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:

• E.J. Smith

FDA Registration(s)

• 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:
  • Aisling - O Sullivan
  • 353-61-334440-x
• US Agent:
  • April Lavender
  • Cook Incorporated
  • 812 3322235 2524
  • april.lavender@cookmedical.com
• 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:
  • Aisling - O Sullivan
  • 353-61-334440-x
• US Agent:
  • April Lavender
  • COOK, INC.
  • 812 3392235
  • 812 3320281
  • April.Lavender@CookMedical.com
• 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

FDA Filings

Device Company	Device	Date
GUDID 00827002597464 COOK IRELAND LTD	EchoTip AcuCore ECHO-BX-3-22	2023-10-11
GUDID 10827002307152 COOK IRELAND LTD	COOK DCB-SV-50	2023-02-24
GUDID 10827002307145 COOK IRELAND LTD	COOK DCB-DV-50	2023-02-24
GUDID 10827002306520 COOK IRELAND LTD	COOK DCB-D-50	2023-02-24
GUDID 10827002306513 COOK IRELAND LTD	COOK DCB-S-50	2023-02-24
GUDID 10827002482408 COOK IRELAND LTD	BIGopsy BLB-024115	2023-02-20
GUDID 10827002522272 COOK IRELAND LTD	Evolution EVO-FC-20-25-10-E	2022-11-28
GUDID 10827002522265 COOK IRELAND LTD	Evolution EVO-FC-20-25-12-E	2022-11-28
GUDID 10827002522258 COOK IRELAND LTD	Evolution EVO-FC-20-25-8-E	2022-11-28
GUDID 10827002511832 COOK IRELAND LTD	Evolution EVO-FC-18-23-12-E	2022-11-28
GUDID 10827002511825 COOK IRELAND LTD	Evolution EVO-FC-18-23-10-E	2022-11-28
GUDID 10827002511818 COOK IRELAND LTD	Evolution EVO-FC-18-23-8-E	2022-11-28
GUDID 10827002480336 COOK IRELAND LTD	Evolution EVO-20-25-15-E	2022-11-28
GUDID 10827002480329 COOK IRELAND LTD	Evolution EVO-20-25-12.5-E	2022-11-28
GUDID 10827002480312 COOK IRELAND LTD	Evolution EVO-20-25-10-E	2022-11-28
GUDID 10827002480305 COOK IRELAND LTD	Evolution EVO-20-25-8-E	2022-11-28
GUDID 00827002589902 COOK IRELAND LTD	Compass BDS CBBSO-7-15	2022-10-21
GUDID 00827002589896 COOK IRELAND LTD	Compass BDS CBBSO-7-10	2022-10-21
GUDID 00827002589889 COOK IRELAND LTD	Compass BDS CBBSO-7-5	2022-10-21
GUDID 10827002506241 COOK IRELAND LTD	Zilver 635 ZILBS-635-10-8	2022-04-08
GUDID 10827002506234 COOK IRELAND LTD	Zilver 635 ZILBS-635-8-8	2022-04-08
GUDID 10827002506227 COOK IRELAND LTD	Zilver 635 ZILBS-635-6-8	2022-04-08
GUDID 10827002506210 COOK IRELAND LTD	Zilver 635 ZILBS-635-10-6	2022-04-08
GUDID 10827002506203 COOK IRELAND LTD	Zilver 635 ZILBS-635-8-6	2022-04-08
GUDID 10827002506197 COOK IRELAND LTD	Zilver 635 ZILBS-635-6-6	2022-04-08
GUDID 10827002506180 COOK IRELAND LTD	Zilver 635 ZILBS-635-10-4	2022-04-08
GUDID 10827002506173 COOK IRELAND LTD	Zilver 635 ZILBS-635-8-4	2022-04-08
GUDID 10827002506166 COOK IRELAND LTD	Zilver 635 ZILBS-635-6-4	2022-04-08
GUDID 10827002362601 COOK IRELAND LTD	Zilver 518 ZIB5-80-5.0-80	2022-04-08
GUDID 10827002362595 COOK IRELAND LTD	Zilver 518 ZIB5-80-4.0-80	2022-04-08
GUDID 10827002362465 COOK IRELAND LTD	Zilver 635 ZIB6-125-14.0-80	2022-04-08
GUDID 10827002362458 COOK IRELAND LTD	Zilver 635 ZIB6-125-14.0-60	2022-04-08
GUDID 10827002362441 COOK IRELAND LTD	Zilver 635 ZIB6-125-14.0-40	2022-04-08
GUDID 10827002362434 COOK IRELAND LTD	Zilver 635 ZIB6-125-14.0-30	2022-04-08
GUDID 10827002362410 COOK IRELAND LTD	Zilver 635 ZIB6-125-12.0-80	2022-04-08
