Cook Medical L L C

FDA Filings

This page includes the latest FDA filings for Cook Medical L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• 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:
  • Ed - Sutkowski
  • x-812-3392235-x
• 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:
  • Ed - Sutkowski
  • x-812-3392235-x
• 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)

FDA Filings

Device Company	Device	Date
PMN K171619 | FEG Cook Medical LLC [COOK MEDICAL]	Colon Decompression Set	2020-03-13
PMN DEN180062 | QIJ Cook Medical LLC [COOK MEDICAL]	EchoTip Ingight Portosystemic Pressure Gradient Measurement System	2019-12-06
PMN K180868 | FGE Cook Medical LLC [COOK MEDICAL]	Nasal Biliary Drainage Set	2019-10-31
PMN K180868 | FGE Cook Medical LLC [COOK MEDICAL]	Nagaraja Nasal Biliary Drainage Set	2019-10-31
PMN K180868 | FGE Cook Medical LLC [COOK MEDICAL]	Liguory Nasal Biliary Drainage Set	2019-10-31
PMN K180868 | FGE Cook Medical LLC [COOK MEDICAL]	Leung Nasal Biliary Drainage Set	2019-10-31
PMN K171623 | FGE Cook Medical LLC [COOK MEDICAL]	Nasal Pancreatic Drainage Set	2019-10-31
PMN K173431 | MQF Cook Medical LLC [COOK MEDICAL]	Towako Transmyometrial Embryo Transfer Set	2019-09-04
MNL Cook Medical LLC [COOK MEDICAL]	Disposable Endoscopic Cleaning Brush	2019-07-26
MNL Cook Medical LLC [COOK MEDICAL]	Disposable Endoscopic Cleaning Brush Set	2019-07-26
GAD Cook Medical LLC [COOK MEDICAL]	Nathanson Liver Retractor System	2019-07-26
GAD Cook Medical LLC [COOK MEDICAL]	Murdoch Mechanical Arm	2019-07-26
FCL Cook Medical LLC [COOK MEDICAL]	BIGopsy? Backloading Biopsy Forceps	2019-07-26
FCL Cook Medical LLC [COOK MEDICAL]	BIGopsy ng forceps	2019-07-26
PMN P180001 | MIH 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
PMN P180001 | MIH 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
PMN P180001 | MIH Cook Medical LLC [COOK MEDICAL]	Zenith? Dissection Endovascular Stent with the Z-Trak? Plus Introduction System	2019-07-25
PMN P140016 | MIH Cook Medical LLC [COOK MEDICAL]	Zenith Alpha? Thoracic Endovascular Graft ? Proximal Tapered Component	2019-07-25
PMN P140016 | MIH Cook Medical LLC [COOK MEDICAL]	Zenith Alpha? Thoracic Endovascular Graft ? Proximal Component	2019-07-25
PMN P140016 | MIH Cook Medical LLC [COOK MEDICAL]	Zenith Alpha? Thoracic Endovascular Graft ? Distal Extension	2019-07-25
PMN P140016 | MIH Cook Medical LLC [COOK MEDICAL]	Zenith Alpha? Thoracic Endovascular Graft ? Distal Component	2019-07-25
PMN P100028 | NIN Cook Medical LLC [COOK MEDICAL]	FormulaTM 414 RX Renal Ballon-Expandable Stent	2019-07-25
PMN P100022 | NIU Cook Medical LLC [COOK MEDICAL]	Zilver? PTX? Drug-Eluting Peripheral Stent	2019-07-25
PMN P100022 | NIU Cook Medical LLC [COOK MEDICAL]	Zilver? PTX? Drug Eluting Peripheral Stent SET	2019-07-25
PMN P050017 | NIO Cook Medical LLC [COOK MEDICAL]	Zilver 635? Vascular Stent	2019-07-25
PMN P050017 | NIO Cook Medical LLC [COOK MEDICAL]	Zilver 635 Vascular Self-Expanding Stent	2019-07-25
PMN P050017 | NIO Cook Medical LLC [COOK MEDICAL]	Zilver 518? Vascular Stent	2019-07-25
PMN P050017 | NIO Cook Medical LLC [COOK MEDICAL]	Zilver 518 Vascular Self-Expanding Stent	2019-07-25
