICE

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

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·August 26, 2010

    XP-CR Tibial Tray - Interlok 67mm Item # 195271

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    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