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    RADIOMETER AMERICA, INC.

    FDA registration
    RADIOMETER AMERICA, INC.·2 products·🇺🇸 United States

    VKR-5

    FDA UDI
    RADIOMETER AMERICA INC.·00860003561942·Kit of QC material for the validation of sensor...

    Safe PICO Kit

    FDA UDI
    RADIOMETER AMERICA INC.·10860003561925·1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Steri...

    VKR-7

    FDA UDI
    RADIOMETER AMERICA INC.·00860003561959·Kit of QC material for the validation of sensor...

    VK-3

    FDA UDI
    RADIOMETER AMERICA INC.·00860003561935·Kit of QC material for the validation of sensor...

    Safe PICO Kit

    FDA UDI
    RADIOMETER AMERICA INC.·00860003561904·1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Steri...

    safePICO

    FDA UDI
    RADIOMETER AMERICA INC.·00860003561928·1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Steri...

    safePICO

    FDA UDI
    RADIOMETER AMERICA INC.·01860003561927·1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Steri...

    VK-CREA

    FDA UDI
    RADIOMETER AMERICA INC.·00860003561966·Kit of QC material for the validation of sensor...

    Safe PICO Kit

    FDA UDI
    RADIOMETER AMERICA INC.·10860003561901·1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Steri...

    safePICO

    FDA UDI
    RADIOMETER AMERICA INC.·01860003561903·1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Steri...

    ABL800 FLEX

    FDA Adverse Event
    Malfunction ·RADIOMETER MEDICAL APS·Product code CHL·September 14, 2017

    pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.

    FDA Enforcement
    Class II ·Terminated·Radiometer America Inc·March 5, 2014

    pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).

    FDA Enforcement
    Class II ·Terminated·Radiometer America Inc·January 22, 2014

    TCM CombiM Modules 903-111

    FDA Enforcement
    Class II ·Terminated·Radiometer America Inc·May 11, 2016

    TOSCA 500 USA

    FDA Adverse Event
    Injury ·RADIOMETER AMERICA, INC.·Product code DQA·September 8, 2015

    SAFEPICO

    FDA Adverse Event
    Malfunction ·RADIOMETER AMERICA, INC·Product code CBF·May 15, 2014

    SAFEPICO

    FDA Adverse Event
    Malfunction ·RADIOMETER AMERICA, INC.·Product code CBT·July 9, 2015

    RADIOMETER

    FDA Adverse Event
    Malfunction ·RADIOMETER AMERICA, INC.·Product code CHL·January 6, 1997

    RADIOMETER

    FDA Adverse Event
    Malfunction ·RADIOMETER AMERICA, INC.·Product code CHL·January 6, 1997