Cook Ireland Ltd

FDA Filings

This page includes the latest FDA filings for Cook Ireland Ltd. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Cook Ireland Ltd
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent2018-11-16
Cook Ireland
Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set2018-07-06
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
COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE2005-04-22

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate
Cook Ireland Ltd.
EchoTip Insight Portosystemic Pressure Gradient Measuring System2019-11-20

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Echotip Insight
COOK IRELAND LTD2019-12-23
Geenen Sof-Flex
COOK IRELAND LTD2019-12-05
Geenen Sof-Flex
COOK IRELAND LTD2019-11-20
Geenen Sof-Flex
COOK IRELAND LTD2019-11-20
Geenen Sof-Flex
COOK IRELAND LTD2019-11-20
Geenen Sof-Flex
COOK IRELAND LTD2019-11-20
Cotton-Leung Sof-Flex
COOK IRELAND LTD2019-11-20
Cotton-Leung Sof-Flex
COOK IRELAND LTD2019-11-20
Cotton-Leung Sof-Flex
COOK IRELAND LTD2019-11-20
Cook
COOK IRELAND LTD2019-10-23
Cook
COOK IRELAND LTD2019-10-23
Liguory
COOK IRELAND LTD2019-10-22
Liguory
COOK IRELAND LTD2019-10-22
Liguory
COOK IRELAND LTD2019-10-22
Liguory
COOK IRELAND LTD2019-10-22
Liguory
COOK IRELAND LTD2019-10-22
Nagaraja
COOK IRELAND LTD2019-10-22
Cook
COOK IRELAND LTD2019-10-22
Liguory
COOK IRELAND LTD2019-10-22
Nagaraja
COOK IRELAND LTD2019-10-22
Cook
COOK IRELAND LTD2019-10-22
Cook
COOK IRELAND LTD2019-10-22
Cook
COOK IRELAND LTD2019-10-22
Nagaraja
COOK IRELAND LTD2019-10-22
Leung
COOK IRELAND LTD2019-10-22
Liguory
COOK IRELAND LTD2019-10-22
Leung
COOK IRELAND LTD2019-10-22
Cook
COOK IRELAND LTD2019-10-22
Nagaraja
COOK IRELAND LTD2019-10-22
Zilver 635
COOK IRELAND LTD2019-06-14
Zilver 635
COOK IRELAND LTD2019-05-30
Zilver 635
COOK IRELAND LTD2019-05-30
Zilver 635
COOK IRELAND LTD2019-04-18
Zilver 635
COOK IRELAND LTD2019-04-18
Zilver 635
COOK IRELAND LTD2019-04-18

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