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

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    CALCITONIN RIA TEST KIT, DLS 1200

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268216751·CUSTOM SURGICAL KIT VEIN PACK

    VERSAVIT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    United U2 femoral head, 22mm delta ceramic head

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 20, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 6, 2012

    LIGACLIP*MCA MED

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDO·August 31, 2010

    LCP(TM) DISTAL FEMUR PLATE 11 HOLES/276MM-RIGHT

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code HRS·October 3, 2017

    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