BEUDAMED
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    Gentuity, LLC

    Manufacturer
    🇺🇸 United States

    GENTUITY, LLC

    FDA registration
    GENTUITY, LLC·2 products·🇺🇸 United States

    GENTUITY, LLC

    FDA registration
    GENTUITY, LLC·3 products·🇺🇸 United States

    Vis-Rx

    FDA UDI
    GENTUITY LLC·00859910007018·1.8F Rapid exchange micro-imaging high frequenc...

    Vis-Rx Prime

    FDA UDI
    GENTUITY LLC·00859910007148·1.8F Rapid exchange micro-imaging high-frequenc...

    Gentuity HF-OCT Imaging System

    FDA UDI
    GENTUITY LLC·00859910007032·Gentuity OCT imaging console, including optical...

    Gentuity

    FDA UDI
    GENTUITY LLC·00859910007049·Gentuity Off-line Review Station includes compu...

    VIS-RX PRIME MICRO-IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·GENTUITY, LLC·Product code DQO·May 29, 2026

    G30-01 VIS-RX MICRO-IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·GENTUITY, LLC·Product code NQQ·May 26, 2026

    VIS-RX CATHETER

    FDA Adverse Event
    Malfunction ·GENTUITY, LLC·Product code DQO·May 29, 2026

    G31-01 VIS-RX PRIME MICRO-IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·GENTUITY, LLC·Product code DQO·May 22, 2026

    G10-01 GENTUITY HF-OCT IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·GENTUITY, LLC·Product code NQQ·May 19, 2026

    VIS-RX MICRO-IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·GENTUITY, LLC·Product code DQO·May 20, 2026

    VIS-RX MICRO-IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·GENTUITY, LLC·Product code DQO·May 21, 2026

    VIS-RX PRIME MICRO-IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·GENTUITY, LLC·Product code DQO·May 29, 2026

    VIS-RX MICRO-IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·GENTUITY, LLC·Product code DQO·May 27, 2026

    G10-01 GENTUITY HF-OCT IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·GENTUITY, LLC·Product code NQQ·April 2, 2026

    VIS-RX MICRO-IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·GENTUITY, LLC·Product code DQO·May 21, 2026

    G10-01 GENTUITY HF-OCT IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·GENTUITY, LLC·Product code NQQ·May 19, 2026

    G10-01 GENTUITY HF-OCT IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·GENTUITY, LLC·Product code NQQ·May 22, 2026