BEUDAMED
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    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM

    FDA Adverse Event
    Malfunction ·HOLOGIC INC·Product code MUE·October 8, 2025

    ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO VILLALBA·Product code OAE·December 10, 2025

    TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code OAE·November 25, 2025

    QDOT MICRO

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code OAE·November 24, 2025

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE D

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code OAE·December 5, 2025

    ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·October 31, 2025

    ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO VILLALBA·Product code OAE·December 8, 2025

    ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·November 12, 2025

    QDOT MICRO CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code OAE·December 29, 2025

    ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO VILLALBA·Product code OAE·November 6, 2025

    QDOT MICRO

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC·Product code OAE·December 24, 2025

    QDOT MICRO

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code OAE·November 3, 2025

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code OAE·December 8, 2025

    QDOT MICRO

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code OAE·November 14, 2025

    DIAMONDTEMP¿

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code OAE·October 15, 2025

    TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code OAE·November 19, 2025

    DIAMONDTEMP¿

    FDA Adverse Event
    Injury ·EPIX THERAPEUTICS·Product code OAE·December 17, 2025

    EPICEL

    FDA Adverse Event
    Injury ·VERICEL·Product code OCE·November 6, 2025

    TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code OAE·October 27, 2025

    QDOT MICRO

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code OAE·August 27, 2025