Cook Ireland L T D

FDA Filings

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:

FDA Registration(s)
Registration Number3001845648
FEI Number3001845648
NameApril Lavender
Owner & OperatorCOOK IRELAND LTD
Contact AddressO'HALLORAN ROAD NATIONAL TECHNOLOGY PARK
LIMERICK IE-LK Limerick 00000 IE
Official Correspondent
  • Aisling - O Sullivan
  • 353-61-334440-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address750 Daniels Way
Bloomington, IN 47404 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



Registration Number3009526575
FEI Number3009526575
NameApril Lavender
Owner & OperatorCOOK IRELAND LTD
Contact AddressO'HALLORAN ROAD NATIONAL TECHNOLOGY PARK
LIMERICK IE-LK Limerick 00000 IE
Official Correspondent
  • Aisling - O Sullivan
  • 353-61-334440-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address750 Daniels Way
Bloomington, IN 47404 US
Establishment TypeExport Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
Cook Ireland, Ltd.
Zilver PTX Drug-Eluting Peripheral Stent2020-05-15
COOK IRELAND LTD
Marcon CDSM-102020-03-24
COOK IRELAND LTD
Cook CDSG-14-1752020-03-24
COOK IRELAND LTD
Marcon CDSM-72020-03-24
COOK IRELAND LTD
Marcon CDSM-8.52020-03-24
April Lavender [COOK IRELAND LTD]
Marcon Colon Decompression Set2020-03-13
April Lavender [COOK IRELAND LTD]
Marcon Colon Decompression Set2020-03-13
April Lavender [COOK IRELAND LTD]
Colon Decompression Set2020-03-13
April Lavender [COOK IRELAND LTD]
Colon Decompression Set2020-03-13
COOK IRELAND LTD
Echotip Insight ECHO-PPG2019-12-23
COOK IRELAND LTD
Geenen Sof-Flex GPSO-SF-5-32019-12-05
April Lavender [COOK IRELAND LTD]
EchoTip Insight Portosystemic Pressure Gradient Measuring System2019-11-28
April Lavender [COOK IRELAND LTD]
EchoTip Insight Portosystemic Pressure Gradient Measuring System2019-11-28
COOK IRELAND LTD
Geenen Sof-Flex GPSOS-SF-5-72019-11-20
COOK IRELAND LTD
Geenen Sof-Flex GPSOS-SF-5-52019-11-20
COOK IRELAND LTD
Geenen Sof-Flex GPSOS-SF-5-32019-11-20
COOK IRELAND LTD
Geenen Sof-Flex GPSO-SF-5-52019-11-20
COOK IRELAND LTD
Cotton-Leung Sof-Flex CLSO-SF-7-92019-11-20
COOK IRELAND LTD
Cotton-Leung Sof-Flex CLSO-SF-10-152019-11-20
COOK IRELAND LTD
Cotton-Leung Sof-Flex CLSO-SF-10-72019-11-20
Cook Ireland Ltd.
EchoTip Insight Portosystemic Pressure Gradient Measuring System2019-11-20
COOK IRELAND LTD
Cook NPDS-72019-10-23
COOK IRELAND LTD
Cook NPDS-52019-10-23
COOK IRELAND LTD
Liguory ENBD-6-LIGUORY-RT2019-10-22
COOK IRELAND LTD
Liguory ENBD-7-LIGUORY-RT2019-10-22
COOK IRELAND LTD
Liguory ENBD-5-LIGUORY-RT2019-10-22
COOK IRELAND LTD
Liguory ENBD-8.5-LIGUORY2019-10-22
COOK IRELAND LTD
Liguory ENBD-5-LIGUORY2019-10-22
COOK IRELAND LTD
Nagaraja ENBD-5-NAG2019-10-22
COOK IRELAND LTD
Cook ENBD-102019-10-22
COOK IRELAND LTD
Liguory ENBD-6-LIGUORY2019-10-22
COOK IRELAND LTD
Nagaraja ENBD-7-NAG2019-10-22
COOK IRELAND LTD
Cook ENBD-72019-10-22
COOK IRELAND LTD
Cook ENBD-62019-10-22
COOK IRELAND LTD
Cook ENBD-52019-10-22
COOK IRELAND LTD
Nagaraja ENBD-8.5-NAG2019-10-22
COOK IRELAND LTD
Leung ENBD-6.5-LEUNG-72019-10-22
