BEUDAMED
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    KONTRON CUTANEOUS PO2 MONITOR 820

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Philips Efficia CMS200 Central Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEVON COOL FACE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CAPSUREFIX MRI SURESCAN

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 6, 2012

    SPRINT FIDELIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 7, 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