BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    MICROVEL DOUBLE VELOUR SUPPORTED 100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BUN/GLUCOSE STANDARDS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TOXCUP DRUG SCREEN CUP

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014

    GRAPHIC CASE

    FDA Adverse Event
    Malfunction ·Product code NKB·November 7, 2012

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NKB·August 27, 2010

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 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