BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    ZEISS VOICE CONTROL SYSTEM FOR OPMI'S

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

    OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CRW STEREOTACTIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

    DISSECTOR, 4.0MM X 13CM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code GFA·October 7, 2010

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·December 5, 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

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014