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

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    THE HOLTER REPORTER (TM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRATINE FOREHEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRA Telescopes

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARELINK

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

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 7, 2010

    TOTALCARE BARIATRIC

    FDA Adverse Event
    Other ·HILL-ROM, INC.·Product code FNL·November 26, 2012

    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