BEUDAMED
    22 results · 22ms · Sources: EU EUDAMED, US FDA

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    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code GWF·October 4, 2013

    ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON

    FDA 510(k)
    FDA Class 2 ·Neurology

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code GWF·February 20, 2018

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code GWF·December 2, 2013

    NIM-ECLIPSE® PATIENT MODULE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·December 6, 2017

    PROBE SPK1004 SURGEON CONTROLLED

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·May 17, 2013

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·December 14, 2015

    NIM-ECLIPSE® CONTROLLER

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

    COMPUTER NOTEBOOK (INTERNATIONAL

    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

    NIM-ECLIPSE PREAMPLIFIER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·July 7, 2021

    COMPUTER NOTEBOOK (INTERNATIONAL)

    FDA Adverse Event
    Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·April 13, 2026

    TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTERMED ZOOM COLPOSCOPE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 16, 2013

    CATHETER - ABLATION

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC.·Product code OAD·June 8, 2008

    ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 18, 2011

    Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021