BEUDAMED
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    Edwards Pressure Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARSENAL PETITE LAPIDUS PLATE, R

    FDA Adverse Event
    Injury ·TRILLIANT SURGICAL·Product code HRS·April 3, 2020

    NMI PICC III

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 26, 2013

    VASOVIEW HEMOPRO EVH SYSTEM

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·July 29, 2011

    OUTLOOK 100

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code FRN·September 26, 2008

    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