Cook Incorporated

FDA Filings

This page includes the latest FDA filings for Cook Incorporated. 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 Incorporated
UPJ Occlusion Balloon Catheter2019-08-05
Cook Incorporated
Roadrunner PC Wire Guide, Olcott Torque Device2019-07-22
Cook Incorporated
Kaye Nephrostomy Tamponade Balloon Catheter And Stent Set2019-07-16
Cook Incorporated
Deflectable Brush Biopsy Set2019-06-26
Cook Incorporated
Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set2019-06-26
Cook Incorporated
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter2019-06-17
Cook Incorporated
Peel-Away Introducer2019-05-29
Cook Incorporated
Brush Biopsy Set ; Deflectable Brush Biopsy Set2019-05-01
Cook Incorporated
Multi-Sideport Catheter Infusion Set2019-04-25
Cook Incorporated
Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set2019-04-23
Cook Incorporated
Park Blade Septostomy Catheter2019-04-04
Cook Incorporated
Intrauterine Access Balloon Catheter, Selective Salpingography Catheter2019-03-29
Cook Incorporated
Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set2019-03-27
Cook Incorporated
Polyethylene Catheter2019-03-22
Cook Incorporated
Lunderquist® Fixed Core Wire Guide2019-02-15
Cook Incorporated
One-Step Suprapubic Introducer2018-12-26
Cook Incorporated
Dilator Sets2018-12-20
Cook Incorporated
Reuter Tip Deflecting Wire Guide2018-12-20
Cook Incorporated
Arterial Pressure Monitoring Set/Tray2018-12-19
Cook Incorporated
Arterial Pressure Monitoring Set/Tray2018-11-30
Cook Incorporated
Greene Renal Transplant Stent Set2018-11-23
Cook Ireland Ltd
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent2018-11-16
Cook Incorporated
Günther Tulip® Vena Cava Filter Retrieval Set2018-11-06
Cook Incorporated
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set2018-10-30
Cook Incorporated
Cook Silicone Balloon HSG Catheter2018-10-26
Cook Incorporated
Margolin HSG Cannula, Goldstein Sonohysterography Catheter2018-10-26
Cook Incorporated
Polyethylene Catheter2018-10-26
Cook Incorporated
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter2018-10-24
Cook Incorporated
Royal Flush Plus High-Flow Catheter2018-10-05
Cook Incorporated
Seidmon Antegrade AQ Stent Set2018-09-28

Latest Premarket Applications

PMAManufacturerDevice NameDate
COOK MEDICAL INCORPORATED
Zilver PTX Drug-Eluting Peripheral Stent2019-09-13
COOK MEDICAL INCORPORATED
Zilver PTX Drug-Eluting Peripheral Stent2019-03-26
Cook Incorporated
Zilver Vascular Stent2019-03-21
COOK MEDICAL INCORPORATED
Zilver PTX Drug-Eluting Peripheral Stent2018-12-20
COOK MEDICAL INCORPORATED
Zilver PTX Drug-Eluting Peripheral Stent2018-11-08
COOK, INC.
ZENITH FLEX AAA ENDOVASCULAR GRAFT2018-10-10
COOK MEDICAL INCORPORATED
Zilver PTX Drug-Eluting Peripheral Stent2018-09-10
COOK MEDICAL INCORPORATED
ZILVER PTX Drug-Eluting Peripheral Stent.2018-08-29
COOK MEDICAL INCORPORATED
Zilver PTX Drug-Eluting Peripheral Stent2018-08-23
COOK, INC.
Zenith AAA Endovascular Graft2018-07-20
Cook Incorporated
Zilver Vascular Stent2018-06-26
COOK MEDICAL INCORPORATED
Zilver PTX Drug-Eluting Peripheral Stent2018-01-11
COOK MEDICAL INCORPORATED
Zilver PTX Drug-Eluting Peripheral Stent2017-06-15
COOK MEDICAL INCORPORATED
Zilver PTX Drug-Eluting Peripheral Stent2017-05-02
COOK MEDICAL INCORPORATED
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT2017-04-11
COOK MEDICAL INCORPORATED
Zilver PTX Drug-Eluting Peripheral Stent2017-04-06
Cook Incorporated
Zilver Vascular Stent2017-04-06
COOK MEDICAL INCORPORATED
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT2016-12-28
COOK MEDICAL INCORPORATED
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT2016-12-16
Cook Incorporated
ZILVER VASCULAR STENT2016-12-16
COOK, INC.
ZENITH AAA ENDOVASCULAR GRAFT2016-12-08
Cook Incorporated
ZILVER VASCULAR STENT2016-07-01
COOK MEDICAL INCORPORATED
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT2016-07-01
COOK, INC.
ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM2016-06-03
COOK MEDICAL INCORPORATED
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT2016-04-14
COOK MEDICAL INCORPORATED
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT2016-01-06
COOK MEDICAL INCORPORATED
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT2015-10-26
Cook Incorporated
ZILVER VASCULAR STENT2015-08-31
COOK MEDICAL INCORPORATED
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT2015-08-13
Cook Incorporated
ZILVER VASCULAR STENT2015-08-13

Latest De Novo Filings

De NovoManufacturerDevice NameDate
Cook Incorporated
Retrograde Intubation Set2018-12-12

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Desilets-Hoffman
COOK INCORPORATED2019-11-27
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
Lehman
COOK INCORPORATED2019-11-08
Lehman
COOK INCORPORATED2019-11-08
Cook
COOK INCORPORATED2019-11-08
Glo-Tip
COOK INCORPORATED2019-11-07
Captura
COOK INCORPORATED2019-10-31
Ultraxx
COOK INCORPORATED2019-10-29
Ultraxx
COOK INCORPORATED2019-10-29
Ultraxx
COOK INCORPORATED2019-10-29
Ultraxx
COOK INCORPORATED2019-10-29
Ultraxx
COOK INCORPORATED2019-10-29
Ultraxx
COOK INCORPORATED2019-10-29
Cook
COOK INCORPORATED2019-10-29
Cook
COOK INCORPORATED2019-10-29
Cook
COOK INCORPORATED2019-10-29
Cook
COOK INCORPORATED2019-10-29
Cook
COOK INCORPORATED2019-10-29
Cook
COOK INCORPORATED2019-10-29
Vital-Port
COOK INCORPORATED2019-10-23
Vital-Port
COOK INCORPORATED2019-10-23
Vital-Port
COOK INCORPORATED2019-10-23
Vital-Port
COOK INCORPORATED2019-10-23
Vital-Port
COOK INCORPORATED2019-10-23
Vital-Port
COOK INCORPORATED2019-10-23
Vital-Port
COOK INCORPORATED2019-10-23
Vital-Port
COOK INCORPORATED2019-10-23
Vital-Port
COOK INCORPORATED2019-10-23
Vital-Port
COOK INCORPORATED2019-10-23

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