Data / Medical devices / United States / Cook Medical LLC

Cook Medical LLC: FDA-registered device maker in Bloomington, IN, United States, 90 510(k) clearances and 8 PMA approvals

Name: Cook Medical LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cook Medical LLC is registered with the FDA (registration 3005580113) in Bloomington, IN, United States. It lists 67 device types. The FDA files 90 510(k) clearances and 8 PMA approvals under its listings, the newest dated December 16, 2025. 8 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Cook Medical LLC

FDA registration number: 3005580113
Address: 400 Daniels Way, Bloomington, IN, United States, 47404
Owner or operator: COOK MEDICAL (9090900)
Roles: Complaint file establishment, Contract manufacturer
First device listed: November 14, 2013
Registered through: 2027
Brand names listed: Adv Serenity 014, Adv Serenity 018, Advance Serenity 18 Hydrophilic PTA Balloon Catheter, Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter, Ascend Single-Use Flexible Ureteroscope, Ascend Single-Use Flexible Cysto-Nephroscope, Ascend Single-Use Flexible Cysto-Nephroscope HD, Reverse, Ascend Single-Use Flexible Cysto-Nephroscope HD, Standard and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Complaint file establishment	accessdata.fda.gov
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Complaint file establishment	accessdata.fda.gov
Accessory, Assisted Reproduction	MQG	2	Complaint file establishment	accessdata.fda.gov
Anoscope And Accessories	FER	2	Complaint file establishment	accessdata.fda.gov
Biopsy Needle	FCG	2	Complaint file establishment	accessdata.fda.gov
Blood Detection Capsule	QUD	2	Complaint file establishment	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Contract manufacturer	accessdata.fda.gov
Catheter For Crossing Total Occlusions	PDU	2	Complaint file establishment	accessdata.fda.gov
Catheter, Angioplasty, Peripheral, Transluminal	LIT	2	Complaint file establishment	accessdata.fda.gov
Catheter, Assisted Reproduction	MQF	2	Complaint file establishment	accessdata.fda.gov
Catheter, Nephrostomy	LJE	U	Contract manufacturer	accessdata.fda.gov
Catheter, Nephrostomy, General & Plastic Surgery	GBO	1	Contract manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Complaint file establishment	accessdata.fda.gov
Catheter, Ureteral, Gastro-Urology	EYB	2	Contract manufacturer	accessdata.fda.gov
Catheter, Urological	KOD	2	Contract manufacturer	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Complaint file establishment	accessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-Function	DXG	2	Complaint file establishment	accessdata.fda.gov
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Complaint file establishment	accessdata.fda.gov
Device, Vascular, For Promoting Embolization	KRD	2	Complaint file establishment	accessdata.fda.gov
Dilator, Urethral	KOE	2	Complaint file establishment	accessdata.fda.gov
Dilator, Vessel, For Percutaneous Catheterization	DRE	2	Contract manufacturer	accessdata.fda.gov
Electrode, Electrosurgical, Active, Urological	FAS	2	Complaint file establishment	accessdata.fda.gov
Endoscope Channel Accessory	ODC	2	Complaint file establishment	accessdata.fda.gov
Endoscope Introducer Kit	NWU	2	Complaint file establishment	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Complaint file establishment	accessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	PTS	2	Complaint file establishment	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Complaint file establishment	accessdata.fda.gov
Endoscopic Irrigation/Suction System	OCX	2	Complaint file establishment	accessdata.fda.gov
Endoscopic Transhepatic Venous Access Needle	QIJ	2	Complaint file establishment	accessdata.fda.gov
Endoscopic Ultrasound System, Gastroenterology-Urology	ODG	2	Complaint file establishment	accessdata.fda.gov
Filter, Intravascular, Cardiovascular	DTK	2	Complaint file establishment	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Complaint file establishment	accessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	2	Complaint file establishment	accessdata.fda.gov
Iliac Covered Stent, Arterial	PRL	3	Complaint file establishment	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Complaint file establishment	accessdata.fda.gov
Introducer, Catheter	DYB	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Complaint file establishment	accessdata.fda.gov
