FDA Registration
Active
🇺🇸 United States
COOK MEDICAL LLC
Reg #: 3005580113
·
FEI: 3005580113
·
Expires 2026
Products
65
Proprietary Names
201
Establishment Types
2
Classifications
65
Registration Details
- Registration Name
- COOK MEDICAL LLC
- Registration Number
- 3005580113
- FEI Number
- 3005580113
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 400 DANIELS WAY
- City
- Bloomington
- State
- IN
- ZIP
- 47404
- Country
- US
Regulatory Submissions
- 510(k) Number
- K022002
- PMA Number
- P020018
Owner / Operator
- Firm Name
- COOK MEDICAL
- Operator Number
- 9090900
- Address
- 400 DANIELS WAY, --
- City
- Bloomington
- State
- IN
- Postal Code
- 47404
- Country
- US
- Correspondent
- Ed - Sutkowski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2023-06-12 |
| Media, Reproductive | MQL | Class 2 | Obstetrics/Gynecology | No | 2019-07-25 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2025-12-11 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2023-01-06 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-08-11 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2025-08-11 |
| Syringe, Balloon Inflation | MAV | Class 2 | Cardiovascular | No | 2023-01-19 |
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2023-01-19 |
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2019-07-25 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2025-09-01 |
| Filter, Intravascular, Cardiovascular | DTK | Class 2 | Cardiovascular | No | 2024-07-05 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2020-11-09 |
| Endoscopic Transhepatic Venous Access Needle | QIJ | Class 2 | Gastroenterology, Urology | No | 2019-12-06 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2019-07-25 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2025-12-10 |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | Class 1 | General, Plastic Surgery | No | 2023-11-13 |
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2023-11-13 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2025-01-16 |
| Endoscopic Ultrasound System, Gastroenterology-Urology | ODG | Class 2 | Gastroenterology, Urology | No | 2025-01-16 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2025-01-21 |
| Accessory, Assisted Reproduction | MQG | Class 2 | Obstetrics/Gynecology | No | 2019-07-25 |
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | Class 3 | Unknown | No | 2019-07-25 |
| Needle, Assisted Reproduction | MQE | Class 2 | Obstetrics/Gynecology | No | 2019-07-25 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2025-02-18 |
| Snare, Non-Electrical | FGX | Class 1 | Gastroenterology, Urology | No | 2024-09-17 |
| Stent, Iliac Vein | QAN | Class 3 | Unknown | No | 2020-11-09 |
| Prosthesis, Esophageal | ESW | Class 2 | General, Plastic Surgery | No | 2019-07-25 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2025-09-01 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2026-01-13 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2019-07-26 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2023-01-06 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2019-07-25 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2023-01-06 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2023-01-06 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2026-01-13 |
| Stent, Metallic, Expandable, Duodenal | MUM | Class 2 | General, Plastic Surgery | No | 2019-07-25 |
| Stent, Colonic, Metallic, Expandable | MQR | Class 2 | General, Plastic Surgery | No | 2019-07-25 |
| Iliac Covered Stent, Arterial | PRL | Class 3 | Unknown | No | 2024-04-08 |
| Tube, Double Lumen For Intestinal Decompression And/Or Intubation | FEG | Class 2 | Gastroenterology, Urology | No | 2020-03-13 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2019-07-25 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2024-01-03 |
| Stent, Iliac | NIO | Class 3 | Unknown | No | 2019-07-25 |
| Stent, Superficial Femoral Artery | NIP | Class 3 | Unknown | No | 2019-07-25 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2023-11-13 |
| Stent, Superficial Femoral Artery, Drug-Eluting | NIU | Class 3 | Unknown | No | 2019-07-25 |
| Ligator, Hemorrhoidal | FHN | Class 2 | Gastroenterology, Urology | No | 2019-07-25 |
