BEUDAMED
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    SLEEPER JACKET/HOUDINI SAFETY SLEEPER

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TRUEHD (1080P) DIGITAL CAMERA SYSTEM

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

    NeuraGen 3D Nerve Guide Matrix

    FDA 510(k)
    FDA Class 2 ·Neurology

    HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 21, 2014

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 15, 2013

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·December 20, 2010

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015