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

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    PATIENT EXAMINATION GLOVES (LATEX)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327370850·FacialiD-Orthog-Priority-4Plates

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123069·K-WIRE - DOUBLE TROCAR 1.0mm DIA x 100mm

    Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    X SERIES

    FDA Adverse Event
    Death ·ZOLL MED CORP·Product code MKJ·June 19, 2014

    SYNERGY

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 2, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·November 3, 2010

    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