BEUDAMED
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    APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Channel Size: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc·Product code FGE·July 25, 2003

    BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMI·May 31, 2017

    BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·December 13, 2017

    SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

    FDA Enforcement
    Class II ·Terminated·Akita Sumitomo Bakelite Co., Ltd.·November 16, 2016

    SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

    FDA Enforcement
    Class II ·Terminated·Akita Sumitomo Bakelite Co., Ltd.·November 16, 2016

    EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit the jaws of the instrument. PN 410322-05

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·March 4, 2015

    EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·October 22, 2014

    EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·March 4, 2015

    Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Medivators, Inc.·April 29, 2020

    ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBB·April 25, 2013

    Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek Usa, Inc Dallas Distribution·Product code HBB·April 8, 2016

    Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

    Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotomy applications.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek Usa, Inc Dallas Distribution·Product code HBB·November 30, 2009

    Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137.

    FDA Recall
    Terminated ·Medtronic Powered Surgical Solutions·Product code HBB·June 29, 2005

    Anspach Single Use, Sterile Bone Cutting Burrs

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBB·May 18, 2007

    DYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog Number: 7205336 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code HAB·May 6, 2011

    Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

    Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

    Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)

    FDA Recall
    Terminated ·Medtronics Midas Rex·Product code HBB·November 11, 2002

    Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 Medtronic Powered Surgical Solutions, Forth Worth, TX Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Surgery applications for transection, osteotomy, graft harvesting, bone shaping, laminectomy, entry hole, suture hole, and midface advancement.

    FDA Recall
    Terminated ·Medtronic Powered Surgical Solutions·Product code HBB·May 30, 2008