PMN P020018 | MIH Cook Medical LLC [COOK MEDICAL]	Zenith Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent)	2019-07-25
PMN K992070 | MQG Cook Medical LLC [COOK MEDICAL]	COOK Ultra Quiet Vacuum Pump & Regulator	2019-07-25
PMN K990130 | FGE Cook Medical LLC [COOK MEDICAL]	Johlin Pancreatic Wedge Stent	2019-07-25
PMN K983642 | MQG Cook Medical LLC [COOK MEDICAL]	COOK Mini-Incubator	2019-07-25
PMN K983609 | MQG Cook Medical LLC [COOK MEDICAL]	COOK Test Tube Heater	2019-07-25
PMN K983595 | MQF Cook Medical LLC [COOK MEDICAL]	Transmyometrial Embryo Transfer Set	2019-07-25
PMN K983593 | MQE Cook Medical LLC [COOK MEDICAL]	Ovum Pick-up Aspiration Needle	2019-07-25
PMN K900923 | FGE Cook Medical LLC [COOK MEDICAL]	Zimmon? Pancreatic Stent	2019-07-25
PMN K900923 | FGE Cook Medical LLC [COOK MEDICAL]	Zimmon? Pancreatic Stent Set	2019-07-25
PMN K900923 | FGE Cook Medical LLC [COOK MEDICAL]	Pancreatic Stent	2019-07-25
PMN K900923 | FGE Cook Medical LLC [COOK MEDICAL]	Greenen Sofflex	2019-07-25
PMN K900923 | FGE Cook Medical LLC [COOK MEDICAL]	Geenen? Pancreatic Stent	2019-07-25
PMN K900923 | FGE Cook Medical LLC [COOK MEDICAL]	Geenen? Pancreatic Stent Set	2019-07-25
PMN K900035 | FEG Cook Medical LLC [COOK MEDICAL]	Marcon Colon Decompression Set	2019-07-25
PMN K900035 | FEG Cook Medical LLC [COOK MEDICAL]	Colon Decompression Set	2019-07-25
PMN K896323 | FGE Cook Medical LLC [COOK MEDICAL]	Nasal Biliary Drainage Set	2019-07-25
PMN K896323 | FGE Cook Medical LLC [COOK MEDICAL]	Nasal Biliary Drainage Catheter	2019-07-25
PMN K896323 | FGE Cook Medical LLC [COOK MEDICAL]	Nagaraja Nasal Biliary Drainage Set	2019-07-25
PMN K896323 | FGE Cook Medical LLC [COOK MEDICAL]	Nagaraja Nasal Biliary Drainage Catheter	2019-07-25
PMN K896323 | FGE Cook Medical LLC [COOK MEDICAL]	Liguory Nasal Biliary Drainage Set	2019-07-25
PMN K896323 | FGE Cook Medical LLC [COOK MEDICAL]	Liguory Nasal Biliary Drainage Set Radiopaque Tip	2019-07-25
PMN K896323 | FGE Cook Medical LLC [COOK MEDICAL]	Liguory Nasal Biliary Drainage Catheter	2019-07-25
PMN K896323 | FGE Cook Medical LLC [COOK MEDICAL]	Leung Nasal Biliary Drainage Set	2019-07-25
PMN K896323 | FGE Cook Medical LLC [COOK MEDICAL]	Leung Nasal Biliary Drainage Catheter	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Zimmon? Biliary Stent Set	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Zimmon(R) Biliary stent	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Stent Introducer Set	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Solus(R) Double Pigtail Stent with Introducer	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Solus Biliary Stent and Introducer Set	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	ST-2 Soehendra? Tannenbaum? Biliary Stent	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Pushing Catheter	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Oasis? Stent Introduction System	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Oasis? One Action Stent Introduction System	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Oasis? One Action Stent Introduction System with Pre-Loaded ST-2 Tannenbaum? Biliary Stent	