431 results · 21ms · Sources: EU EUDAMED, US FDA

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COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·April 15, 2026

COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·April 15, 2026

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

Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

FDA Enforcement
Class II ·Ongoing·Alcon Research LLC·August 28, 2024

Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

FDA Enforcement
Class II ·Ongoing·Alcon Research LLC·August 28, 2024

Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

FDA Enforcement
Class II ·Ongoing·Alcon Research LLC·August 28, 2024

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 Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·January 22, 2025

Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.

FDA Enforcement
Class II ·Ongoing·Wilson-Cook Medical Inc.·December 11, 2024

Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·January 22, 2025

Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·January 22, 2025

COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·April 15, 2026

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 Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·April 15, 2026

COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·April 15, 2026