This page includes the latest FDA filings for Cook Medical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Cook Medical holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3007965706 |
| FEI Number | 3007965706 |
| Name | Cook Medical LLC |
| Owner & Operator | COOK MEDICAL |
| Contact Address | 400 DANIELS WAY -- Bloomington IN 47404 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1025 Acuff Road Bloomington, IN 47404 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
| Registration Number | 3005580113 |
| FEI Number | 3005580113 |
| Name | COOK MEDICAL LLC |
| Owner & Operator | COOK MEDICAL |
| Contact Address | 400 DANIELS WAY -- Bloomington IN 47404 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 400 DANIELS WAY Bloomington, IN 47404 US |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
Device Company | Device | Date |
|---|---|---|
Cook Medical LLC [COOK MEDICAL] | Colon Decompression Set | 2020-03-13 |
Cook Medical LLC [COOK MEDICAL] | EchoTip Ingight Portosystemic Pressure Gradient Measurement System | 2019-12-06 |
Cook Medical LLC [COOK MEDICAL] | Nasal Biliary Drainage Set | 2019-10-31 |
Cook Medical LLC [COOK MEDICAL] | Nagaraja Nasal Biliary Drainage Set | 2019-10-31 |
Cook Medical LLC [COOK MEDICAL] | Liguory Nasal Biliary Drainage Set | 2019-10-31 |
Cook Medical LLC [COOK MEDICAL] | Leung Nasal Biliary Drainage Set | 2019-10-31 |
Cook Medical LLC [COOK MEDICAL] | Nasal Pancreatic Drainage Set | 2019-10-31 |
Cook Medical LLC [COOK MEDICAL] | Towako Transmyometrial Embryo Transfer Set | 2019-09-04 |
Cook Medical LLC [COOK MEDICAL] | Disposable Endoscopic Cleaning Brush | 2019-07-26 |
Cook Medical LLC [COOK MEDICAL] | Disposable Endoscopic Cleaning Brush Set | 2019-07-26 |
Cook Medical LLC [COOK MEDICAL] | Nathanson Liver Retractor System | 2019-07-26 |
Cook Medical LLC [COOK MEDICAL] | Murdoch Mechanical Arm | 2019-07-26 |
Cook Medical LLC [COOK MEDICAL] | BIGopsy? Backloading Biopsy Forceps | 2019-07-26 |
Cook Medical LLC [COOK MEDICAL] | BIGopsy ng forceps | 2019-07-26 |
Cook Medical LLC [COOK MEDICAL] | Zenith? TX2? Dissection Endovascular Graft with Pro-Form? and the Z-Trak? Plus Introduction System-Straight Component | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zenith? TX2? Dissection Endovascular Graft with Pro-Form? and the Z-Trak? Plus Introduction System -Tapered Component | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zenith? Dissection Endovascular Stent with the Z-Trak? Plus Introduction System | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zenith Alpha? Thoracic Endovascular Graft ? Proximal Tapered Component | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zenith Alpha? Thoracic Endovascular Graft ? Proximal Component | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zenith Alpha? Thoracic Endovascular Graft ? Distal Extension | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zenith Alpha? Thoracic Endovascular Graft ? Distal Component | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | FormulaTM 414 RX Renal Ballon-Expandable Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zilver? PTX? Drug-Eluting Peripheral Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zilver? PTX? Drug Eluting Peripheral Stent SET | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zilver 635? Vascular Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zilver 635 Vascular Self-Expanding Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zilver 518? Vascular Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zilver 518 Vascular Self-Expanding Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zenith Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent) | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | COOK Ultra Quiet Vacuum Pump & Regulator | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Johlin Pancreatic Wedge Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | COOK Mini-Incubator | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | COOK Test Tube Heater | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Transmyometrial Embryo Transfer Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Ovum Pick-up Aspiration Needle | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zimmon? Pancreatic Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zimmon? Pancreatic Stent Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Pancreatic Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Greenen Sofflex | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Geenen? Pancreatic Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Geenen? Pancreatic Stent Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Marcon Colon Decompression Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Colon Decompression Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Nasal Biliary Drainage Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Nasal Biliary Drainage Catheter | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Nagaraja Nasal Biliary Drainage Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Nagaraja Nasal Biliary Drainage Catheter | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Liguory Nasal Biliary Drainage Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Liguory Nasal Biliary Drainage Set Radiopaque Tip | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Liguory Nasal Biliary Drainage Catheter | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Leung Nasal Biliary Drainage Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Leung Nasal Biliary Drainage Catheter | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zimmon? Biliary Stent Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zimmon(R) Biliary stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Stent Introducer Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Solus(R) Double Pigtail Stent with Introducer | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Solus Biliary Stent and Introducer Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | ST-2 Soehendra? Tannenbaum? Biliary Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Pushing Catheter | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Oasis? Stent Introduction System | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Oasis? One Action Stent Introduction System | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Oasis? One Action Stent Introduction System with Pre-Loaded ST-2 Tannenbaum? Biliary Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Oasis-one action stent introduction system? with Pre-loaded Cotton-Leung? Biliary Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Oasis-One Action Stent Introduction system(R) | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Huibregtse-Katon Pusher | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Huibregtse Guiding Catheter | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Guiding Catheter | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Cotton-Leung? Biliary Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Cotton-Leung? (Amsterdam) Biliary