BEUDAMED
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    Genius AI Detection 2.0 with CC-MLO Correlation

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERTECOR MIDLLINE OSTEOTOME 3.0

    FDA Adverse Event
    Malfunction ·DFINE INC.·Product code GFI·January 9, 2015

    VERTECOR MIDLINE OSTEOTOME

    FDA Adverse Event
    Malfunction ·DFINE INC.·Product code GFI·March 5, 2015

    HOLOGIC SELENIA MAMMOGRAPHY EQUIPMENT

    FDA Adverse Event
    Malfunction ·HOLOGIC IN·Product code MUE·August 8, 2023

    VERTECOR MIDLINE CEMENT SAGING OSTEOTOME

    FDA Adverse Event
    Malfunction ·DFINE INC.·Product code GFI·July 31, 2015

    CONTOUR MAMMOGRAPHY SYS

    FDA Adverse Event
    Other ·TREX MEDICAL CORP., BENNETT DIV.·Product code IZH·September 15, 1998

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC.·Product code MUE·August 15, 2022

    HFX-PLUS

    FDA Adverse Event
    Malfunction ·FISCHER IMAGING CORP·Product code IZO·June 6, 2002

    3DIMENSIONS

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC·Product code OTE·November 15, 2021

    VERTECOR MIDLINE CEMENT STAGING OSTEOTOME

    FDA Adverse Event
    Malfunction ·DFINE INC.·Product code GFI·August 31, 2015

    SELENIA MAMMOGRAPHY SYSTEM

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC·Product code MUE·September 11, 2018

    SELENIA® DIMENSIONS® 3D¿ PERFORMANCE

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC·Product code OTE·June 17, 2024

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 2D

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC·Product code MUE·December 28, 2022

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC·Product code OTE·May 7, 2019

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 2D

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC·Product code MUE·October 31, 2022

    VERTECOR MIDLINE CEMENT STAGING OSTEOTOME

    FDA Adverse Event
    Malfunction ·DFINE INC.·Product code GFI·July 31, 2015

    SENOGRAPHE 2000D

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS S.C.S.·Product code MUE·December 4, 2009

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC·Product code OTE·March 5, 2019

    ALLERGAN NATRELLE SILICONE 20-800 SILICONE BREAST IMPLOANT L & R

    FDA Adverse Event
    Injury ·ALLERGAN·Product code FTR·July 26, 2019

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·January 3, 2019