BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    VACO SUCTION ELECTRODE UNIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PeriCoach OTC

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OR HEAD COIL 1.5 T

    FDA 510(k)
    FDA Class 2 ·Radiology

    TARGET DEVICE 300X160MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·March 2, 2012

    MYOCARDIAL LEAD

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

    FLO GARD6201 COMPATIBLE BLOODSET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·October 7, 2010

    UNKNOWN DEEP BRAIN STIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·December 6, 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