Stent Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Cotton-Leung Biliary Stent Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Cotton-Huibregtse? Biliary Stent Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Cotton-Huibregtse(R) Biliary Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Cotton Leung | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zilver 635? Biliary Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zilver 518? Biliary Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zilver 518 Biliary Self-Expanding Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Cook Celect Platinum Vena Cava Filter set for Jugular Vein Appraoch | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Single Lumen Ovum Aspiration Needle | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Double Lumen Ovum Aspiration Needle | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Lunderquist? Extra Stiff Wire Guide | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | DC Wire Guides | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Culture Oil | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Evolution? Duodenal Stent System- Uncovered | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Evolution? Duodenal Controlled-Release Stent - Uncovered | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Evolution? Duodenal Stent System- Uncovered | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Evolution? Duodenal Controlled-Release Stent - Uncovered | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zilver 635 Biliary Self Expanding Metal Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Evolution? Esophageal Stent System-Partially Covered | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Frova Intubating introducer | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Sperm Cryopreservation Buffer | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | COOK Vacuum Pump | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Echotip Procore? Endobronchial HD Ultrasound Biopsy Needle for Olympus Scopes | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | EchoTip? Ultra Endobronchial High Definition Ultrasound Needle | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Gamete Buffer | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Egg/Embryo Solutions | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Embryo Biopsy Medium | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Sperm Solutions | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Blastocyst Thawing Kit | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Blastocyst Cryopreservation Kit | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Thawing Kit | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Cryopreservation Kit | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF PVP | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Egg/Embryo Solutions | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Flipper? Detachable Embolization Coils | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Flipper? 35 Closure Detachable Coil Delivery System | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | COOK Sydney IVF Blastocyst Warming Kit | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | COOK Sydney IVF Blastocyst Vitrification Kit | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | ECHOTIP PROCORE? HD ULTRASOUND BIOPSY NEEDLE | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Otrieva Tapered Ovum Aspiration Needle | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Evolution? Biliary Stent System Uncovered | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Evolution? Biliary Controlled-Release Stent - Uncovered | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Evolution? Esophageal Stent System- Fully Covered | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Evolution? Esophageal Controlled-Release Stent -Fully Covered | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | EchoTip? Ultra High Definition Ultrasound Access Needle | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | EchoTip? Ultra Endoscopic Ultrasound Needle | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | COOK Sydney IVF Blastocyst Warming Kit | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | COOK Sydney IVF Blastocyst Vitrification Kit | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Resonance? Stent Introducer | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Resonance? Metallic Ureteral Stent and Introducer | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Resonance Stent Set | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Resonance Positioner | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Sperm Cryopreservation Buffer | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Fusion? Marathon? Anti-Reflux Biliary Stent | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | ShortShot? Saeed Hemorrhoidial Multi-Band Ligator with TriView? Anoscope | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | ShortShot Saeed Hemorrhoidal Ligator with Triview Anoscope | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | ShortShot? Saeed Hemorrhoidial Multi-Band Ligator with TriView? Anoscope | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | ShortShot Saeed Hemorrhoidal Ligator with Triview Anoscope | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Duette? Multi-Band Mucosectomy | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Duette? Multi-Band Mucosectomy Device | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sonnet? Short Throw Polypectomy Snare | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Fusion? Pushing Catheter | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Fusion? Oasis? ? One Action Stent Introducer System | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Fusion Oasis One Action Stent Introduction System | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF PVP | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | ECHOTIP? ULTRA Celiac Plexus Neurolysis Needle | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Blastocyst Freeze/Thaw Kit | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Embryo Biopsy Medium | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Hyaluronidase (bovine only - not ovine) | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Cystotome | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Cystotome Cystoenterostomy Needle Knife | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Sydney IVF Culture Oil | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Quick-Core? Endoscopic Ultrasound Biopsy Needle | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Quick-Core Ultrasound Biopsy Needle | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | COOK IVF Freeze/Thaw Kits | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | COOK IVF Egg/Embryo Solutions | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | COOK IVF Sperm Solutions | 2019-07-25 |
Cook Medical LLC [COOK MEDICAL] | Zenith? TX2? TAA Endovascular Graft | 2019-07-24 |