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

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    HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DyeVert NG Contrast Modulation System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWERED NITRILE BLUE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·June 10, 2014

    SPRINT

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 8, 2010

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 28, 2012

    SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE

    FDA Adverse Event
    Malfunction ·CONMED ELECTROSURGERY·Product code HAM·September 11, 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