BEUDAMED
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    STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES

    FDA 510(k)
    FDA Class 2 ·Neurology

    CYBER 120 HEMODIALYZER

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

    APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SIGMA 300 SR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·June 10, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·December 7, 2012

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. (CRM-KISTA)·Product code NVN·June 23, 2015

    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