BEUDAMED
    29 results · 27ms · Sources: EU EUDAMED, US FDA

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    AMIGO INSULIN PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Gerber RZ

    FDA UDI
    Cendres+Métaux SA·07640166513704·Gerber RZ Base O with threaded post

    Cardinal Health

    FDA UDI
    HYGIA HEALTH SERVICES, INC.·10817357022206·Cardinal Health Flexiport Small Adult

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306813016·Strabismus Scissors, Straight, 10cm

    EndoAVF® Balloon Inflation Kit

    FDA UDI
    Merit Medical Systems, Inc.·00884450413838·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450483862·

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103120·Shaver, Closed, 12mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024076·Paddle Shaver, 12mm

    Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code OEQ·August 19, 2024

    VARELISA SM ANTIBODIES

    FDA 510(k)
    FDA Class 2 ·Immunology

    ULTIMA SNORING MIKE, MODEL 0540

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    audifon

    FDA UDI
    audifon GmbH & Co. KG·EADF021338805031217201·BTE-TRT

    Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·October 23, 2024

    AEQ REV II GLENOID BASEPLATE DIA 25MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code PHX·July 1, 2025

    AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·March 13, 2025

    AEQ REV GLENOID BASEPLATE 29MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·March 6, 2025

    ENDOVIVE 3S LOW PROFILE BALLOON KIT

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·January 11, 2016

    HI TORQUE CONNECT GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BRIVANT, LTD.·Product code DQX·March 13, 2013

    REZOOM

    FDA Adverse Event
    Injury ·ADVANCED MEDICAL OPTICS·Product code MFK·May 22, 2008

    STARCLOSE

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·April 6, 2011