BEUDAMED
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    Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 21, 2017

    Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set consists of the following components: Flexor RTPS Guiding Sheath, needle, catheter, Dilator, Torcon NB Advantage Catheter, Van Andel Dilatation Catheter, Curved Newton Wire Guide, Amplatz Extra Stiff Wire Guide.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 29, 2015

    Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainless steel wire imbedded in the sheath shaft material with a soft tip and a Check-Flo¿ fitting at the proximal end. The sheath is accompanied by a dilator for access to the body as a catheter over the wire guide.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 29, 2015

    OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and coagulation

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 21, 2017

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015

    Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 6, 2019

    Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 12, 2019

    Thoracentesis Set, RPN C-THS-850, Order # G03286

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 12, 2019

    Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·February 27, 2019

    Rosen Curved Wire Guide

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 21, 2018

    Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·April 25, 2018

    1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·April 4, 2018

    Fixed Core Wire Guide

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 21, 2018

    Amplatz Extra Stiff Whisker Wire Guide

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 21, 2018

    Bentson Cerebral Wire Guide

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 21, 2018

    Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·February 21, 2018

    Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 12, 2019

    Bentson Plus Wire Guide

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 21, 2018

    Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 12, 2019

    Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 6, 2019