BEUDAMED
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    STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SURGICAL RETRACTOR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    LYSUS INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPSUREFIX MRI SURESCAN

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

    VIBRANT SOUNDBRIDGE

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MPV·December 5, 2012

    8800

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·September 27, 2010

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    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