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

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    VITA Ambria

    FDA 510(k)
    FDA Class 2 ·Dental

    FIRST RESPONSE EARLY RESULT PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 23, 2025

    CARDIOCHEK PLUS ANALYZER

    FDA Adverse Event
    Malfunction ·PTS DIAGNOSTICS·Product code CGA·June 16, 2025

    CARDIOCHEK PLUS ANALYZER

    FDA Adverse Event
    Malfunction ·PTS DIAGNOSTICS·Product code CGA·June 16, 2025

    1823260-2017-00582

    FDA Adverse Event
    Malfunction ·March 20, 2017

    CARDIOCHEK PLUS ANALYZER

    FDA Adverse Event
    Malfunction ·PTS DIAGNOSTICS·Product code CGA·October 22, 2025

    CARDIOCHEK PLUS ANALYZER

    FDA Adverse Event
    Malfunction ·PTS DIAGNOSTICS·Product code CGA·February 12, 2025

    ITREL 3

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 7, 2008

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 27, 2013

    VENTILATOR, CONTINUOUS, FACILITY USE

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·July 13, 2011

    CARDIOCHEK PLUS ANALYZERQ

    FDA Adverse Event
    Malfunction ·PTS DIAGNOSTICS·Product code CGA·August 18, 2022

    CARDIOCHEK PLUS ANALYZER

    FDA Adverse Event
    Malfunction ·PTS DIAGNOSTICS·Product code CGA·July 28, 2023

    CARDIOCHEK PLUS ANALYZER

    FDA Adverse Event
    Malfunction ·PTS DIAGNOSTICS·Product code CGA·May 24, 2024

    CARDIOCHEK PLUS ANALYZER

    FDA Adverse Event
    Malfunction ·PTS DIAGNOSTICS·Product code CGA·January 6, 2023

    CARDIOCHEK PLUS ANALYZER

    FDA Adverse Event
    Malfunction ·PTS DIAGNOSTICS·Product code CGA·January 11, 2024

    CARDIOCHEK PLUS ANALYZER

    FDA Adverse Event
    Malfunction ·PTS DIAGNOSTICS·Product code CGA·November 21, 2023

    CARDIOCHEK PLUS ANALYZER

    FDA Adverse Event
    Malfunction ·PTS DIAGNOSTICS·Product code CGA·June 14, 2024

    CARDIOCHEK PLUS ANALYZER

    FDA Adverse Event
    Malfunction ·PTS DIAGNOSTICS·Product code CGA·February 24, 2023