BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    NS-HGlio

    FDA 510(k)
    FDA Class 2 ·Radiology

    5221738

    FDA Adverse Event
    Malfunction ·November 13, 2015

    GALILEO ECHO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·December 20, 2011

    MYVISIONTRACK(TM)

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES

    FDA 510(k)
    FDA Class 2 ·Radiology

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·August 12, 2025

    KEEPSAFE DELUXE NO POWER SWITCH

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·August 17, 2011

    MODULAR CAPTURE - DISTAL RESECTION

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·November 3, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 11, 2013

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 29, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 10, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 22, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·December 27, 2025

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·September 16, 2025

    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

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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