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

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    MEDSAT OXYGEN SATURATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IRIS INTELLIGENT RETINAL IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    PUMP IN STYLE ADVANCED BREAST PUM METRO BAG

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·June 9, 2014

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·February 4, 2013

    ACRYSOF RESTOR

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD./ HUNTINGTON·Product code MFK·December 22, 2010

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024