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

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    CardioChek Plus Test System; CardioChek Plus Home Test System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    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

    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

    CARDIOCHEK PLUS ANALYZER

    FDA Adverse Event
    Malfunction ·PTS DIAGNOSTICS·Product code CGA·May 18, 2023

    CARDIOCHEK PLUS ANALYZER

    FDA Adverse Event
    Malfunction ·PTS DIAGNOSTICS·Product code CGA·November 11, 2022

    CARDIOCHEK PLUS ANALYZER

    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, 2022

    Cardiovascular Procedure Kit

    FDA UDI
    Terumo Cardiovascular Systems Corporation·00699753534957·

    MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519

    FDA 510(k)
    FDA Class 2 ·General Hospital