BEUDAMED
    10 results · 25ms · Sources: EU EUDAMED, US FDA

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    Serranator PTA Serration Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·March 22, 2020

    GYRUS ACMI PK BUTTON ELECTRODE

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

    ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEARTSINE GATEWAY 500P BUNDLE SALES BOM - UK ENGLISH

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·December 8, 2025

    OMNIFIX®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FMF·March 6, 2026

    SPACEMAKER STRUCTURAL BALLOON TROCAR

    FDA Adverse Event
    Malfunction ·PONCE - USS·Product code GCJ·October 7, 2008

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 27, 2013

    PUMP IN STYLE BREAST PUMP

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·July 21, 2011

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022