BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    AngioWaveNet

    FDA 510(k)
    FDA Class 2 ·Radiology

    InSitu Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00810030810292·Femoral Head, 40mm, +4mm, Ceramic

    STILLE Retractors

    FDA UDI
    Stille AB·07332339205546·RETRACTOR STILLE 2 sharp prongs 6 mm 18 cm 7 in

    MICROCUFF ENDOTRACHEAL TUBE

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC. (FORMERLY HALYARD HEALTH INC.)·Product code BTR·September 13, 2024

    MICROCUFF ENDOTRACHEAL TUBE

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC. (FORMERLY HALYARD HEALTH INC.)·Product code BTR·September 13, 2024

    ICEfx Cryoablation System (FPRCH8000-02)

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

    CRYOcheck Chromogenic Factor IX

    FDA 510(k)
    FDA Class 2 ·Hematology

    ALINITY C CALCIUM2

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CJY·March 5, 2026

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    FDA Adverse Event
    TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·August 30, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 24, 2013

    ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·July 19, 2017

    ACCOLADE DR SL MRI (Model L311)

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