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

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    FROG Forceps Valve (VAL1-F1-100)

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

    TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVATING SEAT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    GALILEO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·November 21, 2008

    ULTRASAFE PLUS X100L PNG CLEAR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MEG·February 21, 2021

    GALILEO ECHO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·December 17, 2014

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR GALWAY·Product code NIM·November 5, 2008

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    FDA Adverse Event
    Injury ·CAREFUSION CORP.·Product code FPA·August 17, 2011

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 2013

    AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04

    FDA Enforcement
    Class II ·Terminated·Avid Medical, Inc.·March 7, 2018

    Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021