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

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    ETHOX LAVAGE TUBE

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

    INDIGO® Aspiration System – INDIGO Link

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DENTAL CHAIRS

    FDA 510(k)
    FDA Class 1 ·Dental

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·January 2, 2025

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

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

    NA

    FDA Adverse Event
    Malfunction ·STERILMED, INC.·Product code NUJ·December 5, 2012

    LAMITRODE S-8 LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 22, 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