COOK IRELAND LTD
Liguory ENBD-7-LIGUORY2019-10-22
COOK IRELAND LTD
Leung ENBD-6.5-LEUNG-42019-10-22
COOK IRELAND LTD
Cook ENBD-8.52019-10-22
COOK IRELAND LTD
Nagaraja ENBD-6-NAG2019-10-22
April Lavender [COOK IRELAND LTD]
Nasal Biliary Drainage Set2019-10-11
April Lavender [COOK IRELAND LTD]
Nasal Biliary Drainage Set2019-10-11
April Lavender [COOK IRELAND LTD]
Nagaraja Nasal Biliary Drainage Set2019-10-11
April Lavender [COOK IRELAND LTD]
Nagaraja Nasal Biliary Drainage Set2019-10-11
April Lavender [COOK IRELAND LTD]
Liguory Nasal Biliary Drainage Set2019-10-11
April Lavender [COOK IRELAND LTD]
Liguory Nasal Biliary Drainage Set2019-10-11
April Lavender [COOK IRELAND LTD]
Leung Nasal Biliary Drainage Set2019-10-11
April Lavender [COOK IRELAND LTD]
Leung Nasal Biliary Drainage Set2019-10-11
April Lavender [COOK IRELAND LTD]
Nasal Pancreatic Drainage Set2019-10-01
April Lavender [COOK IRELAND LTD]
Nasal Pancreatic Drainage Set2019-10-01
COOK IRELAND LTD
Zilver 635 ZIB6-40-12.0-402019-06-14
COOK IRELAND LTD
Zilver 635 ZIB6-40-12.0-802019-05-30
COOK IRELAND LTD
Zilver 635 ZIB6-40-12.0-602019-05-30
COOK IRELAND LTD
Zilver 635 ZIB6-40-10.0-802019-04-18
COOK IRELAND LTD
Zilver 635 ZIB6-40-8.0-802019-04-18
COOK IRELAND LTD
Zilver 635 ZIB6-40-6.0-802019-04-18
COOK IRELAND LTD
Zilver 635 ZIB6-40-10.0-602019-04-18
COOK IRELAND LTD
Zilver 635 ZIB6-40-10.0-402019-04-18
COOK IRELAND LTD
Zilver 635 ZIB6-40-8.0-602019-04-18
COOK IRELAND LTD
Zilver 635 ZIB6-40-8.0-402019-04-18
COOK IRELAND LTD
Zilver 635 ZIB6-40-6.0-602019-04-18
COOK IRELAND LTD
Zilver 635 ZIB6-40-6.0-402019-04-18
COOK IRELAND LTD
Cystotome CST-102019-02-21
Cook Ireland Ltd
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent2018-11-16
COOK IRELAND LTD
Geenen GEPD-7-42018-03-29
COOK IRELAND LTD
Geenen GEPD-7-32018-03-29
COOK IRELAND LTD
Cotton-Leung CLSO-10-92018-03-29
COOK IRELAND LTD
Cotton-Leung CLSO-10-82018-03-29
COOK IRELAND LTD
Cotton-Leung CLSO-10-72018-03-29
COOK IRELAND LTD
Cotton-Leung CLSO-10-62018-03-29
COOK IRELAND LTD
Cotton-Leung CLSO-10-42018-03-29
COOK IRELAND LTD
Cotton-Leung CLSO-10-32018-03-29
COOK IRELAND LTD
Cotton-Leung CLSO-10-22018-03-29
COOK IRELAND LTD
Zimmon ZEBD-8-72018-03-29
COOK IRELAND LTD
Zimmon ZEBD-8-52018-03-29
COOK IRELAND LTD
Cotton-Huibregtse CHBS-10-92018-03-29
COOK IRELAND LTD
Liguory ENBD-7-LIGUORY-C2018-03-29
COOK IRELAND LTD
Cotton-Huibregtse CHBS-10-72018-03-29
COOK IRELAND LTD
Cotton-Huibregtse CHBS-10-52018-03-29
COOK IRELAND LTD
Cotton-Huibregtse CHBS-10-32018-03-29
COOK IRELAND LTD
Huibregtse 2018-03-29
COOK IRELAND LTD
Zimmon ZEBD-11.5-92018-03-29
COOK IRELAND LTD
Cook 2018-03-29
COOK IRELAND LTD
Zimmon ZEBD-11.5-72018-03-29
COOK IRELAND LTD
Soehendra Tannenbaum TTSO-10-92018-03-29
COOK IRELAND LTD
Soehendra Tannenbaum TTSO-10-82018-03-29
COOK IRELAND LTD
Zimmon ZEBD-11.5-52018-03-29
COOK IRELAND LTD
Soehendra Tannenbaum TTSO-10-72018-03-29
COOK IRELAND LTD
Soehendra Tannenbaum TTSO-10-62018-03-29
COOK IRELAND LTD
Soehendra Tannenbaum TTSO-10-52018-03-29
COOK IRELAND LTD
