BEUDAMED
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    Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113813·VISCO CANNULA 27GA ANGLE 8MM

    Empower Clear Bracket

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746200397·COSMETIC SL EMPOWER CLEAR INTERACT LL ANT 022 T...

    Empower Clear

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746000881·COSMETIC SL EMPOWER CLEAR INTERACT LL ANTERIOR ...

    Empower Clear

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746154522·COSMETIC SL EMPOWER CLEAR INTERACT LL ANT 022 T...

    PROMOTOR

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

    DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A

    FDA 510(k)
    FDA Class 2 ·Radiology

    1823260-2017-02599

    FDA Adverse Event
    Malfunction ·November 14, 2017

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    ULTRAFLEX¿ TRACHEOBRONCHIAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code JCT·August 25, 2011

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 10, 2013

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026

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

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

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    ACCOLADE DR SL MRI (Model L311)

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