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Cook Ireland, Ltd.

US

Last updated May 27, 2026

What Cook Ireland, Ltd. makes

Cook Ireland, Ltd. manufactures a range of stents and drainage devices for biliary, pancreatic, and vascular applications, including non-bioabsorbable polymeric biliary and pancreatic stents, bare-metal biliary and peripheral venous stents, and peripheral artery stents. The company also produces endoscopic stent-placement systems, nasal biliary/pancreatic drainage catheters, and ultrasound aspiration biopsy procedure kits for diagnostic and therapeutic procedures.

The portfolio includes devices classified under FDA categories Class I, Class II, and Class III, with products listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
—
Website
cookmedical.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+1(812)330-5494
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
988559035

Catalogue (1093)

Page 22 of 22
DeviceModel / ReferenceRegistriesClassStatus
Zilver 635 G32006
FDA UDI
Class IIActive
Zimmon G21408
FDA UDI
Class IIActive
Soehendra Tannenbaum G22283
FDA UDI
Class IIActive
Zilver 635 G43819
FDA UDI
Class IIIActive
Zilver 635 G32001
FDA UDI
Class IIActive
Zimmon G24563
FDA UDI
Class IIActive
Cotton-Huibregtse G21801
FDA UDI
Class IIActive
Soehendra Tannenbaum G22127
FDA UDI
Class IIActive
EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) K241209
FDA 510(k)
Class IIActive
Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S K172044
FDA 510(k)
Class IIActive
Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered K163468
FDA 510(k)
Class IIActive
Evolution Esophageal Stent System – Partially Covered K162717
FDA 510(k)
Class IIActive
Plasmatrode Saline Safe Tur Electrode K122716
FDA 510(k)
Class IIActive
Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set K172057
FDA 510(k)
Class IIActive
Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-Hd-19a K092359
FDA 510(k)
Class IIActive
Marathon Stent With Fusion Technology K060624
FDA 510(k)
Class IIActive
Nasal Pancreatic Drainage Set K171623
FDA 510(k)
Class IIActive
Zilver 635 Biliary Stent K163018
FDA 510(k)
Class IIActive
Evolution Colonic Stent System K113510
FDA 510(k)
Class IIActive
Echotip Procore HD Ultrasound Biopsy Needle K142688
FDA 510(k)
Class IIActive
Evolution Esophageal Stent Fully Covered, Models Evo-Fc-18-23-8-E, Evo-Fc-18-23-10-E, Evo-Fc-18-23-12-E K093619
FDA 510(k)
Class IIActive
Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent K163169
FDA 510(k)
Class IIActive
Cook Ireland Duette Multi-Band Mucosectomy Device K050578
FDA 510(k)
Class IIActive
Evolution Esophageal Stent System K080359
FDA 510(k)
Class IIActive
Shortshot Saeed Hemorrhoidal Multi-Band Ligator With Triview Anoscope K060623
FDA 510(k)
Class IIActive
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent K182980
FDA 510(k)
Class IIActive
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) K230909
FDA 510(k)
Class IIActive
Cook Ireland Sonnet Polypectomy Snare K050294
FDA 510(k)
Class IIActive
Compass BDS Biliary Stent K213946
FDA 510(k)
Class IIActive
Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D, Evp-22-27-12-D K101530
FDA 510(k)
Class IIActive
Cook Ireland Echobrush K052279
FDA 510(k)
Class IIActive
Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF) K233079
FDA 510(k)
Class IIActive
Injekt Cysto Flexible Injection Needle K113634
FDA 510(k)
Class IIActive
EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle K210476
FDA 510(k)
Class IIActive
Evolution Biliary Stent System K121430
FDA 510(k)
Class IIActive
Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-Hd-22-Ebus-O K093195
FDA 510(k)
Class IIActive
Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle K160229
FDA 510(k)
Class IIActive
14Fr Colon Decompression Set, Macon Colon Decompression Set K171619
FDA 510(k)
Class IIActive
Resonance Metallic Ureteral Stent K063742
FDA 510(k)
Class IIActive
EchoTip Insight Portosystemic Pressure Gradient Measuring System DEN180062
FDA 510(k)
Class IIActive
Zilver Vena Venous Self-Expanding Stent P200023
FDA PMA
Class IIIActive
Zilver Ptx Drug-Eluting Peripheral Stent P100022
FDA PMA
Class IIIActive
Zilver® Vascular Stent P050017
FDA PMA
Class IIIActive

Related Companies

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Cook Ireland Limited IE