431 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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