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

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    TRI-TUBE RIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO AVANT 9600 PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 20, 2012

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 30, 2014

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·September 22, 2010

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·September 26, 2024

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·September 30, 2024

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·December 6, 2024

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·November 5, 2024

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 26, 2024

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·November 13, 2024

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 31, 2024

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 6, 2024

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·December 4, 2024

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 13, 2024

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·January 7, 2025

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·January 13, 2025

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·January 23, 2025

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017