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

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    COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    XPS® HANDPIECE - VISAO®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·December 9, 2015

    XPS® HANDPIECE - VISAO®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·January 8, 2016

    MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VitalStim(R) Plus Electrotherapy System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    XPS HANDPIECE - VISAO

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·November 2, 2021

    DRILL 3334800 VISAO 80K HANDPIECE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code ERL·July 2, 2013

    XPS® HANDPIECE - VISAO®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017

    XPS® HANDPIECE - VISAO®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017

    CAPSURE SENSE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·February 9, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 23, 2014

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIM·January 7, 2011

    XPS® HANDPIECE - VISAO®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·June 9, 2016

    enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·May 24, 2017