BEUDAMED
    8 results · 34ms · Sources: EU EUDAMED, US FDA

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    KODAK X-OMAT PROCESSOR, MODEL ME-3

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAROTID ACCESS KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Dentiq3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    START-X TIP EMS INSERT 3

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code ELC·January 27, 2025

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 10, 2014

    EASYTRAK 3

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·October 7, 2010

    ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP·Product code FRN·October 26, 2012

    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