BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    TRACHEOBRONCHIAL SUCTION CATHETER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    VISUM LED SURGICAL LIGHTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Infrared Forehead Thermometer, FT-100A

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 14, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·December 5, 2012

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NIK·June 22, 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

    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