BEUDAMED
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    ANDROSTENEDIONE 125I KIT BY RIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ZOLL R SERIES DEFIBRILLATOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    NOBLUS™ Ultrasound Diagnostic System

    FDA 510(k)
    FDA Class 2 ·Radiology

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 15, 2014

    VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·October 7, 2010

    GII STANDARD TIBIA B

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·December 6, 2012

    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