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

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    CARBON DIOXIDE ABSORBENTS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PREMIER® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490482257·PLATE 6860147 47.5MM ANTERIOR CERVICAL

    CT TrueView

    FDA 510(k)
    FDA Class 2 ·Radiology

    POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

    ICEROD MRI NEEDLE

    FDA Adverse Event
    Malfunction ·GALIL MEDICAL LTD.·Product code OCL·November 21, 2012

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 22, 2015

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 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