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    Coapt LLC

    FDA registration
    Coapt LLC·3 products·🇺🇸 United States

    ControlSeal Electrode Domes (Standard Size)

    FDA UDI
    COAPT LLC·B618E4·Non-invasive, cutaneous electrode for use with ...

    Coapt Evaluation Kit

    FDA UDI
    COAPT LLC·B618Q1·The Coapt Evaluation Kit is a handheld clinical...

    COMPLETE CONTROL System Gen2

    FDA UDI
    COAPT LLC·B618N1·The COMPLETE CONTROL System Gen2 is an advanced...

    ControlSeal Electrode Domes (Large Size)

    FDA UDI
    COAPT LLC·B618E3·Non-invasive, cutaneous electrode for use with ...

    ControlSeal Electrode Domes (Standard Size)

    FDA UDI
    COAPT LLC·B618E2·Non-invasive, cutaneous electrode for use with ...

    Gen2 System Kit

    FDA UDI
    COAPT LLC·B618P1·The Gen2 System Kit is a medical device kit tha...

    Complete Co-Amp

    FDA UDI
    COAPT LLC·B618C0·8-Channel EMG Front End Processing Unit

    Dome Electrodes

    FDA UDI
    COAPT LLC·B618E0·Non-invasive, cutaneous electrode for use with ...

    Complete Controller

    FDA UDI
    COAPT LLC·B618A0·Pattern Recognition Processing Unit

    Complete Calibrate

    FDA UDI
    COAPT LLC·B618D0·Socket-Mount Calibration Unit

    ControlSeal Electrode Domes (Standard Size)

    FDA UDI
    COAPT LLC·B618E1·Non-invasive, cutaneous electrode for use with ...

    Complete Communicator

    FDA UDI
    COAPT LLC·B618B0·PC-Side Wireless Radio Receiver Unit

    ControlSeal Electrode Domes (Large Size)

    FDA UDI
    COAPT LLC·B618E5·Non-invasive, cutaneous electrode for use with ...

    Coapt Dome Electrode, Gen2 system, cutaneous electrode

    FDA Recall
    Open, Classified ·Coapt LLC·Product code GXY·October 2, 2023

    Coapt ControlSeal Electrode, cutaneous EMG Electrode

    FDA Recall
    Open, Classified ·Coapt LLC·Product code GXY·October 2, 2023

    COAPT DOME ELECTRODE

    FDA Adverse Event
    Injury ·COAPT, LLC·Product code GXY·September 19, 2023

    CONTROLSEAL ELECTRODE

    FDA Adverse Event
    Injury ·COAPT LLC·Product code GXY·September 19, 2023

    Coapt ControlSeal Electrode, cutaneous EMG Electrode

    FDA Enforcement
    Class II ·Ongoing·Coapt LLC·November 8, 2023

    Coapt Dome Electrode, Gen2 system, cutaneous electrode

    FDA Enforcement
    Class II ·Ongoing·Coapt LLC·November 8, 2023