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Oasis-one action stent introduction system? with Pre-loaded Cotton-Leung? Biliary Stent	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Oasis-One Action Stent Introduction system(R)	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Huibregtse-Katon Pusher	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Huibregtse Guiding Catheter	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Guiding Catheter	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Cotton-Leung? Biliary Stent	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Cotton-Leung? (Amsterdam) Biliary Stent Set	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Cotton-Leung Biliary Stent Set	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Cotton-Huibregtse? Biliary Stent Set	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Cotton-Huibregtse(R) Biliary Stent	2019-07-25
PMN K851962 | FGE Cook Medical LLC [COOK MEDICAL]	Cotton Leung	2019-07-25
PMN K182980 | FGE Cook Medical LLC [COOK MEDICAL]	Zilver 635? Biliary Stent	2019-07-25
PMN K182980 | FGE Cook Medical LLC [COOK MEDICAL]	Zilver 518? Biliary Stent	2019-07-25
PMN K182980 | FGE Cook Medical LLC [COOK MEDICAL]	Zilver 518 Biliary Self-Expanding Stent	2019-07-25
PMN K172557 | DTK Cook Medical LLC [COOK MEDICAL]	Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach	2019-07-25
PMN K172557 | DTK Cook Medical LLC [COOK MEDICAL]	Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach	2019-07-25
PMN K172557 | DTK Cook Medical LLC [COOK MEDICAL]	Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach	2019-07-25
PMN K171712 | DTK Cook Medical LLC [COOK MEDICAL]	Cook Celect Platinum Vena Cava Filter set for Jugular Vein Appraoch	2019-07-25
PMN K171712 | DTK Cook Medical LLC [COOK MEDICAL]	Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach	2019-07-25
PMN K171712 | DTK Cook Medical LLC [COOK MEDICAL]	Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach	2019-07-25
PMN K171625 | MQE Cook Medical LLC [COOK MEDICAL]	Single Lumen Ovum Aspiration Needle	2019-07-25
PMN K171611 | MQE Cook Medical LLC [COOK MEDICAL]	Double Lumen Ovum Aspiration Needle	2019-07-25
PMN K171513 | DQX Cook Medical LLC [COOK MEDICAL]	Lunderquist? Extra Stiff Wire Guide	2019-07-25
PMN K171513 | DQX Cook Medical LLC [COOK MEDICAL]	DC Wire Guides	2019-07-25
PMN K170257 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Culture Oil	2019-07-25
PMN K163468 | MUM Cook Medical LLC [COOK MEDICAL]	Evolution? Duodenal Stent System- Uncovered	2019-07-25
PMN K163468 | MUM Cook Medical LLC [COOK MEDICAL]	Evolution? Duodenal Controlled-Release Stent - Uncovered	2019-07-25
PMN K163468 | MQR Cook Medical LLC [COOK MEDICAL]	Evolution? Duodenal Stent System- Uncovered	2019-07-25
PMN K163468 | MQR Cook Medical LLC [COOK MEDICAL]	Evolution? Duodenal Controlled-Release Stent - Uncovered	2019-07-25
PMN K163018 | FGE Cook Medical LLC [COOK MEDICAL]	Zilver 635 Biliary Self Expanding Metal Stent	2019-07-25
PMN K162717 | ESW Cook Medical LLC [COOK MEDICAL]	Evolution? Esophageal Stent System-Partially Covered	2019-07-25
PMN K161813 | BTR Cook Medical LLC [COOK MEDICAL]	Frova Intubating introducer	2019-07-25
