| EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes (K261274) | Cook Ireland, Ltd. | 2026-07-24 |
| EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) (K241209) | Cook Ireland, Ltd. | 2024-07-29 |
| 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) | Cook Ireland, Ltd. | 2024-06-14 |
| EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (K230909) | Cook Ireland, Ltd. | 2023-05-30 |
| Compass BDS Biliary Stent (K213946) | Cook Ireland, Ltd. | 2022-05-09 |
| 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) | Cook Ireland, Ltd. | 2021-05-20 |
| EchoTip Insight Portosystemic Pressure Gradient Measuring System (DEN180062) | Cook Ireland, Ltd. | 2019-11-20 |
| Zilver 518 Biliary Stent, Zilver 635 Biliary Stent (K182980) | Cook Ireland, Ltd. | 2018-11-16 |
| Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set (K172057) | Cook Ireland, Ltd. | 2018-03-09 |
| 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) | Cook Ireland, Ltd. | 2018-02-27 |
| 14Fr Colon Decompression Set, Macon Colon Decompression Set (K171619) | Cook Ireland, Ltd. | 2017-08-01 |
| Nasal Pancreatic Drainage Set (K171623) | Cook Ireland, Ltd. | 2017-07-31 |
| Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered (K163468) | Cook Ireland, Ltd. | 2017-05-04 |
| Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent (K163169) | Cook Ireland, Ltd. | 2017-02-07 |
| Zilver 635 Biliary Stent (K163018) | Cook Ireland, Ltd. | 2016-12-23 |
| Evolution Esophageal Stent System – Partially Covered (K162717) | Cook Ireland, Ltd. | 2016-12-21 |
| Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle (K160229) | Cook Ireland, Ltd. | 2016-03-21 |
| Echotip Procore HD Ultrasound Biopsy Needle (K142688) | Cook Ireland, Ltd. | 2014-12-19 |
| PLASMATRODE SALINE SAFE TUR ELECTRODE (K122716) | Cook Ireland, Ltd. | 2013-04-17 |
| EVOLUTION BILIARY STENT SYSTEM (K121430) | Cook Ireland, Ltd. | 2013-03-01 |
| EVOLUTION COLONIC STENT SYSTEM (K113510) | Cook Ireland, Ltd. | 2012-05-17 |
| INJEKT CYSTO FLEXIBLE INJECTION NEEDLE (K113634) | Cook Ireland, Ltd. | 2012-02-14 |
| EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D (K101530) | Cook Ireland, Ltd. | 2011-03-29 |
| 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) | Cook Ireland, Ltd. | 2010-06-17 |
| ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O (K093195) | Cook Ireland, Ltd. | 2010-01-21 |
| ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A (K092359) | Cook Ireland, Ltd. | 2009-11-02 |
| EVOLUTION ESOPHAGEAL STENT SYSTEM (K080359) | Cook Ireland, Ltd. | 2008-05-09 |
| RESONANCE METALLIC URETERAL STENT (K063742) | Cook Ireland, Ltd. | 2007-05-08 |
| SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE (K060623) | Cook Ireland, Ltd. | 2006-09-06 |
| MARATHON STENT WITH FUSION TECHNOLOGY (K060624) | Cook Ireland, Ltd. | 2006-08-04 |
| COOK IRELAND ECHOBRUSH (K052279) | Cook Ireland, Ltd. | 2005-10-11 |
| COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE (K050578) | Cook Ireland, Ltd. | 2005-04-22 |
| COOK IRELAND SONNET POLYPECTOMY SNARE (K050294) | Cook Ireland, Ltd. | 2005-03-31 |