GUDID 10827002362403 COOK IRELAND LTD	Zilver 635 ZIB6-125-12.0-60	2022-04-08
GUDID 10827002362397 COOK IRELAND LTD	Zilver 635 ZIB6-125-12.0-40	2022-04-08
GUDID 10827002362380 COOK IRELAND LTD	Zilver 635 ZIB6-125-12.0-30	2022-04-08
GUDID 10827002362366 COOK IRELAND LTD	Zilver 635 ZIB6-80-14.0-80	2022-04-08
GUDID 10827002362359 COOK IRELAND LTD	Zilver 635 ZIB6-80-14.0-60	2022-04-08
GUDID 10827002362342 COOK IRELAND LTD	Zilver 635 ZIB6-80-14.0-40	2022-04-08
GUDID 10827002362335 COOK IRELAND LTD	Zilver 635 ZIB6-80-14.0-30	2022-04-08
GUDID 10827002362311 COOK IRELAND LTD	Zilver 635 ZIB6-80-12.0-80	2022-04-08
GUDID 10827002362304 COOK IRELAND LTD	Zilver 635 ZIB6-80-12.0-60	2022-04-08
GUDID 10827002362298 COOK IRELAND LTD	Zilver 635 ZIB6-80-12.0-40	2022-04-08
GUDID 10827002362281 COOK IRELAND LTD	Zilver 635 ZIB6-80-12.0-30	2022-04-08
GUDID 10827002360485 COOK IRELAND LTD	Zilver 518 ZIB5-125-5.0-80	2022-04-08
GUDID 10827002360478 COOK IRELAND LTD	Zilver 518 ZIB5-125-4.0-80	2022-04-08
GUDID 10827002360225 COOK IRELAND LTD	Zilver 635 ZIB6-125-5.0-80	2022-04-08
GUDID 10827002360218 COOK IRELAND LTD	Zilver 635 ZIB6-125-4.0-80	2022-04-08
GUDID 10827002360157 COOK IRELAND LTD	Zilver 635 ZIB6-80-5.0-80	2022-04-08
GUDID 10827002360140 COOK IRELAND LTD	Zilver 635 ZIB6-80-4.0-80	2022-04-08
GUDID 10827002320335 COOK IRELAND LTD	Zilver 635 ZIB6-125-5.0-60	2022-04-08
GUDID 10827002320328 COOK IRELAND LTD	Zilver 635 ZIB6-125-5.0-40	2022-04-08
GUDID 10827002320311 COOK IRELAND LTD	Zilver 635 ZIB6-125-5.0-30	2022-04-08
GUDID 10827002320304 COOK IRELAND LTD	Zilver 635 ZIB6-125-5.0-20	2022-04-08
GUDID 10827002320090 COOK IRELAND LTD	Zilver 635 ZIB6-80-5.0-60	2022-04-08
GUDID 10827002320083 COOK IRELAND LTD	Zilver 635 ZIB6-80-5.0-40	2022-04-08
GUDID 10827002320076 COOK IRELAND LTD	Zilver 635 ZIB6-80-5.0-30	2022-04-08
GUDID 10827002320014 COOK IRELAND LTD	Zilver 635 ZIB6-80-5.0-20	2022-04-08
GUDID 10827002314419 COOK IRELAND LTD	Zilver 518 ZIB5-125-4.0-60	2022-04-08
GUDID 10827002314396 COOK IRELAND LTD	Zilver 518 ZIB5-125-4.0-40	2022-04-08
GUDID 10827002314389 COOK IRELAND LTD	Zilver 518 ZIB5-125-4.0-30	2022-04-08
GUDID 10827002314372 COOK IRELAND LTD	Zilver 518 ZIB5-125-4.0-20	2022-04-08
GUDID 10827002313542 COOK IRELAND LTD	Zilver 518 ZIB5-125-5.0-60	2022-04-08
GUDID 10827002313528 COOK IRELAND LTD	Zilver 518 ZIB5-125-5.0-40	2022-04-08
GUDID 10827002313511 COOK IRELAND LTD	Zilver 518 ZIB5-125-5.0-30	2022-04-08
GUDID 10827002313504 COOK IRELAND LTD	Zilver 518 ZIB5-125-5.0-20	2022-04-08
GUDID 10827002238166 COOK IRELAND LTD	Zilver 635 ZILBS-635-10-12	2022-04-08
GUDID 10827002238159 COOK IRELAND LTD	Zilver 635 ZILBS-635-10-10	2022-04-08
GUDID 10827002238142 COOK IRELAND LTD	Zilver 635 ZILBS-635-8-12	2022-04-08
GUDID 10827002238135 COOK IRELAND LTD	Zilver 635 ZILBS-635-8-10	2022-04-08
GUDID 10827002238128 COOK IRELAND LTD	Zilver 635 ZILBS-635-6-12	2022-04-08
GUDID 10827002238111 COOK IRELAND LTD	Zilver 635 ZILBS-635-6-10	2022-04-08
GUDID 10827002231303 COOK IRELAND LTD	Evolution EVO-10-11-10-B	2022-04-08
GUDID 10827002231297 COOK IRELAND LTD	Evolution EVO-10-11-8-B	2022-04-08
GUDID 10827002231280 COOK IRELAND LTD	Evolution EVO-10-11-6-B	2022-04-08
