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

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    EM STRESS ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100

    FDA 510(k)
    FDA Class 2 ·Radiology

    Pantheris Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAVERICK2 MONORAIL PTCA CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LOX·February 9, 2007

    9900

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

    HUDSON RCI ADULT VENTILATOR CIRCUITS, HEATED-WIRES

    FDA Adverse Event
    ARROW INTERNATIONAL TELEFLEX·Product code BZO·October 1, 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