| Anoscope And Accessories | FER | Class 2 | Gastroenterology, Urology | No | 2019-07-25 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2025-09-01 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2023-01-06 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2025-12-10 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2019-07-26 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2019-07-25 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2025-09-01 |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2023-01-06 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2019-07-25 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2019-07-25 |
| Catheter For Crossing Total Occlusions | PDU | Class 2 | Cardiovascular | No | 2024-01-03 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2019-07-26 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2025-09-01 |
| Stent, Renal | NIN | Class 3 | Unknown | No | 2019-07-25 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2024-09-17 |
| Blood Detection Capsule | QUD | Class 2 | Gastroenterology, Urology | No | 2024-06-19 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2023-01-06 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2025-09-01 |
| Endoscope Introducer Kit | NWU | Class 2 | Gastroenterology, Urology | No | 2025-09-02 |
Proprietary Names
Fixed-Core Wire Guides
Sydney IVF Culture Oil
Semi-Automatic Needle
Automatic Biopsy Needle BAM
Automatic Biopsy Needle
Semi-Automatic Needle BIM
Omnitech Electrodes
Peel-Away Sheath Introducer
QL Inflation Device
Transmyometrial Embryo Transfer Set
Sentrus Insufflation Tubing
Sentrus Hybrid Irrigation Tubing
Sentrus Irrigation Tubing
Sentrus Insufflation Tubing with CO2 Connector
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach
Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach
Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
Cook Celect Platinum Vena Cava Filter set for Jugular Vein Approach
Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach
Quanta System Surgical Laser Fibers
EchoTip Ingight Portosystemic Pressure Gradient Measurement System
Entuit Thrive Balloon Retention Gastrostomy Feeding Tube
Sydney IVF PVP
Zilver 635 Biliary Self Expanding Metal Stent
Syfonix Suction Ureteral Access Sheath
Disposable Ureteral Access Sheath
Peel-Away Introducer Set
Peel-Away Introducer Sheath Set
Flexor® Parallel Rapid Release Ureteral Access Sheath
Flexor® Ureteral Access Sheath
Pigtail Drainage Catheter Needle Set
Percutaneous Nephrostomy Set
Nephrostomy Pigtail Drainage Catheter
Multipurpose Drainage Catheters and Sets
EchoTip® ClearCore EUS Biopsy Needle
EchoTip AcuCore EUS Biopsy Needle
Advance Serenity 18 Hydrophilic PTA Balloon Catheter
Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter
Stent Introducer Set
Solus(R) Double Pigtail Stent with Introducer
Oasis-One Action Stent Introduction system(R)
ST-2 Soehendra® Tannenbaum® Biliary Stent
Cotton-Leung Biliary Stent Set
Fusion Oasis One Action Stent Introduction System
Pushing Catheter
Guiding Catheter
Oasis-one action stent introduction system® with Pre-loaded Cotton-Leung® Biliary Stent
Cotton-Huibregtse(R) Biliary Stent
Cotton-Leung® (Amsterdam) Biliary Stent Set
Cotton-Huibregtse® Biliary Stent Set
Fusion® Pushing Catheter
Cotton-Leung® Biliary Stent
Fusion® Oasis® One Action Stent Introducer System
Solus Biliary Stent and Introducer Set
Cotton Leung
Oasis® Stent Introduction System
Zimmon(R) Biliary stent
Huibregtse Guiding Catheter
Zimmon® Biliary Stent Set
Oasis® One Action Stent Introduction System with Pre-Loaded ST-2 Tannenbaum® Biliary Stent
COOK Ultra Quiet Vacuum Pump & Regulator
Sydney IVF Sperm Solutions
MPIS
Zenith Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent)
Ovum Pick-up Aspiration Needle
Wayne Pneumothorax Catheter Set and Tray
Disposable Polypectomy Cold Snare
Zilver® VenaTM Venous Self-Expanding Stent
Lunderquist® Extra Stiff Wire Guide
DC Wire Guides
Adv Serenity 014
COOK Mini-Incubator
Evolution® Esophageal Stent System-Partially Covered
Sentrus Endoscopic Bedside Kit
Sentrus Cleaning Sponge
Sydney IVF Sperm Cryopreservation Buffer
Flexor Guiding Sheath
Flexor Introducer
Ascend Single-Use Flexible Cysto-Nephroscope HD, Standard
Ascend Single-Use Flexible Cysto-Nephroscope HD, Reverse
Ascend Single-Use Flexible Cysto-Nephroscope
Esophageal TTS Stent
Evolution® Esophageal Stent System- Fully Covered
Evolution® Esophageal Controlled-Release Stent -Fully Covered
