BEUDAMED
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    ARIZONA CONDYLAR TIBIAL PLATEAU

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011862125220·Standard Band, Tooth 45/35, Size 25/Roth 22

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011862125180·Standard Band, Tooth 45/35, Size 25/Roth 18

    MALUC™ Total Hip Arthroplasty System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SUPERSTITCH 5F, 12F, AND EL

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

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 22, 2014

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·December 7, 2012

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·October 8, 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