BEUDAMED
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    VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH.

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

    Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns

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

    BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 10, 2014

    5MM X 32CM STRYKEPROBE OUTER SHEATH REPLACEMENT

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code GEI·November 5, 2012

    AXXESS QUAD 3/6 LEAD

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·September 24, 2010

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012