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

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    DISPOSABLE SURGICAL GARMENTS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    N/A

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788203630·Sterilization_Tray_2.6_x16_x1.5

    GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SYNGO RT INTERFACE

    FDA 510(k)
    FDA Class 2 ·Radiology

    NATURLYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code MMH·November 6, 2012

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 5, 2015

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 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