PMN K160814 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Sperm Cryopreservation Buffer	2019-07-25
PMN K160753 | MQG Cook Medical LLC [COOK MEDICAL]	COOK Vacuum Pump	2019-07-25
PMN K160229 | FCG Cook Medical LLC [COOK MEDICAL]	Echotip Procore? Endobronchial HD Ultrasound Biopsy Needle for Olympus Scopes	2019-07-25
PMN K160229 | FCG Cook Medical LLC [COOK MEDICAL]	EchoTip? Ultra Endobronchial High Definition Ultrasound Needle	2019-07-25
PMN K153478 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Gamete Buffer	2019-07-25
PMN K153290 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Egg/Embryo Solutions	2019-07-25
PMN K152904 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Embryo Biopsy Medium	2019-07-25
PMN K152782 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Sperm Solutions	2019-07-25
PMN K152717 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Blastocyst Thawing Kit	2019-07-25
PMN K152717 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Blastocyst Cryopreservation Kit	2019-07-25
PMN K152682 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Thawing Kit	2019-07-25
PMN K152682 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Cryopreservation Kit	2019-07-25
PMN K152440 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF PVP	2019-07-25
PMN K151367 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Egg/Embryo Solutions	2019-07-25
PMN K150964 | KRD Cook Medical LLC [COOK MEDICAL]	Flipper? Detachable Embolization Coils	2019-07-25
PMN K150964 | KRD Cook Medical LLC [COOK MEDICAL]	Flipper? 35 Closure Detachable Coil Delivery System	2019-07-25
PMN K143724 | MQL Cook Medical LLC [COOK MEDICAL]	COOK Sydney IVF Blastocyst Warming Kit	2019-07-25
PMN K143724 | MQL Cook Medical LLC [COOK MEDICAL]	COOK Sydney IVF Blastocyst Vitrification Kit	2019-07-25
PMN K142688 | FCG Cook Medical LLC [COOK MEDICAL]	ECHOTIP PROCORE? HD ULTRASOUND BIOPSY NEEDLE	2019-07-25
PMN K141365 | MQE Cook Medical LLC [COOK MEDICAL]	Otrieva Tapered Ovum Aspiration Needle	2019-07-25
PMN K121430 | FGE Cook Medical LLC [COOK MEDICAL]	Evolution? Biliary Stent System Uncovered	2019-07-25
PMN K121430 | FGE Cook Medical LLC [COOK MEDICAL]	Evolution? Biliary Controlled-Release Stent - Uncovered	2019-07-25
PMN K093619 | ESW Cook Medical LLC [COOK MEDICAL]	Evolution? Esophageal Stent System- Fully Covered	2019-07-25
PMN K093619 | ESW Cook Medical LLC [COOK MEDICAL]	Evolution? Esophageal Controlled-Release Stent -Fully Covered	2019-07-25
PMN K092359 | FCG Cook Medical LLC [COOK MEDICAL]	EchoTip? Ultra High Definition Ultrasound Access Needle	2019-07-25
PMN K083330 | FCG Cook Medical LLC [COOK MEDICAL]	EchoTip? Ultra Endoscopic Ultrasound Needle	2019-07-25
PMN K082363 | MQL Cook Medical LLC [COOK MEDICAL]	COOK Sydney IVF Blastocyst Warming Kit	2019-07-25
PMN K082363 | MQL Cook Medical LLC [COOK MEDICAL]	COOK Sydney IVF Blastocyst Vitrification Kit	2019-07-25
PMN K063742 | FAD Cook Medical LLC [COOK MEDICAL]	Resonance? Stent Introducer	2019-07-25
PMN K063742 | FAD Cook Medical LLC [COOK MEDICAL]	Resonance? Metallic Ureteral Stent and Introducer	2019-07-25
