BEUDAMED
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    CARDIOFOCUS, INC.

    FDA registration
    CARDIOFOCUS, INC.·4 products·🇺🇸 United States

    HeartLight

    FDA UDI
    CARDIOFOCUS, INC.·00868976000161·Endoscopic Ablation Console (JP)

    HeartLight

    FDA UDI
    CARDIOFOCUS, INC.·00868976000123·Endoscope

    HeartLight

    FDA UDI
    CARDIOFOCUS, INC.·00859373007433·HeartLight X3 Disposable Motor Catheter

    HeartLight

    FDA UDI
    CARDIOFOCUS, INC.·00859373007464·HeartLight X3 Console, EU

    HeartLight

    FDA UDI
    CARDIOFOCUS, INC.·00868976000109·Laser Ablation Balloon Catheter

    HeartLight

    FDA UDI
    CARDIOFOCUS, INC.·00859373007440·HeartLight X3 Console, US

    HeartLight

    FDA UDI
    CARDIOFOCUS, INC.·00868976000154·Laser Ablation Console

    HeartLight

    FDA UDI
    CARDIOFOCUS, INC.·00859373007495·HeartLight X3 Console, JP

    HeartLight

    FDA UDI
    CARDIOFOCUS, INC.·00868976000147·Deflectable Sheath

    HeartLight

    FDA UDI
    CARDIOFOCUS, INC.·00868976000116·Endoscopic Ablation Console (EU)

    HeartLight

    FDA UDI
    CARDIOFOCUS, INC.·00868976000178·Endoscopic Ablation Catheter

    HeartLight

    FDA UDI
    CARDIOFOCUS, INC.·00868976000130·Balloon Fill Media

    VIZIGO SHEATH

    FDA Adverse Event
    Injury ·CARDIOFOCUS, INC.·Product code DYB·August 12, 2023

    UNK_SMART TOUCH BIDIRECTIONAL SF

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·July 7, 2023

    HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM

    FDA Adverse Event
    Injury ·CARDIOFOCUS, INC.·Product code OAE·September 5, 2023

    HEATLIGHT LASER BALLOON

    FDA Adverse Event
    Injury ·CARDIOFOCUS, INC.·Product code OAE·August 9, 2023

    HEARTLIGHT

    FDA Adverse Event
    Malfunction ·CARDIOFOCUS, INC·Product code OAE·January 5, 2023

    LIGHTSTIC 360 DIFFUSER

    FDA Adverse Event
    Malfunction ·RARE EARTH MEDICAL INC·Product code LQJ·August 26, 2002

    THERMOCOOL SMARTTOUCH

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·January 9, 2025