GUDID 10827002231273 COOK IRELAND LTD	Evolution EVO-10-11-4-B	2022-04-08
GUDID 10827002231266 COOK IRELAND LTD	Evolution EVO-8-9-10-B	2022-04-08
GUDID 10827002231259 COOK IRELAND LTD	Evolution EVO-8-9-8-B	2022-04-08
GUDID 10827002231242 COOK IRELAND LTD	Evolution EVO-8-9-6-B	2022-04-08
GUDID 10827002231235 COOK IRELAND LTD	Evolution EVO-8-9-4-B	2022-04-08
PMA P100022S040 Cook Ireland, Ltd.	Zilver® PTX® Drug-Eluting Peripheral Stent	2022-02-02
PMA P100022S038 Cook Ireland, Ltd.	Zilver® PTX® Drug-Eluting Peripheral Stent	2021-11-02
PMA P200023S002 Cook Ireland Ltd.	Zilver Vena Venous Self-Expanding Stent	2021-10-26
PMA P200023S001 Cook Ireland Ltd.	Zilver Vena Venous Self-Expanding Stent	2021-10-01
GUDID 10827002268323 COOK IRELAND LTD	Johlin JPWS-8.5-22	2021-08-23
GUDID 10827002268316 COOK IRELAND LTD	Johlin JPWS-8.5-20	2021-08-23
GUDID 10827002268309 COOK IRELAND LTD	Johlin JPWS-8.5-18	2021-08-23
GUDID 10827002268286 COOK IRELAND LTD	Johlin JPWS-10-22	2021-08-23
GUDID 10827002268279 COOK IRELAND LTD	Johlin JPWS-10-20	2021-08-23
GUDID 10827002268255 COOK IRELAND LTD	Johlin JPWS-10-18	2021-08-23
GUDID 10827002257174 COOK IRELAND LTD	Johlin JPWS-10-16	2021-08-23
GUDID 10827002257167 COOK IRELAND LTD	Johlin JPWS-10-14	2021-08-23
GUDID 10827002257150 COOK IRELAND LTD	Johlin JPWS-10-12	2021-08-23
GUDID 10827002257143 COOK IRELAND LTD	Johlin JPWS-10-10	2021-08-23
GUDID 10827002257136 COOK IRELAND LTD	Johlin JPWS-10-8	2021-08-23
GUDID 10827002256955 COOK IRELAND LTD	Johlin JPWS-8.5-10	2021-08-23
GUDID 10827002256948 COOK IRELAND LTD	Johlin JPWS-8.5-8	2021-08-23
GUDID 10827002256931 COOK IRELAND LTD	Johlin JPWS-8.5-12	2021-08-23
GUDID 10827002256917 COOK IRELAND LTD	Johlin JPWS-8.5-14	2021-08-23
GUDID 10827002256900 COOK IRELAND LTD	Johlin JPWS-8.5-16	2021-08-23
PMN K210476 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
GUDID 10827002248899 COOK IRELAND LTD	Zilver PTX ZIV6-35-125-6-60-PTX	2021-02-05
GUDID 10827002248882 COOK IRELAND LTD	Zilver PTX ZIV6-35-125-6-40-PTX	2021-02-05
PMA P100022S037 Cook Ireland, Ltd.	Zilver PTX Drug-Eluting Peripheral Stent	2020-12-22
PMA P200023 Cook Ireland Ltd.	Zilver Vena Venous Self-Expanding Stent	2020-10-09
PMA P100022S036 Cook Ireland, Ltd.	Zilver PTX Drug-Eluting Peripheral Stent	2020-07-31
PMA P100022S035 Cook Ireland, Ltd.	Zilver PTX Drug-Eluting Peripheral Stent	2020-05-15
PMN K171619 | FEG April Lavender [COOK IRELAND LTD]	Marcon Colon Decompression Set	2020-03-13
PMN K171619 | FEG April Lavender [COOK IRELAND LTD]	Marcon Colon Decompression Set	2020-03-13
PMN K171619 | FEG April Lavender [COOK IRELAND LTD]	Colon Decompression Set	2020-03-13
PMN K171619 | FEG April Lavender [COOK IRELAND LTD]	Colon Decompression Set	2020-03-13
PMN DEN180062 | QIJ April Lavender [COOK IRELAND LTD]	EchoTip Insight Portosystemic Pressure Gradient Measuring System	2019-11-28
PMN DEN180062 | QIJ April Lavender [COOK IRELAND LTD]	EchoTip Insight Portosystemic Pressure Gradient Measuring System	2019-11-28
De Novo DEN180062 Cook Ireland Ltd.	EchoTip Insight Portosystemic Pressure Gradient Measuring System	2019-11-20
PMN K180868 | FGE April Lavender [COOK IRELAND LTD]	Nasal Biliary Drainage Set	2019-10-11