Zimmon ZEPDF-7-92018-03-29
COOK IRELAND LTD
Zimmon ZEPDF-7-82018-03-29
COOK IRELAND LTD
Zimmon ZEPDF-7-62018-03-29
COOK IRELAND LTD
Zimmon ZEPDF-7-42018-03-29
COOK IRELAND LTD
Zimmon ZEPDF-7-22018-03-29
COOK IRELAND LTD
Cook ENBD-7-C2018-03-29
COOK IRELAND LTD
Zimmon ZPSOS-5-122018-03-29
COOK IRELAND LTD
Zimmon ZSO-8-152018-03-29
COOK IRELAND LTD
Zimmon ZSO-8-122018-03-29
COOK IRELAND LTD
Zimmon ZSO-8-102018-03-29
COOK IRELAND LTD
Zimmon ZEBD-7-92018-03-29
COOK IRELAND LTD
Zimmon ZEBD-7-82018-03-29
COOK IRELAND LTD
Zimmon ZEBD-7-72018-03-29
COOK IRELAND LTD
Zimmon ZEBD-7-62018-03-29
COOK IRELAND LTD
Zimmon ZEBD-7-52018-03-29
COOK IRELAND LTD
Zimmon ZEBD-7-42018-03-29
COOK IRELAND LTD
Oasis OA-11.52018-03-29
COOK IRELAND LTD
Geenen GPSO-7-92018-03-29
COOK IRELAND LTD
Geenen GPSO-7-72018-03-29
COOK IRELAND LTD
Geenen GPSO-7-62018-03-29
COOK IRELAND LTD
Zimmon ZSO-8-92018-03-29
COOK IRELAND LTD
Geenen GPSO-7-52018-03-29
COOK IRELAND LTD
Geenen GPSO-7-42018-03-29
COOK IRELAND LTD
Zimmon ZSO-8-72018-03-29
COOK IRELAND LTD
Geenen GPSO-7-32018-03-29
COOK IRELAND LTD
Zimmon ZSO-8-52018-03-29
COOK IRELAND LTD
Zimmon ZSO-8-42018-03-29
COOK IRELAND LTD
Cook ENBD-6-C2018-03-29
Cook Ireland Ltd.
Zimmon Pancreatic Stents/Stent Sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter And Guiding Catheter, Johlin Pancreatic Wedge Stent And Introducer Set2018-03-09
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 Ac2018-02-27
Cook Ireland Ltd
14Fr Colon Decompression Set, Macon Colon Decompression Set2017-08-01
Cook Ireland Ltd
Nasal Pancreatic Drainage Set2017-07-31
Cook Ireland Ltd.
Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered2017-05-04
COOK IRELAND LTD
Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent2017-02-07
Cook Ireland Ltd.
Zilver 635 Biliary Stent2016-12-23
Cook Ireland Ltd.
Evolution Esophageal Stent System – Partially Covered2016-12-21
Cook Ireland Ltd.
Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle2016-03-21
COOK IRELAND LTD
Echotip Procore HD Ultrasound Biopsy Needle2014-12-19
COOK IRELAND LTD
PLASMATRODE SALINE SAFE TUR ELECTRODE2013-04-17
COOK IRELAND LTD
EVOLUTION BILIARY STENT SYSTEM2013-03-01
COOK IRELAND LTD
EVOLUTION COLONIC STENT SYSTEM2012-05-17
COOK IRELAND LTD
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE2012-02-14
COOK IRELAND LTD
EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D2011-03-29
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-E2010-06-17
COOK IRELAND LTD
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O2010-01-21
COOK IRELAND LTD
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A2009-11-02
COOK IRELAND LTD
RESONANCE METALLIC URETERAL STENT2007-05-08
COOK IRELAND LTD
SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE2006-09-06
COOK IRELAND LTD
MARATHON STENT WITH FUSION TECHNOLOGY2006-08-04
COOK IRELAND LTD
COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE2005-04-22
COOK IRELAND LTD
COOK IRELAND SONNET POLYPECTOMY SNARE2005-03-31

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