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

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    StitchKit

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

    ALARIS SMARTSITE

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·January 26, 2026

    SECTRA OSTEOPOROSIS PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    WI-FI BODY SCALE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·May 3, 2023

    BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·May 3, 2023

    RESPIRATORY HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·November 5, 2008

    TRIATHLON PS X3 TIBIAL INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·August 11, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 11, 2013

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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