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

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    MEROGEL INJECTABLE BIORESORBABLE STENT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    E220 Hygiene Delivery System

    FDA UDI
    Engle Dental Systems, LLC·00850043433323·Utility Center Mounted AS1 Delivery Hygiene System

    SPIROL EPIDURAL CATHETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SIMPLICITY WING INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2025

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·April 22, 2013

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    INVACARE·Product code BTI·September 9, 2014

    AED PRO

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 15, 2011

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 21, 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