BEUDAMED
    187 results · 31ms · Sources: EU EUDAMED, US FDA

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    TARGIS SYSTEM

    FDA Adverse Event
    Injury ·UROLOGIX, INC.·Product code MEQ·May 16, 2013

    TARGIS

    FDA Adverse Event
    Injury ·UROLOGIX, INC.·Product code MEQ·August 30, 2006

    The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO, Manufactured for: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. UROLOGIX, CTC Advance Short, (2.5-3.5 cm), PT1034, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. CTC Advance Standard , (3.0-5.0 cm), PT1036, Sterile EO,, Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. CTC Advance Long, (4.5+ cm), PT1038, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. Targis Standard, (3.0-5.0 cm), PT1013, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. The Urologix Targis system is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH) and is indicated for men with prostatic urethral lengths greater than 2.5 cm.

    FDA Recall
    Terminated ·Urologix, Inc.·Product code MEQ·April 28, 2011

    UROLOGIX CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance" Long Microwave Catheter (4.5+ cm), CTC Advance" Short Microwave Catheter (2.5 -3.5 cm), RTU Plus Balloon, and RTU Plus Handle, Sterile EO, Manufactured by UROLOGIX, INC, 14405 Twenty-First Avenue North, Minneapolis, MN 55447. The CTC Advance" catheters and RTU Plus are used as part of the Targis System. Each disposable device is packaged on a card inside a heat sealed pouch. Each Kit Box then hold 3 product pouches: 1 catheter, 1 coolant bag and 1 RTU Plus balloon. The RTU Plus Kit contains 3 RTU Plus Handles packaged in separate sterile pouches.

    FDA Recall
    Terminated ·Urologix, Inc.·Product code MEQ·February 18, 2010

    TARGIS SYSTEM

    FDA Adverse Event
    Malfunction ·UROLOGIX, INC·Product code MEQ·May 12, 2014

    PROSTATRON

    FDA Adverse Event
    Malfunction ·UROLOGIX, INC.·Product code MEQ·January 5, 2004

    TARGIS

    FDA Adverse Event
    Injury ·UROLOGIX, INC.·Product code MEQ·March 18, 2004

    TARGIS SYSTEM

    FDA Adverse Event
    Injury ·UROLOGIX, INC.·Product code MEQ·February 4, 2010

    TARGIS SYSTEM

    FDA Adverse Event
    Injury ·UROLOGIX, INC.·Product code MEQ·February 4, 2010

    TARGIS SYSTEM

    FDA Adverse Event
    Injury ·UROLOGIX, INC.·Product code MEQ·March 30, 2010

    TARGIS SYSTEM

    FDA Adverse Event
    Injury ·UROLOGIX, INC.·Product code MEQ·February 2, 2010

    PROSTATRON SYSTEM

    FDA Adverse Event
    Injury ·UROLOGIX, INC.·Product code MEQ·February 23, 2010

    TARGIS SYSTEM

    FDA Adverse Event
    Injury ·UROLOGIX, INC.·Product code MEQ·January 11, 2010

    TARGIS SYSTEM

    FDA Adverse Event
    Injury ·UROLOGIX, INC.·Product code MEQ·June 17, 2010

    TARGIS SYSTEM

    FDA Adverse Event
    Injury ·UROLOGIX, INC.·Product code MEQ·April 28, 2010

    TARGIS SYSTEM

    FDA Adverse Event
    Malfunction ·UROLOGIX, INC.·Product code MEQ·April 9, 2010

    TARGIS SYSTEM

    FDA Adverse Event
    Injury ·UROLOGIX, INC.·Product code MEQ·April 29, 2010

    TARGIS SYSTEM

    FDA Adverse Event
    Injury ·UROLOGIX, INC.·Product code MEQ·May 18, 2010

    TARGIS

    FDA Adverse Event
    Other ·UROLOGIX, INC.·Product code MEQ·February 11, 2004

    PROSTATRON

    FDA Adverse Event
    Other ·UROLOGIX, INC.·Product code MEQ·January 14, 2004