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

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    AXON ECLIPSE CONTROLLER

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

    ECLIPSE NEUROLOGICAL WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Neurology

    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

    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

    DRYVIEW DVM Mammography Laser Imaging Film

    FDA UDI
    CARESTREAM HEALTH, INC.·40889971050799·100SH 5850 20X25CM 8X10IN) DVM (2PK) CE

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450046951·

    RUSCH CANTOR TUBE

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

    TALON BALLOON DILATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZILVER 518 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 21, 2017

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·March 15, 2013

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

    ZILVER 518 SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·October 26, 2012

    Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·October 23, 2024

    Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code OEQ·August 19, 2024