BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    DEMI-WALKER (REGULAR)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S

    FDA 510(k)
    FDA Class 2 ·Hematology

    iFuse Implant System- iFuse Navigation

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·October 4, 2012

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 19, 2013

    PINN MAR LIP LNR 32IDX60OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 22, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    ACCOLADE SR SL MRI (Model L310)

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