BEUDAMED
    25 results · 27ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Radiology

    AGXO

    FDA UDI
    Oticon A/S·05707131341471·G200, BTE 13 2.4G 85 C091 AGXO

    SINGLE-PATIENT USE DISPOSABLE SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIO 7

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    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

    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

    ISOFLEX S

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

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 27, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·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

    CARDIOCHEK PLUS ANALYZER

    FDA Adverse Event
    Malfunction ·PTS DIAGNOSTICS·Product code CGA·June 7, 2023