BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    UNIVERSAL BUCKS TRACTION

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101155·DLEK CORNEAL DISSECTOR, ANGLED

    25-OH VITAMIN D ELISA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SaintView

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 1, 2014

    ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GEI·November 16, 2007

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 9, 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