BEUDAMED
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    GENERAL SURGICAL TABLE AND ACCESSORIES

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

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code MNT·July 9, 2015

    V60 VENTILATOR, MODEL V8000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GaltTWS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code MNT·August 3, 2015

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 19, 2014

    EON MINI 16-CHANNEL IPG

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·October 13, 2010

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 20, 2012

    GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·April 1, 2015