PMN K180868 | FGE April Lavender [COOK IRELAND LTD]	Nasal Biliary Drainage Set	2019-10-11
PMN K180868 | FGE April Lavender [COOK IRELAND LTD]	Nagaraja Nasal Biliary Drainage Set	2019-10-11
PMN K180868 | FGE April Lavender [COOK IRELAND LTD]	Nagaraja Nasal Biliary Drainage Set	2019-10-11
PMN K180868 | FGE April Lavender [COOK IRELAND LTD]	Liguory Nasal Biliary Drainage Set	2019-10-11
PMN K180868 | FGE April Lavender [COOK IRELAND LTD]	Liguory Nasal Biliary Drainage Set	2019-10-11
PMN K180868 | FGE April Lavender [COOK IRELAND LTD]	Leung Nasal Biliary Drainage Set	2019-10-11
PMN K180868 | FGE April Lavender [COOK IRELAND LTD]	Leung Nasal Biliary Drainage Set	2019-10-11
PMN K171623 | FGE April Lavender [COOK IRELAND LTD]	Nasal Pancreatic Drainage Set	2019-10-01
PMN K171623 | FGE April Lavender [COOK IRELAND LTD]	Nasal Pancreatic Drainage Set	2019-10-01
PMN K182980 Cook Ireland Ltd	Zilver 518 Biliary Stent, Zilver 635 Biliary Stent	2018-11-16
PMN K172057 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
PMN K172044 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
PMN K171619 Cook Ireland Ltd	14Fr Colon Decompression Set, Macon Colon Decompression Set	2017-08-01
PMN K171623 Cook Ireland Ltd	Nasal Pancreatic Drainage Set	2017-07-31
PMN K163468 Cook Ireland Ltd.	Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered	2017-05-04
PMN K163169 COOK IRELAND LTD	Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent	2017-02-07
PMN K163018 Cook Ireland Ltd.	Zilver 635 Biliary Stent	2016-12-23
PMN K162717 Cook Ireland Ltd.	Evolution Esophageal Stent System – Partially Covered	2016-12-21
PMN K160229 Cook Ireland Ltd.	Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle	2016-03-21
PMN K142688 COOK IRELAND LTD	Echotip Procore HD Ultrasound Biopsy Needle	2014-12-19
PMN K122716 COOK IRELAND LTD	PLASMATRODE SALINE SAFE TUR ELECTRODE	2013-04-17
PMN K121430 COOK IRELAND LTD	EVOLUTION BILIARY STENT SYSTEM	2013-03-01
PMN K113510 COOK IRELAND LTD	EVOLUTION COLONIC STENT SYSTEM	2012-05-17
PMN K113634 COOK IRELAND LTD	INJEKT CYSTO FLEXIBLE INJECTION NEEDLE	2012-02-14
PMN K101530 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
PMN K093619 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
PMN K093195 COOK IRELAND LTD	ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O	2010-01-21
PMN K092359 COOK IRELAND LTD	ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A	2009-11-02
PMN K063742 COOK IRELAND LTD	RESONANCE METALLIC URETERAL STENT	2007-05-08
PMN K060623 COOK IRELAND LTD	SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE	2006-09-06
PMN K060624 COOK IRELAND LTD	MARATHON STENT WITH FUSION TECHNOLOGY	2006-08-04
PMN K050578 COOK IRELAND LTD	COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE	2005-04-22
PMN K050294 COOK IRELAND LTD	COOK IRELAND SONNET POLYPECTOMY SNARE	2005-03-31

Similar & Related FDA Registered Companies

• Cook Ireland, Ltd.o'halloran Roadnational Technology Parklimerick  PMA NumberP050017 Supplement NumberS019 Date Received03/07/2022 Decision Date04/04/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	SW232	COOK IRELAND LTD
CAGE Code	SW232	COOK IRELAND LTD