BEUDAMED
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    Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·February 10, 2016

    Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Olympus America, Inc.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code LQC·September 20, 2007

    Olympus Single Use Mechanical Lithotriptor, Model number BML-V232QR-30, Olympus America, Inc.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code LQC·September 20, 2007

    Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26, Olympus America, Inc.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code LQC·September 20, 2007

    Olympus Single Use Mechanical Lithotriptor, Model number BML-V242QR-30, Olympus America, Inc.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code LQC·September 20, 2007

    Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FDT·January 8, 2016

    OLA 2500 Olympus Lab Automation Systems to include the following models (all serial numbers): S2 Full Size, S3 Full Size, Standard Full Size and High Speed Full Size (Aliquoter) manufactured by Olympus Life and Material Science Europa GmbH, Germany and distributed by Olympus America, Inc., 3131 W. Royal Ln., Irving, TX 75063.

    FDA Recall
    Terminated ·Olympus America, Inc·Product code JQP·November 18, 2005

    Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt.

    FDA Recall
    Terminated ·Olympus America Inc. Two·Product code LMB·March 5, 2003

    Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irrigation & Aspiration Pump; 10 sets per box; Manufactured for: Olympus America Inc., Two Corporate Center Drive, Melville, NY 11747-3157; catalog #72-00114-0 The fluid aspiration set is used in conjunction with the Olympus SP-2 pump for fluid aspiration during urological endoscopic procedures or laparoscopic procedures.

    FDA Recall
    Terminated ·Northgate Technologies, Inc.·Product code KQT·July 25, 2011

    Olympus Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagulation electrosurgical devices intended for use in electrosurgery procedures during flexible gastrointestinal endoscopy.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code GEI·November 28, 2011

    OLYMPUS Pediatric Knives and Resection Electrodes The pediatric knives are intended for use in urethrotomy in pediatric applications. The HF resection electrodes are intended for use in transurethral resection in pediatric applications.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code EZO·December 22, 2010

    Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22066A and WA22067A. Working element for endoscopic diagnosis and treatment in urological and gynecological applications.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code KNS·December 27, 2011

    Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and WA22367A. Working element for cutting, coagulation, and vaporization in conductive irrigation fluid or conductive distension medium in the Saline mode.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code KNS·December 27, 2011

    Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes (fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation), light sources and other ancillary equipment.

    FDA Enforcement
    Class II ·Terminated·Olympus America Inc.·May 15, 2013

    Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Olympus America Inc.·November 27, 2013

    TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.

    FDA Enforcement
    Class II ·Terminated·Olympus America Inc.·December 11, 2013

    EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    FDA Enforcement
    Class II ·Terminated·Olympus America Inc.·September 30, 2015

    Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes (fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation), light sources and other ancillary equipment.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code KNS·November 10, 2009

    Olympus Mobile Workstations (Endoscopy Carts), Models WM-DP1, WM-NP1 and WM-WP1 The mobile workstations are intended for use in medical facilities under the direction of a trained physician, and has been designed to be used with a range of Olympus equipment to facilitate GI endoscopy, endoscopic ultrasound, respiratory and surgical endoscopic

    FDA Recall
    Terminated ·Olympus America Inc.·Product code FEM·October 28, 2011

    Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment)

    FDA Recall
    Terminated ·Olympus America Inc.·Product code GCJ·August 20, 2010