Lubricant, Patient	KMJ	1	Complaint file establishment	accessdata.fda.gov
Media, Reproductive	MQL	2	Complaint file establishment	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Complaint file establishment	accessdata.fda.gov
Needle, Assisted Reproduction	MQE	2	Complaint file establishment	accessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	2	Complaint file establishment	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment	accessdata.fda.gov
Prosthesis, Esophageal	ESW	2	Complaint file establishment	accessdata.fda.gov
Retractor	GAD	1	Complaint file establishment	accessdata.fda.gov
Snare, Non-Electrical	FGX	1	Complaint file establishment	accessdata.fda.gov
Stent, Colonic, Metallic, Expandable	MQR	2	Complaint file establishment	accessdata.fda.gov
Stent, Iliac	NIO	3	Complaint file establishment	accessdata.fda.gov
Stent, Iliac Vein	QAN	3	Complaint file establishment	accessdata.fda.gov
Stent, Metallic, Expandable, Duodenal	MUM	2	Complaint file establishment	accessdata.fda.gov
Stent, Renal	NIN	3	Complaint file establishment	accessdata.fda.gov
Stent, Superficial Femoral Artery	NIP	3	Complaint file establishment	accessdata.fda.gov
Stent, Superficial Femoral Artery, Drug-Eluting	NIU	3	Complaint file establishment	accessdata.fda.gov
Stent, Ureteral	FAD	2	Complaint file establishment	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Syringe, Balloon Inflation	MAV	2	Complaint file establishment	accessdata.fda.gov
System, Endovascular Graft, Aortic Aneurysm Treatment	MIH	3	Complaint file establishment	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Complaint file establishment	accessdata.fda.gov
Transducer, Blood-Pressure, Extravascular	DRS	2	Complaint file establishment	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Complaint file establishment	accessdata.fda.gov
Tube, Double Lumen For Intestinal Decompression And/Or Intubation	FEG	2	Complaint file establishment	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Complaint file establishment	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Complaint file establishment	accessdata.fda.gov
Ureteroscope And Accessories, Flexible/Rigid	FGB	2	Complaint file establishment	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 16, 2025	K251951	Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)	FGB	Substantially Equivalent	Guangzhou Red Pine Medical Instrument Co., Ltd.	accessdata.fda.gov
November 9, 2025	K251596	Lunderquist Extra Stiff Wire Guide	DQX	Substantially Equivalent	William Cook Europe Aps	accessdata.fda.gov
September 5, 2025	K250132	Ureteral Access Sheath	FED	Substantially Equivalent	Zhejiang YiGao Medical Technology Co., Ltd.	accessdata.fda.gov
August 8, 2025	K252176	Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)	FAJ	Substantially Equivalent	Guangzhou Red Pine Medical Instrument Co., Ltd.	accessdata.fda.gov
June 11, 2025	K251499	Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)	BTR	Substantially Equivalent	William Cook Europe Aps	accessdata.fda.gov
November 15, 2024	K242419	018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter	LIT	Substantially Equivalent	Creagh Medical Ltd. Dba Surmodics, Inc.	accessdata.fda.gov
July 29, 2024	K241209	EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)	FCG	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
June 18, 2024	K233294	Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM	KNW	Substantially Equivalent	Itp Innovative Tomography Products GmbH	accessdata.fda.gov
June 14, 2024	K233079	Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)	FGE	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
January 18, 2024	K233680	Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter	DTK	Substantially Equivalent	William Cook Europe Aps	accessdata.fda.gov
May 30, 2023	K230909	EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)	FCG	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
March 6, 2023	K221158	Single-Use Video Flexible Ureterorenoscope System	FGB	Substantially Equivalent	Guangzhou Red Pine Medical Instrument Co., Ltd.	accessdata.fda.gov
February 24, 2023	DEN220065	Pill Sense System	QUD	Unknown	Enterasense , Ltd.	accessdata.fda.gov
January 20, 2023	K222462	Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)	KNW	Substantially Equivalent	Itp Innovative Tomography Products GmbH	accessdata.fda.gov
