This page includes the latest FDA filings for Cook Ireland L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Cook Ireland L T D holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3001845648 |
| FEI Number | 3001845648 |
| Name | April Lavender |
| Owner & Operator | COOK IRELAND LTD |
| Contact Address | O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK LIMERICK IE-LK Limerick 00000 IE |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 750 Daniels Way Bloomington, IN 47404 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
| Registration Number | 3009526575 |
| FEI Number | 3009526575 |
| Name | April Lavender |
| Owner & Operator | COOK IRELAND LTD |
| Contact Address | O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK LIMERICK IE-LK Limerick 00000 IE |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 750 Daniels Way Bloomington, IN 47404 US |
| Establishment Type | Export Device to the United States But Perform No Other Operation on Device |
Device Company | Device | Date |
|---|---|---|
| COOK IRELAND LTD | Geenen Sof-Flex GPSOS-SF-5-12 | 2025-12-22 |
| COOK IRELAND LTD | Geenen Sof-Flex GPSOS-SF-5-9 | 2025-12-22 |
| COOK IRELAND LTD | Geenen Sof-Flex GPSO-SF-5-12 | 2025-12-22 |
| COOK IRELAND LTD | Geenen Sof-Flex GPSO-SF-5-9 | 2025-12-22 |
| COOK IRELAND LTD | Geenen Sof-Flex GPSO-SF-5-7 | 2025-12-22 |
| COOK IRELAND LTD | Cotton-Leung Sof-Flex CLSO-SF-7-15 | 2025-12-22 |
| COOK IRELAND LTD | Cotton-Leung Sof-Flex CLSO-SF-7-12 | 2025-12-22 |
| COOK IRELAND LTD | Cotton-Leung Sof-Flex CLSO-SF-7-7 | 2025-12-22 |
| COOK IRELAND LTD | Cotton-Leung Sof-Flex CLSO-SF-7-5 | 2025-12-22 |
| COOK IRELAND LTD | Cotton-Leung Sof-Flex CLSO-SF-10-12 | 2025-12-22 |
| COOK IRELAND LTD | Cotton-Leung Sof-Flex CLSO-SF-10-9 | 2025-12-22 |
| COOK IRELAND LTD | Solus ZSS-10-1-RB | 2025-12-22 |
| COOK IRELAND LTD | Solus ZSS-10-10-RB | 2025-12-22 |
| COOK IRELAND LTD | Solus ZSS-10-15-RB | 2025-12-22 |
| COOK IRELAND LTD | Solus ZSS-10-12-RB | 2025-12-22 |
| COOK IRELAND LTD | Solus ZSS-10-9-RB | 2025-12-22 |
| COOK IRELAND LTD | Solus ZSS-10-7-RB | 2025-12-22 |
| COOK IRELAND LTD | Solus ZSS-10-5-RB | 2025-12-22 |
| COOK IRELAND LTD | Solus ZSS-10-4-RB | 2025-12-22 |
| COOK IRELAND LTD | Solus ZSS-10-3-RB | 2025-12-22 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-5-140 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-5-120 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-5-100 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-5-80 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-5-60 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-5-40 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-5-30 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-5-20 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-8-140 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-8-120 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-7-140 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-7-120 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-6-140 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-6-120 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-8-140 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-8-120 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-7-140 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-7-120 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-6-140 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-6-120 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-10-100 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-10-80 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-10-60 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-10-40 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-10-30 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-10-20 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-9-100 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-9-80 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-9-60 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-9-40 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-9-30 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-9-20 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-8-100 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-8-80 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-8-60 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-8-40 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-8-30 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-8-20 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-7-100 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-7-80 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-7-60 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-7-40 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-7-30 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-7-20 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-6-100 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-6-80 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-6-60 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-6-40 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-6-30 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-125-6-20 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-10-100 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-10-80 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-10-60 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-10-40 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-10-30 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-10-20 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-9-100 