BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    SMYLON (DENTAL STAIN ERASER)

    FDA 510(k)
    FDA Class 1 ·Dental

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011891338000·50 cases Topic Roth 18,with hooks Brackets / Fo...

    DUAL HEAD STETHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLLASORB COLLAGEN WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 31, 2014

    TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 4, 2010

    MX-PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·November 29, 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