September 27, 2022	K220785	Clean Connecting Tube	OCX	Substantially Equivalent	Yangzhou Fartley Medical Instrument Technology Co., Ltd.	accessdata.fda.gov
June 22, 2022	K221482	Esophageal TTS Stent	ESW	Substantially Equivalent	Taewoong Medical Co., Ltd.	accessdata.fda.gov
June 17, 2022	K220210	Disposable Endoscopy Adapter Set	ODC	Substantially Equivalent	Yangzhou Fartley Medical Instrument Technology Co., Ltd.	accessdata.fda.gov
May 9, 2022	K213946	Compass BDS Biliary Stent	FGE	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
March 1, 2022	K211802	GoBack Crossing Catheter	PDU	Substantially Equivalent	Upstream Peripheral Technologies, Ltd.	accessdata.fda.gov
February 17, 2022	K220137	Lunderquist Extra Stiff Wire Guide	DQX	Substantially Equivalent	William Cook Europe Aps	accessdata.fda.gov
February 25, 2020	K200234	Surgical laser fibers	GEX	Substantially Equivalent	Quanta System Spa	accessdata.fda.gov
November 26, 2019	K191502	Heraeus Peripheral Guidewire	DQX	Substantially Equivalent	Heraeus Medical Components, LLC	accessdata.fda.gov
November 20, 2019	DEN180062	EchoTip Insight Portosystemic Pressure Gradient Measuring System	QIJ	Unknown	Cook Ireland, Ltd.	accessdata.fda.gov
November 16, 2018	K182980	Zilver 518 Biliary Stent, Zilver 635 Biliary Stent	FGE	Unknown	Cook Ireland, Ltd.	accessdata.fda.gov
July 6, 2018	K180868	Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set	FGE	Substantially Equivalent	Cook Ireland	accessdata.fda.gov
May 18, 2018	K173431	Towako Transmyometrial Embryo Transfer Set	MQF	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.	accessdata.fda.gov
April 19, 2018	K180007	018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter	LIT	Substantially Equivalent	Creagh Medical, Ltd.	accessdata.fda.gov
January 12, 2018	K171625	Single Lumen Ovum Aspiration Needles	MQE	Substantially Equivalent	Willian A. Cook Australia Pty, Ltd.	accessdata.fda.gov
December 15, 2017	K171611	Double Lumen Ovum Aspiration Needles	MQE	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.	accessdata.fda.gov
December 7, 2017	K171513	Lunderquist Extra Stiff Wire Guide	DQX	Substantially Equivalent	William Cook Europe Aps	accessdata.fda.gov
November 20, 2017	K172557	Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach	DTK	Substantially Equivalent	William Cook Europe Aps	accessdata.fda.gov
September 8, 2017	K171251	014 Hydrophilic Coated PTA Balloon Dilatation Catheter	LIT	Substantially Equivalent	Creagh Medical	accessdata.fda.gov
August 7, 2017	K171712	Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach	DTK	Substantially Equivalent	William Cook Europe Aps	accessdata.fda.gov
August 1, 2017	K171619	14Fr Colon Decompression Set, Macon Colon Decompression Set	FEG	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
July 31, 2017	K171623	Nasal Pancreatic Drainage Set	FGE	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
June 13, 2017	K160753	COOK Vacuum Pump	MQG	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.	accessdata.fda.gov
June 6, 2017	K171347	Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection	PIF	Substantially Equivalent	Xeridiem Medical Devices	accessdata.fda.gov
May 19, 2017	K161813	Frova Intubating Introducer	BTR	Substantially Equivalent	William Cook Europe Aps	accessdata.fda.gov
May 4, 2017	K163468	Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered	MUM	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
February 24, 2017	K170257	Sydney IVF Culture Oil	MQL	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.	accessdata.fda.gov
December 23, 2016	K163018	Zilver 635 Biliary Stent	FGE	Unknown	Cook Ireland, Ltd.	accessdata.fda.gov
December 21, 2016	K162717	Evolution Esophageal Stent System Partially Covered	ESW	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
November 22, 2016	K161408	Compass Cast and MAP	DRS	Substantially Equivalent	Centurion Medical Products Corporation	accessdata.fda.gov
August 15, 2016	K153478	Sydney IVF Gamete Buffer	MQL	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.	accessdata.fda.gov
June 27, 2016	K151976	Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode	FAS	Substantially Equivalent	Omnitech Systems, Inc.	accessdata.fda.gov
May 6, 2016	K152717	Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit	MQL	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.	accessdata.fda.gov
