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

    Peel-Away Introducer set, Catheter introducer, sterile; Catalog Number: C-PLI-7.0-38-CPC-072491. William Cook Europe A/S, Cook Inc., Bloomington, IN 47404.

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

    Cook Urological Endoureterotomy Stent, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCF-060026-10-13; GPN REF G18131. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/24 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060024-10-13; GPN REF G18132. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/24 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070024-14-13; GPN REF G18125. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070026-14-13; GPN REF G18127. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/20 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070020-14-13; GPN REF G18123. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/30 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060030-10-13; GPN REF G18121. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/22 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070022-14-13; GPN REF G18133. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/18 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070018-14-13; GPN REF G18641. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/30 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070030-14-13; GPN REF G18130. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/18 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060018-10-13; GPN REF G18116. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/28 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060028-10-13; GPN REF G18120. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060026-10-13; GPN REF G18119. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/22 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060022-10-13; GPN REF G18118. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/20 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060020-10-13; GPN REF G18117. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008

    Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/28 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070028-14-13; GPN REF G18134. Ureteral stent. Ureteral stent.

    FDA Recall
    Terminated ·Vance Products Incorporated·Product code FAD·July 31, 2008