BEUDAMED
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    DRY TIPS

    FDA 510(k)
    FDA Class 1 ·Dental

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756196239·LAP CHOLE BASIN SET

    EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Linshom Respiratory Monitoring Device (LRMD)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    STEAM STER LOCKS ORANGE

    FDA Adverse Event
    Injury ·AESCULAP INC·Product code KCT·October 12, 2016

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 3, 2014

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code NTE·October 28, 2010

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 31, 2012

    STEAM STER LOCKS ORANGE

    FDA Adverse Event
    Malfunction ·AESCULAP INC·Product code KCT·July 26, 2016

    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