BEUDAMED
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    Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.

    FDA Enforcement
    Class I ·Terminated·Endologix Inc·June 19, 2013

    AFX

    FDA Adverse Event
    Injury ·ENDOLOGIX INC.·Product code MIH·May 16, 2018

    AFX

    FDA Adverse Event
    Injury ·ENDOLOGIX INC.·Product code MIH·May 9, 2018

    Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.

    FDA Recall
    Terminated ·Endologix Inc·Product code DYB·May 13, 2013

    AFX

    FDA Adverse Event
    Injury ·ENDOLOGIX INC.·Product code MIH·April 23, 2018

    AFX

    FDA Adverse Event
    Injury ·ENDOLOGIX INC.·Product code MIH·May 9, 2018

    AFX

    FDA Adverse Event
    Injury ·ENDOLOGIX INC.·Product code MIH·May 9, 2018

    AFX

    FDA Adverse Event
    Injury ·ENDOLOGIX INC.·Product code MIH·May 16, 2018

    ALTO

    FDA Adverse Event
    Death ·ENDOLOGIX SANTA ROSA·Product code MIH·June 3, 2021

    OVATION

    FDA Adverse Event
    Injury ·ENDOLOGIX SANTA ROSA·Product code MIH·April 16, 2026

    OVATION

    FDA Adverse Event
    Malfunction ·ENDOLOGIX SANTA ROSA·Product code MIH·April 16, 2026

    AFX

    FDA Adverse Event
    Injury ·ENDOLOGIX INC.·Product code MIH·May 15, 2018

    AFX

    FDA Adverse Event
    Injury ·ENDOLOGIX INC.·Product code MIH·May 16, 2018

    AFX

    FDA Adverse Event
    Injury ·ENDOLOGIX INC.·Product code MIH·May 9, 2018

    AFX

    FDA Adverse Event
    Injury ·ENDOLOGIX·Product code MIH·July 27, 2021

    ALTO

    FDA Adverse Event
    Injury ·ENDOLOGIX SANTA ROSA·Product code MIH·July 9, 2021

    AFX2

    FDA Adverse Event
    Death ·ENDOLOGIX·Product code MIH·March 15, 2021

    OVATION IX

    FDA Adverse Event
    Injury ·ENDOLOGIX SANTA ROSA·Product code MIH·February 14, 2022

    AFX2

    FDA Adverse Event
    Injury ·ENDOLOGIX·Product code MIH·November 14, 2023

    ALTO

    FDA Adverse Event
    Injury ·ENDOLOGIX SANTA ROSA·Product code MIH·July 9, 2024