BEUDAMED
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    MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code LQC·January 4, 2021

    MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code LQC·January 4, 2021

    MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·August 14, 2019

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·April 1, 2019

    Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEM·June 10, 2019

    Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FDT·January 28, 2021

    Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube model numbers: MAJ-13 and MAJ-15. To be used with Olympus endoscopes to electrosurgically resect tissue within the digestive tract.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code FDI·May 3, 2010

    Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·July 24, 2019

    Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·March 31, 2021

    MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 14, 2015

    MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEQ·September 11, 2015

    EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·June 8, 2016

    ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·May 1, 2013

    Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long, Wire: .035" DIA., 30 CM long, 3 MM J needle: 18 ga., 4.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLIP-7.0-35. Cook Inc., Bloomington, IN 47404

    FDA Recall
    Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

    Minipuncture Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 9 CM long, Wire: .025" DIA., 30 CM long, 3 MM J needle: 20XT GA., 4.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLIP-7.0-25-E-MNP. Cook Inc., Bloomington, IN 47404

    FDA Recall
    Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

    Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needles: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French, sterile, Catalog Number: C-PLI-7.0-35-X-1. Cook Inc., Bloomington, IN 47404

    FDA Recall
    Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

    Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French,sterile, Catalog Number: C-PLI-7.0-35. Cook Inc., Bloomington, IN 47404

    FDA Recall
    Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

    Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .038" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLI-7.0-38. Cook Inc., Bloomington, IN 47404

    FDA Recall
    Terminated ·Cook, Inc.·Product code DYB·December 7, 2007