May 5, 2016	K152682	Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit	MQL	Substantially Equivalent	Willian A. Cook Australia Pty, Ltd.	accessdata.fda.gov
April 22, 2016	K160814	Sydney IVF Sperm Cryopreservation Buffer	MQL	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.	accessdata.fda.gov
March 18, 2016	K160513	Quanta System Surgical Laser fibers	GEX	Substantially Equivalent	Quanta System Spa	accessdata.fda.gov
January 27, 2016	K153290	Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium	MQL	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.	accessdata.fda.gov
January 27, 2016	K151367	Sydney IVF Hyaluronidase	MQL	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.	accessdata.fda.gov
December 21, 2015	K152782	SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT	MQL	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.	accessdata.fda.gov
December 18, 2015	K150964	MReye Flipper Detachable Embolization Coil and Delivery System	KRD	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
December 3, 2015	K152904	SYDNEY IVF EMBRYO BIOPSY MEDIUM	MQL	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.	accessdata.fda.gov
September 23, 2015	K152440	Sydney IVF PVP	MQL	Substantially Equivalent	Willam A. Cook Australia Pty, Ltd.	accessdata.fda.gov
August 27, 2015	K143724	COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit	MQL	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.	accessdata.fda.gov
August 7, 2014	K141365	OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN	MQE	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.	accessdata.fda.gov
April 17, 2014	K140406	DESTINO TWIST, STEERABLE GUIDING SHEATH	DYB	Substantially Equivalent	Oscor, Inc.	accessdata.fda.gov
December 19, 2013	K130611	ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE	KNT	Substantially Equivalent	Xeridiem Medical Devices	accessdata.fda.gov
October 24, 2013	K131473	(QUANTA SYSTEM) SURGICAL LASER FIBERS	GEX	Substantially Equivalent	Quanta System Spa	accessdata.fda.gov
March 1, 2013	K121430	EVOLUTION BILIARY STENT SYSTEM	FGE	Unknown	Cook Ireland, Ltd.	accessdata.fda.gov
June 17, 2010	K093619	EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E	ESW	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
November 2, 2009	K092359	ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A	FCG	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
April 29, 2009	K082363	COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS	MQL	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.	accessdata.fda.gov
January 30, 2009	K080782	NITI-S ESOPHAGEAL STENT	ESW	Substantially Equivalent	Taewoong Medical Co., Ltd.	accessdata.fda.gov
November 19, 2008	K073667	NITI-S BILIARY STENT	FGE	Unknown	Taewoong Medical Co., Ltd.	accessdata.fda.gov
May 8, 2007	K063742	RESONANCE METALLIC URETERAL STENT	FAD	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
September 6, 2006	K060623	SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE	FER	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
August 17, 2006	K061371	SYDNEY IVF SPERM CRYOPRESERVATION BUFFER	MQL	Substantially Equivalent	Cook Urological, Inc.	accessdata.fda.gov
April 22, 2005	K050578	COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE	KNS	Substantially Equivalent	Cook Ireland, Ltd.	accessdata.fda.gov
March 23, 2004	K031304	SYDNEY IVF PVP	MQL	Substantially Equivalent	Cook Urological, Inc.	accessdata.fda.gov
March 3, 2004	K032840	ATRION MEDICAL QL INFLATION DEVICE	KOE	Substantially Equivalent	Atrion Medical Products, Inc.	accessdata.fda.gov
August 29, 2003	K030441	SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT	MQL	Substantially Equivalent	Cook Ob/Gyn	accessdata.fda.gov
May 27, 2003	K030618	WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE	BSP	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov
January 22, 2003	K023850	SYDNEY IVF EMBRYO BIOPSY MEDIUM	MQL	Substantially Equivalent	Cook Ob/Gyn	accessdata.fda.gov
December 20, 2002	K023353	SYDNEY IVF HYALURONIDASE	MQL	Substantially Equivalent	Cook Urological, Inc.	accessdata.fda.gov
October 17, 2002	K022595	WILSON-COOK CYSTOTOME	KNS	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov
August 12, 2002	K022002	SYDNEY IVF CULTURE OIL	MQL	Substantially Equivalent	Cook Urological, Inc.	accessdata.fda.gov
November 2, 2001	K012977	VARICES INJECTION NEEDLE	FBK	Substantially Equivalent	Endo-Therapeutics, Inc.	accessdata.fda.gov
