BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    SofWave System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    XYLOS SURGICAL MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ZERONA 2.0 LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 17, 2019

    VITROS IMMUNODIAGNOSTICS PRODUCTS TROPI ES REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·November 4, 2014

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 12, 2011

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 12, 2013

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·June 27, 2018

    ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DQY·December 6, 2021

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024