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

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    CrossGlide ETS Plus

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

    Blade Handle

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112380·BARD-PARKER HANDLE #3

    HIVOX DREAMATE DM-800

    FDA 510(k)
    FDA Class 2 ·Neurology

    KONIX ULTRASOUND GEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    EMBLEM S-ICD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·October 6, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

    ACCELSTIM

    FDA Adverse Event
    Injury ·ORTHOFIX·Product code LOF·June 5, 2023

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 17, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·August 11, 2011

    STRETCHER CHAIR

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 2, 2013

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·December 4, 2024

    HARMONIC ACE 5MM SHEAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 20, 2021

    HARMONIC ACE 5MM SHEAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 20, 2021

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·February 27, 2024

    HARMONIC ACE 5MM SHEAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 29, 2024

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025