BEUDAMED
    16 results · 29ms · Sources: EU EUDAMED, US FDA

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    INTEL HEALTH GUIDE, MODEL: PHS6000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code GWF·November 27, 2013

    RUSCH CANTOR TUBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TALON BALLOON DILATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NIM-ECLIPSE® ELECTRODE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code GXZ·May 16, 2016

    NIM-ECLIPSE® ELECTRODE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code GXZ·May 6, 2016

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014

    VISION HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·GISH BIOMEDICAL, INC.·Product code DTZ·February 18, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 16, 2015

    GYRUS A

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code HIH·September 5, 2014

    AU681-02E CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JJE·May 6, 2011

    DIGITAL PREAMPLIFIER

    FDA Adverse Event
    Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·May 9, 2026

    CONTROLLER ECLC ECLIPSE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·May 23, 2014

    IPC® HANDPIECE - STYLUS TOUCH®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code HBE·December 11, 2019

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014