BEUDAMED
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    3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)

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

    Steerable Guide Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIO-MED CORP. DISP. NON-STERILE TRANSDU

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2014

    SCULPTRA

    FDA Adverse Event
    Injury ·SANOFIAVENTIS U.S., LLC.·Product code LMH·October 6, 2010

    ZOOM CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·October 31, 2012

    Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL 5420 AB GEMERT --- Shipping or Unit Package: 20 individual units packaged per box with 6 boxes per case. --- Device Classification Name: Electrode, pacemaker, temporary. ---The device is supplied sterile and intended for single use. Used to pace the heart during or after open heart surgery. The electrodes are placed on the heart; the other end of the pacing wire is inserted through the skin of the patient with a thoracic needle. The thoracic needle can snap-off at the end where the pacing wire is attached, after snap-off the remaining pins are connected to an external pacemaker. For temporary atrial and ventrical pacing and sensing for contemplated implant duration of 7 days or less.

    FDA Recall
    Terminated ·European Custom Manufacturing B.V. Oost-Om 54 Gemert Netherlands·Product code LDF·April 18, 2011

    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