PMN K063742 | FAD Cook Medical LLC [COOK MEDICAL]	Resonance Stent Set	2019-07-25
PMN K063742 | FAD Cook Medical LLC [COOK MEDICAL]	Resonance Positioner	2019-07-25
PMN K061371 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Sperm Cryopreservation Buffer	2019-07-25
PMN K060624 | FGE Cook Medical LLC [COOK MEDICAL]	Fusion? Marathon? Anti-Reflux Biliary Stent	2019-07-25
PMN K060623 | FHN Cook Medical LLC [COOK MEDICAL]	ShortShot? Saeed Hemorrhoidial Multi-Band Ligator with TriView? Anoscope	2019-07-25
PMN K060623 | FHN Cook Medical LLC [COOK MEDICAL]	ShortShot Saeed Hemorrhoidal Ligator with Triview Anoscope	2019-07-25
PMN K060623 | FER Cook Medical LLC [COOK MEDICAL]	ShortShot? Saeed Hemorrhoidial Multi-Band Ligator with TriView? Anoscope	2019-07-25
PMN K060623 | FER Cook Medical LLC [COOK MEDICAL]	ShortShot Saeed Hemorrhoidal Ligator with Triview Anoscope	2019-07-25
PMN K050578 | KNS Cook Medical LLC [COOK MEDICAL]	Duette? Multi-Band Mucosectomy	2019-07-25
PMN K050578 | KNS Cook Medical LLC [COOK MEDICAL]	Duette? Multi-Band Mucosectomy Device	2019-07-25
PMN K050294 | FDI Cook Medical LLC [COOK MEDICAL]	Sonnet? Short Throw Polypectomy Snare	2019-07-25
PMN K040151 | FGE Cook Medical LLC [COOK MEDICAL]	Fusion? Pushing Catheter	2019-07-25
PMN K040151 | FGE Cook Medical LLC [COOK MEDICAL]	Fusion? Oasis? ? One Action Stent Introducer System	2019-07-25
PMN K040151 | FGE Cook Medical LLC [COOK MEDICAL]	Fusion Oasis One Action Stent Introduction System	2019-07-25
PMN K031304 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF PVP	2019-07-25
PMN K030618 | BSP Cook Medical LLC [COOK MEDICAL]	ECHOTIP? ULTRA Celiac Plexus Neurolysis Needle	2019-07-25
PMN K030441 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Blastocyst Freeze/Thaw Kit	2019-07-25
PMN K023850 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Embryo Biopsy Medium	2019-07-25
PMN K023353 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Hyaluronidase (bovine only - not ovine)	2019-07-25
PMN K022595 | KNS Cook Medical LLC [COOK MEDICAL]	Cystotome	2019-07-25
PMN K022595 | KNS Cook Medical LLC [COOK MEDICAL]	Cystotome Cystoenterostomy Needle Knife	2019-07-25
PMN K022002 | MQL Cook Medical LLC [COOK MEDICAL]	Sydney IVF Culture Oil	2019-07-25
PMN K013356 | FCG Cook Medical LLC [COOK MEDICAL]	Quick-Core? Endoscopic Ultrasound Biopsy Needle	2019-07-25
PMN K013356 | FCG Cook Medical LLC [COOK MEDICAL]	Quick-Core Ultrasound Biopsy Needle	2019-07-25
PMN K011157 | MQL Cook Medical LLC [COOK MEDICAL]	COOK IVF Freeze/Thaw Kits	2019-07-25
PMN K002385 | MQL Cook Medical LLC [COOK MEDICAL]	COOK IVF Egg/Embryo Solutions	2019-07-25
PMN K002383 | MQL Cook Medical LLC [COOK MEDICAL]	COOK IVF Sperm Solutions	2019-07-25
PMN P070016 | MIH Cook Medical LLC [COOK MEDICAL]	Zenith? TX2? TAA Endovascular Graft	2019-07-24

Similar & Related FDA Registered Companies

• COOK MEDICAL INCORPORATEDsandet 6bjaeverskov 4632 PMA NumberP140016 Supplement NumberS005 Date Received03/18/2022 Decision Date04/14/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	393H0	COOK MEDICAL LLC!DBA COOK MEDICAL
CAGE Code	393H0	COOK MEDICAL LLC COOK MEDICAL
S.A.M. Registration	393H0 [169601999]	COOK MEDICAL LLC COOK MEDICAL