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-9-80 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-9-60 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-9-40 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-9-30 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-9-20 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-8-100 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-8-80 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-8-60 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-8-40 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-8-30 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-8-20 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-7-100 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-7-80 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-7-60 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-7-40 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-7-30 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-7-20 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-6-100 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-6-80 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-6-60 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-6-40 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-6-30 | 2025-12-12 |
| COOK IRELAND LTD | Zilver Flex ZFV6-35-80-6-20 | 2025-12-12 |
| Cook Ireland, Ltd. | Zilver® PTX® Drug-Eluting Peripheral Stent | 2022-02-02 |
| Cook Ireland, Ltd. | Zilver® PTX® Drug-Eluting Peripheral Stent | 2021-11-02 |
| Cook Ireland Ltd. | Zilver Vena Venous Self-Expanding Stent | 2021-10-26 |
| Cook Ireland Ltd. | Zilver Vena Venous Self-Expanding Stent | 2021-10-01 |
Cook Ireland Ltd. | 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 | 2021-05-20 |
| Cook Ireland, Ltd. | Zilver PTX Drug-Eluting Peripheral Stent | 2020-12-22 |
| Cook Ireland Ltd. | Zilver Vena Venous Self-Expanding Stent | 2020-10-09 |
| Cook Ireland, Ltd. | Zilver PTX Drug-Eluting Peripheral Stent | 2020-07-31 |
| Cook Ireland, Ltd. | Zilver PTX Drug-Eluting Peripheral Stent | 2020-05-15 |
April Lavender [COOK IRELAND LTD] | Marcon Colon Decompression Set | 2020-03-13 |
April Lavender [COOK IRELAND LTD] | Marcon Colon Decompression Set | 2020-03-13 |
April Lavender [COOK IRELAND LTD] | Colon Decompression Set | 2020-03-13 |
April Lavender [COOK IRELAND LTD] | Colon Decompression Set | 2020-03-13 |
April Lavender [COOK IRELAND LTD] | EchoTip Insight Portosystemic Pressure Gradient Measuring System | 2019-11-28 |
April Lavender [COOK IRELAND LTD] | EchoTip Insight Portosystemic Pressure Gradient Measuring System | 2019-11-28 |
Cook Ireland Ltd. | EchoTip Insight Portosystemic Pressure Gradient Measuring System | 2019-11-20 |
April Lavender [COOK IRELAND LTD] | Nasal Biliary Drainage Set | 2019-10-11 |
April Lavender [COOK IRELAND LTD] | Nasal Biliary Drainage Set | 2019-10-11 |
April Lavender [COOK IRELAND LTD] | Nagaraja Nasal Biliary Drainage Set | 2019-10-11 |
April Lavender [COOK IRELAND LTD] | Nagaraja Nasal Biliary Drainage Set | 2019-10-11 |
April Lavender [COOK IRELAND LTD] | Liguory Nasal Biliary Drainage Set | 2019-10-11 |
April Lavender [COOK IRELAND LTD] | Liguory Nasal Biliary Drainage Set | 2019-10-11 |
April Lavender [COOK IRELAND LTD] | Leung Nasal Biliary Drainage Set | 2019-10-11 |
April Lavender [COOK IRELAND LTD] | Leung Nasal Biliary Drainage Set | 2019-10-11 |
April Lavender [COOK IRELAND LTD] | Nasal Pancreatic Drainage Set | 2019-10-01 |
April Lavender [COOK IRELAND LTD] | Nasal Pancreatic Drainage Set | 2019-10-01 |
Cook Ireland Ltd | Zilver 518 Biliary Stent, Zilver 635 Biliary Stent | 2018-11-16 |
Cook Ireland Ltd. | Zimmon Pancreatic Stents/Stent Sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter And Guiding Catheter, Johlin Pancreatic Wedge Stent And Introducer Set | 2018-03-09 |
Cook Ireland Ltd | 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 Ac | 2018-02-27 |
Cook Ireland Ltd | 14Fr Colon Decompression Set, Macon Colon Decompression Set | 2017-08-01 |
Cook Ireland Ltd | Nasal Pancreatic Drainage Set | 2017-07-31 |
Cook Ireland Ltd. | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered | 2017-05-04 |
COOK IRELAND LTD | Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent | 2017-02-07 |
Cook Ireland Ltd. | Zilver 635 Biliary Stent | 2016-12-23 |
Cook Ireland Ltd. | Evolution Esophageal Stent System – Partially Covered | 2016-12-21 |
Cook Ireland Ltd. | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle | 2016-03-21 |
COOK IRELAND LTD | Echotip Procore HD Ultrasound Biopsy Needle | 2014-12-19 |
COOK IRELAND LTD | PLASMATRODE SALINE SAFE TUR ELECTRODE | 2013-04-17 |
COOK IRELAND LTD | EVOLUTION BILIARY STENT SYSTEM | 2013-03-01 |
COOK IRELAND LTD | EVOLUTION COLONIC STENT SYSTEM | 2012-05-17 |
COOK IRELAND LTD | INJEKT CYSTO FLEXIBLE INJECTION NEEDLE | 2012-02-14 |
COOK IRELAND LTD | EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D | 2011-03-29 |
COOK IRELAND LTD | EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E | 2010-06-17 |
COOK IRELAND LTD | ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O | 2010-01-21 |
COOK IRELAND LTD | ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A | 2009-11-02 |
COOK IRELAND LTD | RESONANCE METALLIC URETERAL STENT | 2007-05-08 |
COOK IRELAND LTD | SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE | 2006-09-06 |
COOK IRELAND LTD | MARATHON STENT WITH FUSION TECHNOLOGY | 2006-08-04 |
COOK IRELAND LTD | COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE | 2005-04-22 |
COOK IRELAND LTD | COOK IRELAND SONNET POLYPECTOMY SNARE | 2005-03-31 |
| NCAGE Code | SW232 | COOK IRELAND LTD |
| CAGE Code | SW232 | COOK IRELAND LTD |