Mandril Wire Guide
BIGopsy ng forceps
BIGopsy® Backloading Biopsy Forceps
EndoTNeedle
Resonance® Stent Introducer
Resonance Stent Set
Resonance Positioner
Resonance® Metallic Ureteral Stent and Introducer
Compass Cast and MAP
Ascend Single-Use Flexible Ureteroscope, Standard
Endoscopic Video Image Processor HD
Ascend Single-Use Flexible Ureteroscope, Reverse
Niti-S Biliary Stent
Evolution® Duodenal Controlled-Release Stent - Uncovered
Evolution® Duodenal Stent System- Uncovered
iCast covered stent system
Volante Steerable Guiding Sheath
Ascend Single-Use Flexible Ureteroscope
Sydney IVF Hyaluronidase (bovine only - not ovine)
Colon Decompression Set
ECHOTIP® ULTRA Celiac Plexus Neurolysis Needle
Nasal Pancreatic Drainage Set
EchoTip® Ultra High Definition Ultrasound Access Needle
Geenen® Pancreatic Stent Set
Geenen Sofflex Pancreatic Stent
Zimmon® Pancreatic Stent Set
Geenen® Pancreatic Stent
Zimmon® Pancreatic Stent
Johlin Pancreatic Wedge Stent
Nasal Biliary Drainage Catheter
Liguory Nasal Biliary Drainage Set
Liguory Nasal Biliary Drainage Set Radiopaque Tip
Leung Nasal Biliary Drainage Catheter
Nagaraja Nasal Biliary Drainage Set
Liguory Nasal Biliary Drainage Catheter
Leung Nasal Biliary Drainage Set
Nasal Biliary Drainage Set
Nagaraja Nasal Biliary Drainage Catheter
Flexgrip
Zenith Alpha Thoracic Endovascular Graft Proximal Component
Zenith Alpha Thoracic Endovascular Graft Distal Extension
Zenith Alpha Thoracic Endovascular Graft Distal Component
Zenith Alpha Thoracic Endovascular Graft Proximal Tapered Component
Zenith Alpha® 2 Thoracic Endovascular Graft Proximal Component
Zenith Alpha® 2 Thoracic Endovascular Graft Proximal Tapered Component
Zenith Alpha® 2 Thoracic Endovascular Graft Distal Extension
Zenith Alpha® 2 Thoracic Endovascular Graft Distal Component
Sydney IVF Cryopreservation Kit
Sydney IVF Thawing Kit
Zilver 635 Vascular Self-Expanding Stent
Zilver 635® Vascular Stent
Zilver 518 Vascular Self-Expanding Stent
Zilver 518® Vascular Stent
Endovascular Dilator
Dilator Sets
Nylon Dilator
Zilver® PTX® Drug-Eluting Peripheral Stent
ShortShot Saeed Hemorrhoidal Ligator with Triview Anoscope
ShortShot® Saeed Hemorrhoidial Multi-Band Ligator with TriView® Anoscope
Cook Celect Platinum Vena Cava Filter set for Jugular Vein Appraoch
COOK Sydney IVF Blastocyst Vitrification Kit
COOK Sydney IVF Blastocyst Warming Kit
Sentrus Bite Block
Sydney IVF Egg/Embryo Solutions
Zilver 635® Biliary Stent
Zilver 518® Biliary Stent
Zilver 518 Biliary Self-Expanding Stent
ProFusion Therapeutic Infusion Needle
Coaxial Interventional Needle
COOK Test Tube Heater
Disposable Stone Collector
Sydney IVF Embryo Biopsy Medium
Niti-S Esophageal Stent
Double Lumen Ovum Aspiration Needle
Sentrus Dual-End Cleaning Brush
Sentrus Endoscope Transport Bag
Duette® Multi-Band Mucosectomy
Duette® Multi-Band Mucosectomy Device
Sentrus Suction Tubing
COOK IVF Sperm Solutions
Sydney IVF Blastocyst Freeze/Thaw Kit
Towako Transmyometrial Embryo Transfer Set
Sydney IVF Blastocyst Cryopreservation Kit
Sydney IVF Blastocyst Thawing Kit
Otrieva Tapered Ovum Aspiration Needle
COOK IVF Egg/Embryo Solutions
ENFit connector
Feeding Tube with ENFit Connection
Cystotome
Cystotome Cystoenterostomy Needle Knife
Evolution® Biliary Stent System Uncovered
Evolution® Biliary Controlled-Release Stent - Uncovered
Compass BDS Biliary Stents
Frova Intubating introducer
Flipper® 35 Closure Detachable Coil Delivery System
COOK IVF Freeze/Thaw Kits
Bentley BeBack Crossing Catheter
Heraeus Peripheral Guidewire
Single Lumen Ovum Aspiration Needle
Semi-automatic Biopsy-Needle
Murdoch Mechanical Arm
Nathanson Liver Retractor System
COOK Vacuum Pump
Sentrus Endoscopy Adapter Set
Sentrus Auxiliary Water Jet Connector
FormulaTM 414 RX Renal Ballon-Expandable Stent
Disposable Grasping Forceps
Pillsense Capsule
Pillsense Receiver
Adv Serenity 018
Sydney IVF Gamete Buffer
Sentrus Medical Lubricating Jelly
Marcon Colon Decompression Set
Zenith® TX2® Dissection Endovascular Graft with Pro-Form® and the Z-Trak® Plus Introduction System -Tapered Component
Zenith® Dissection Endovascular Stent with the Z-Trak® Plus Introduction System
Zenith® TX2® Dissection Endovascular Graft with Pro-Form® and the Z-Trak® Plus Introduction System-Straight Component
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198