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

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    RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RIVA LUTING

    FDA 510(k)
    FDA Class 2 ·Dental

    EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 12, 2024

    IDENTITY ADX SR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 31, 2013

    MICRO OSCILLATING SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·June 17, 2011

    HISTOACRYL FLEXIBLE PACK 5

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL SA·Product code MPN·February 11, 2020

    DELTAFILL10 3MM X 8CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022

    GALAXY G3 8MM X 24CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022

    HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML

    FDA Adverse Event
    Injury ·B. BRAUN SURGICAL SA·Product code MPN·February 26, 2020

    DELTAFILL10 2MM X 8CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022

    GALAXY G3 4MM X 12CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022

    GALAXY G3 8MM X 24CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022

    GALAXY G3 5MM X 15CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022

    DELTAFILL10 2MM X 8CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022

    GALAXY G3 5MM X 15CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022

    DELTAFILL10 2MM X 8CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022

    GALAXY G3 6MM X 20CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·November 9, 2022

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017