BEUDAMED
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    UNK_LASSO

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DRF·July 1, 2019

    UNK_LASSO

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DRF·July 1, 2019

    UNK_LASSO

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DRF·July 1, 2019

    ULTREX

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FHW·August 27, 1997

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·September 10, 2021

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·May 31, 2021

    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 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

    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

    Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.

    FDA Recall
    Terminated ·Cardiac Science, Inc.·Product code MKJ·November 12, 2004

    Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.

    FDA Recall
    Terminated ·Cardiac Science, Inc.·Product code NPN·November 12, 2004

    Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·January 27, 2006

    Powerheart AED G3 Automated External Defibrillator Model 9300P Professional series). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.

    FDA Recall
    Terminated ·Cardiac Science, Inc.·Product code MKJ·November 12, 2004

    Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA.

    FDA Recall
    Terminated ·St. Jude Medical Daig Division·Product code MGB·August 22, 2005

    Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Single use. St. Jude medical, DAIG Division, Inc., Minnetonka, MN 55345-2126 USA

    FDA Recall
    Terminated ·St. Jude Medical Daig Division·Product code DYB·September 20, 2005

    OSMONICS 23G RO SYSTEM

    FDA Adverse Event
    Other ·OSMONICS, INC. / MINNETONKA OPERATIONS·Product code LIP·April 19, 2000

    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

    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

    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

    Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5850 Opus Parkway, Suite 300, Minnetonka, MN 55343. ( A web-based medical diagnostic tool that allows physicians to use PCs or notebook computers to gain remote access to 2D, 3D, and 4D advanced visualization. The software enables users to measure, rotate, and analyze images)

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·November 8, 2007