BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    MIN-MOLECULE PTH BY RADIOIMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 20, 2014

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·October 31, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 4, 2015

    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