BEUDAMED
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    Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·December 21, 2016

    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

    Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.

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

    Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 18, 2015

    UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 30, 2016

    Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral strictures or ureteral dilation prior to ureteroscopy and stone manipulation.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 30, 2016

    Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages

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

    COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S

    FDA Enforcement
    Class II ·Terminated·Wilson-Cook Medical Inc.·February 6, 2019

    COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S

    FDA Enforcement
    Class II ·Terminated·Wilson-Cook Medical Inc.·February 6, 2019

    Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 20, 2019

    Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 7, 2018

    Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 7, 2018

    Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 7, 2018

    Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·May 29, 2019

    Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·September 23, 2020

    Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 14, 2017

    Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 14, 2017

    LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 14, 2017

    Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 14, 2017

    Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;

    FDA Enforcement
    Class III ·Terminated·Cook Medical Incorporated·April 13, 2022