BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    SCHNEIDER-SHILEY PRESSURE MANOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Smart External Drain (SED) System

    FDA 510(k)
    FDA Class 2 ·Neurology

    NEMIO XG, SAA-580A

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 8, 2010

    INFINITI VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·November 28, 2012

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    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