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

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    BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    YellowStar

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

    NEWPORT E500 WAVE VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    E500 VENTILATOR SYSTEM

    FDA Adverse Event
    Injury ·NEWPORT MEDICAL INSTRUMENTS, INC·Product code CBK·July 11, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2014

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 8, 2010

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 4, 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