BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    MULTI PURPOSE MODEL 76-903

    FDA 510(k)
    FDA Class 1 ·Radiology

    MICROPOWER HAND PIECE HIGH SPEED DRILL

    FDA 510(k)
    FDA Class 2 ·Neurology

    Tempo Temporary Pacing Lead

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARELINK

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

    ACUMATCH M-SERIES

    FDA Adverse Event
    Other ·EXACTECH, INC.·Product code LPH·November 29, 2012

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTN·June 22, 2015

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    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