BEUDAMED
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    AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only ), Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343 InhibiZone Antibiotic Surface Treatment, AMS 800 Urinary Control Pump with InhibiZone, REF 72404127, Sterilization Method ETO, American Medical Systems Inc., 10700 Bren West, Minnetonka, MN 55343 The AMS Urinary Control System (of which the pump is a component) is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery.

    FDA Recall
    Terminated ·American Medical Systems, Inc.·Product code EZY·May 9, 2011

    Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·May 4, 2016

    American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134

    FDA Recall
    Terminated ·AMS Innovative Center San Jose·Product code GEX·June 18, 2007

    AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN

    FDA Recall
    Terminated ·American Medical Systems·Product code FAE·February 19, 2007

    AMS Acticon Neosphincter Pump, Product Number 72402287, Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343. The Acticon Neosphincter is an implantable device used to treat severe fecal incontinence in males and females eighteen years and older who have failed, or are not candidates for less invasive forms of restorative therapy.

    FDA Recall
    Terminated ·American Medical Systems, Inc.·Product code MIP·May 9, 2011

    AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minnetonka, MN

    FDA Recall
    Terminated ·American Medical Systems·Product code FAE·February 19, 2007

    GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by American Medical Systems Inc., San Jose, CA The XPS Laser system is indicated for surgical incision and excision, vaporization, ablation, hemostasis and coagulation of soft tissue.

    FDA Recall
    Terminated ·AMS Innovative Center San Jose·Product code GEX·July 14, 2010

    Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems, Inc. A diagnostic ultrasound system.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IYN·October 1, 2010

    Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc., Tusin, CA.

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code ITX·December 19, 2006

    Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male Sling System, INTL; Model # 72404224: Male TO Sling System, INTL. Sterilization Method ETO, American Medical systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA

    FDA Recall
    Terminated ·American Medical Systems, Inc.·Product code FTL·September 7, 2010

    Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·October 25, 2016

    her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The Her Option Cryoablation Therapy System consists of a Console, a Cryoprobe and a Disposable Probe.

    FDA Recall
    Terminated ·American Medical Systems·Product code MNB·January 13, 2006

    Aquilion One: Aquilion TSX-301B, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A multislice CT system that supports whole-body scanning.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·January 7, 2011

    Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A multislice CT system that supports whole-body scanning.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·January 7, 2011

    AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.

    FDA Enforcement
    Class II ·Terminated·American Medical Systems, Inc.·May 22, 2013

    AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800 Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.

    FDA Recall
    Terminated ·American Medical Systems, Inc.·Product code EZY·March 1, 2013

    AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800 Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.

    FDA Recall
    Terminated ·American Medical Systems, Inc.·Product code EZY·March 1, 2013

    AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen LP is a sterile non-perforated processed porcine collagen dermal matrix. Sterile EO. American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The AMS collagen dermal matric is intended for use in the treatment of hernias where connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, or gastroenterological anatomy.

    FDA Recall
    Terminated ·American Medical Systems·Product code FTM·December 5, 2008

    Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·November 14, 2012

    Elevate System with IntePro Lite", Anterior and Apical Prolapse Repair System, REF720093-01, Sterile EO, Manufactured by:American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA Product Usage: The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenteriological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair. As configured, the Elevate Anterior device is used solely for prolapse repair

    FDA Recall
    Terminated ·American Medical Systems, Inc.·Product code FTL·May 9, 2011