BEUDAMED
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    DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ELVIS HSV ID AND D3 TYPING TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 24, 2014

    FLOSEAL

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - HAYWARD·Product code LMF·November 5, 2010

    EVIA SR-T PROMRI

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·November 21, 2012

    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