Cook Ireland, Ltd.

PMA#

• Zilver Vascular Stent

  2022-04-04

  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 Pro...

• 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.

• 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

  Cook Ireland, Ltd.

PMN#

• EchoTip AcuCore? EUS Biopsy Needle (ECHO-BX-19)

  2024-07-29

  Cook Ireland, Ltd.

• 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);

  2024-06-14

  Cook Ireland, Ltd.

• EchoTip® AcuCore? Ultrasound Biopsy Needle (ECHO-BX-3-22)

  2023-05-30

  Cook Ireland, Ltd.

• Compass BDS Biliary Stent

  2022-05-09

  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 518 Biliary Stent, Zilver 635 Biliary Stent

  2018-11-16

  Cook Ireland Ltd

• Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set

  2018-07-06

  Cook Ireland

• 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

• EVOLUTION ESOPHAGEAL STENT SYSTEM

  2008-05-09

  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

  COOK IRELAND LTD

GUDID#

• EchoTip - Echotip Ultra, Endoscopic Ultrasound Needle

  COOK IRELAND LTD

  2016-09-24

• EchoTip - Echotip Ultra, Endoscopic Ultrasound Needle

  COOK IRELAND LTD

  2016-09-24

• EchoTip - Echotip Ultra, Endoscopic Ultrasound Needle

  COOK IRELAND LTD

  2016-09-24

• EchoTip ProCore - Echotip Procore, HD Ultrasound Biopsy Needle

  COOK IRELAND LTD

  2016-09-24

• EchoTip ProCore - Echotip Procore, HD Ultrasound Biopsy Needle

  COOK IRELAND LTD

  2016-09-24

• EchoTip ProCore - Echotip Procore, HD Ultrasound Biopsy Needle

  COOK IRELAND LTD

  2016-09-24

• EchoTip ProCore - Echotip Procore, HD Ultrasound Biopsy Needle

  COOK IRELAND LTD

  2016-09-24

• Fusion Marathon - Fusion Marathon, Anti-Reflux Biliary Stent

  COOK IRELAND LTD

  2015-10-24

• Johlin - Johlin, Pancreatic Wedge Stent and Introducer

  COOK IRELAND LTD

  2015-10-24

• Johlin - Johlin, Pancreatic Wedge Stent and Introducer

  COOK IRELAND LTD

  2015-10-24

• Johlin - Johlin, Pancreatic Wedge Stent and Introducer

  COOK IRELAND LTD

  2015-10-24

• Johlin - Johlin, Pancreatic Wedge Stent and Introducer

  COOK IRELAND LTD

  2015-10-24

• Johlin - Johlin, Pancreatic Wedge Stent and Introducer

  COOK IRELAND LTD

  2015-10-24

• Johlin - Johlin, Pancreatic Wedge Stent and Introducer

  COOK IRELAND LTD

  2015-10-24

• Zimmon - Zimmon, Biliary Stent Set

  COOK IRELAND LTD

  2015-10-24

• Zimmon - Zimmon, Biliary Stent Set

  COOK IRELAND LTD

  2015-10-24

• Zimmon - Zimmon, Biliary Stent Set

  COOK IRELAND LTD

  2015-10-24

• Zimmon - Zimmon, Biliary Stent Set

  COOK IRELAND LTD

  2015-10-24

• Zimmon - Zimmon, Biliary Stent Set

  COOK IRELAND LTD

  2015-10-24

• Geenen Sof-Flex - Geenen Sof-Flex Pancreatic Stent

  COOK IRELAND LTD

  2015-11-03

• Geenen Sof-Flex - Geenen Sof-Flex Pancreatic Stent

  COOK IRELAND LTD

  2015-11-03

• Geenen Sof-Flex - Geenen Sof-Flex Pancreatic Stent

  COOK IRELAND LTD

  2015-11-03

• Geenen Sof-Flex - Geenen Sof-Flex Pancreatic Stent

  COOK IRELAND LTD

  2015-11-03

• Geenen Sof-Flex - Geenen Sof-Flex Pancreatic Stent

  COOK IRELAND LTD

  2015-11-03

• Johlin - Johlin, Pancreatic Wedge Stent and introducer

  COOK IRELAND LTD

  2015-10-24

• Johlin - Johlin, Pancreatic Wedge Stent and Introducer

  COOK IRELAND LTD

  2015-10-24

• Johlin - Johlin, Pancreatic Wedge Stent and Introducer

  COOK IRELAND LTD

  2015-10-24

• Johlin - Johlin, Pancreatic Wedge Stent and Introducer

  COOK IRELAND LTD

  2015-10-24

• Geenen Sof-Flex - Geenen Sof-Flex Pancreatic Stent

  COOK IRELAND LTD

  2015-11-03

• Geenen Sof-Flex - Geenen Sof-Flex Pancreatic Stent

  COOK IRELAND LTD

  2015-11-03

• Geenen Sof-Flex - Geenen Sof-Flex Pancreatic Stent

  COOK IRELAND LTD

  2015-11-03

• Geenen Sof-Flex - Geenen Sof-Flex Pancreatic Stent

  COOK IRELAND LTD

  2015-11-03

• Geenen Sof-Flex - Geenen Sof-Flex Pancreatic Stent

  COOK IRELAND LTD

  2015-11-03

• Solus - Solus, Double Pigtail Stent with Introducer

  COOK IRELAND LTD

  2015-10-24

• Solus - Solus, Double Pigtail Stent with Introducer

  COOK IRELAND LTD

  2015-10-24

• Solus - Solus, Double Pigtail Stent with Introducer

  COOK IRELAND LTD

  2015-10-24

• Solus - Solus, Double Pigtail Stent with Introducer

  COOK IRELAND LTD

  2015-10-24

• Solus - Solus, Double Pigtail Stent with Introducer

  COOK IRELAND LTD

  2015-10-24

• Solus - Solus, Double Pigtail Stent with Introducer

  COOK IRELAND LTD

  2015-10-24

• Solus - Solus, Double Pigtail Stent with Introducer

  COOK IRELAND LTD

  2015-10-24

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