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

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    Sublime Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Oticon A/S·05714464008353·OTICON MORE 3 MINIRITE R C092

    CAPTURE-R READY-SCREEN 3

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code QHT·November 27, 2021

    SAVINA 300 SAVINA 300, COUNTRY VARIANTS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ACCOLADE STEM

    FDA Adverse Event
    Injury ·STYKER ORTHOPAEDICS CORK·Product code MEH·November 4, 2008

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·August 24, 2011

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 9, 2013

    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