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

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    CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Intense Pulsed Light Treatment System

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

    ZUMA-C

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYSTEM 6 NON STERILE BATTERY

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·November 2, 2010

    TOTALCARE BARIATRIC

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·November 26, 2012

    PRECISION SPECTRA®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 24, 2014

    MEDEX

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPB·December 30, 2021

    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