May 3, 2001	K011157	COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT	MQL	Substantially Equivalent	Cook Urological, Inc.	accessdata.fda.gov
September 18, 2000	K002385	COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,	MQL	Substantially Equivalent	Cook Ob/Gyn	accessdata.fda.gov
September 13, 2000	K002383	COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT	MQL	Substantially Equivalent	Cook Ob/Gyn	accessdata.fda.gov
October 27, 1999	K992070	COOK ULTRA QUIET VACUUM PUMP & REGULATOR	MQG	Substantially Equivalent	Cook Urological, Inc.	accessdata.fda.gov
February 12, 1999	K990130	WILSON-COOK PANCREATIC WEDGE STENT	FGE	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov
February 8, 1999	K983595	TRANSMYOMETRIAL EMBRYO TRANSFER SET	MQF	Substantially Equivalent	Cook Ob/Gyn	accessdata.fda.gov
February 1, 1999	K983642	COOK MINI-INCUBATOR	MQG	Substantially Equivalent	Cook Ob/Gyn	accessdata.fda.gov
January 21, 1999	K983593	OVUM PICK-UP ASPIRATION NEEDLES	MQE	Substantially Equivalent	Cook Ob/Gyn	accessdata.fda.gov
December 16, 1998	K983609	COOK TEST TUBE HEATER	MQG	Substantially Equivalent	Cook Ob/Gyn	accessdata.fda.gov
April 9, 1990	K896323	WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS	FGE	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov
March 7, 1990	K900035	WILSON-COOK COLON DECOMPRESSION SET	FEG	Substantially Equivalent	Wilson-Cook Medical, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
March 22, 2023	P120003	iCast Covered Stent System	PRL	11	May 13, 2026	accessdata.fda.gov
October 9, 2020	P200023	Zilver Vena Venous Self-Expanding Stent	QAN	9	April 14, 2026	accessdata.fda.gov
December 31, 2018	P180001	Zenith Dissection Endovascular System	MIH	17	August 4, 2026	accessdata.fda.gov
September 15, 2015	P140016	ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT	MIH	18	August 4, 2026	accessdata.fda.gov
November 14, 2012	P100022	ZILVER PTX DRUG-ELUTING PERIPHERAL STENT	NIU	43	March 25, 2026	accessdata.fda.gov
January 14, 2011	P100028	FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM	NIN	4	October 8, 2014	accessdata.fda.gov
June 26, 2006	P050017	ZILVER VASCULAR STENT	NIO	25	April 14, 2026	accessdata.fda.gov
May 23, 2003	P020018	ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM	MIH	65	September 17, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 18, 2025	97615	Class I	Ongoing	Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W ZTA2-P-42-173 ZTA2-P-42-173-W ZTA2-P-42-	Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.	accessdata.fda.gov
April 1, 2024	94395	Class II	Ongoing	EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012	Devices may contain elevated levels of bacterial endotoxin.	accessdata.fda.gov
February 14, 2022	89689	Class III	Terminated	Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918	IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events	accessdata.fda.gov
February 25, 2019	82226	Class III	Terminated	Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via	Updates to the Instructions for Use.	accessdata.fda.gov
September 25, 2018	81238	Class II	Terminated	Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.	The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.	accessdata.fda.gov
March 22, 2017	77099	Class I	Terminated	Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissect	There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in patient death, and three cases resulted in reintervention.	accessdata.fda.gov
December 22, 2015	72965	Class II	Terminated	Zilver 518RX Vascular Stent with Rapid Exchange Delivery System	Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Failure of this joint during a procedure may result in a partial stent deployment. The clinical effect of a partial deployment may be a need for surgical intervention, or may result i	accessdata.fda.gov
September 26, 2014	69417	Class II	Terminated	Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to f	MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The recall has been initiated due to customer complaints that the protective caps were dislodged in the pouch. Further investigation disclosed potential dislodging of protective caps on the needle tips	accessdata.fda.gov

Compare with other makers

Updated May 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.