Cook Incorporated

Matched from indexed company URL: Cook, Inc.

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1820334	1820334	Cook Incorporated	1	Y	2026-01-01	750 DANIELS WAY Bloomington IN US 47404
1825146	1825146	Cook Incorporated	1	N	2026-01-01	1100 W Morgan St Spencer IN US 47460
1835959	3002340648	COOK BIOTECH, INC.	1	N	2026-01-01	1425 INNOVATION PLACE West Lafayette IN US 47906
2522007	2522007	COOK VANDERGRIFT INC.	1	N	2026-01-01	1186 Montgomery Lane Vandergrift PA US 15690
1000393132	1000393132	COOK INCORPORATED	1	N	2026-01-01	6300 N. MATTHEWS DR. ELLETTSVILLE IN US 47429
3005580113	3005580113	COOK MEDICAL LLC	1	Y	2026-01-01	400 DANIELS WAY Bloomington IN US 47404
3011050534	3011050534	Cook Incorporated	1	N	2026-01-01	300 E Elm St Canton IL US 61520
3012766489	3012766489	COOK, INC.	1	N	2026-01-01	1700 N Curry Pike Bloomington IN US 47404
3016054554	3016054554	COOK CAPITAL EQUIPMENT	1	Y	2026-01-01	750 N Daniels Way Bloomington IN US 47404
3004594307	3004594307	COOKGAS LLC	1	N	2020-04-25	1101 Lucas Ave Ste 200 Saint Louis MO US 63101
3007965706	3007965706	Cook Medical LLC	1	N	2020-04-25	1025 Acuff Road Bloomington IN US 47404
3013104519	3013104519	COOK BIODEVICE LLC	1	N	2020-04-25	500 W SIMPSON CHAPEL RD Bloomington IN US 47404

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID	Product	Phone	Email
10827002256702	Solus - Solus, Double Pigtail Stent with Introducer	+1(812)330-5494	sharedservices@cookmedical.com
10827002256719	Solus - Solus, Double Pigtail Stent with Introducer	+1(812)330-5494	sharedservices@cookmedical.com
10827002256726	Solus - Solus, Double Pigtail Stent with Introducer	+1(812)330-5494	sharedservices@cookmedical.com
10827002256733	Solus - Solus, Double Pigtail Stent with Introducer	+1(812)330-5494	sharedservices@cookmedical.com

cookmedical.com

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
33145	1501604450	P990008	COOK MBC PTCA BALLOON DILATATION CATHETER	LOX	1999-09-27
33145	1893333660	P910030	Gianturco-roubin Coronary Flex-stent(tm)		1993-02-08
33145	1741985041	P900007	COOK CHORIONIC VILLUS SAMPLING SET	LLX	1994-09-30
173122	1741985041	P900007	COOK CHORIONIC VILLUS SAMPLING SET	LLX	1994-09-30
33145	1756839559	P880078	Vh8500 Hyperthermia Treatment System		1989-10-17
33145	1626249894	P850049	Cook Bird's Nest Vena Cava Filter		1989-04-26
25330	1095817176	P200023	Zilver Vena Venous Self-Expanding Stent	QAN	2020-10-09
231885	1043292008	P180001	Zenith Dissection Endovascular System	MIH	2018-12-31
25330	1043292008	P180001	Zenith Dissection Endovascular System	MIH	2018-12-31
25330	1416599544	P140016	ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT	MIH	2015-09-15
231885	1416599544	P140016	ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT	MIH	2015-09-15
25330	1279636279	P120003
231885	2017190682	P100028	FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM	NIN	2011-01-14
25330	2017190682	P100028	FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM	NIN	2011-01-14
33145	2060156305	P100028	FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM	NIN	2011-01-14
231885	1319498062	P100022	ZILVER PTX DRUG-ELUTING PERIPHERAL STENT	NIU	2012-11-14
25330	1319498062	P100022	ZILVER PTX DRUG-ELUTING PERIPHERAL STENT	NIU	2012-11-14
231885	2011016599	P070016	ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM	MIH	2008-05-21
25330	1576438382	P050017	ZILVER VASCULAR STENT	NIO	2006-06-26
231885	1576438382	P050017	ZILVER VASCULAR STENT	NIO	2006-06-26
25330	1311178455	P020018	ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM	MIH	2003-05-23
231885	1311178455	P020018	ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM	MIH	2003-05-23
33145	1809392638	P020018	ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM	MIH	2003-05-23
33145	2038825888	K993455	FLIPPER DETACHABLE EMBOLIZATION COIL	KRD	2000-01-11
33145	1431884420	K992198	URETHANE PICC LINE MODEL UPICS-	FOZ	1999-08-27
17292	1385045820	K992159	SURGISIS SLING	PAG	1999-09-23
25330	1214358233	K992070	COOK ULTRA QUIET VACUUM PUMP & REGULATOR	MQG	1999-10-27
231885	1214358233	K992070	COOK ULTRA QUIET VACUUM PUMP & REGULATOR	MQG	1999-10-27
33145	1724976240	K992070	COOK ULTRA QUIET VACUUM PUMP & REGULATOR	MQG	1999-10-27
25330	1610823798	K990130	WILSON-COOK PANCREATIC WEDGE STENT	FGE	1999-02-12
231885	1610823798	K990130	WILSON-COOK PANCREATIC WEDGE STENT	FGE	1999-02-12
25330	1209459895	K983642	COOK MINI-INCUBATOR	MQG	1999-02-01
231885	1209459895	K983642	COOK MINI-INCUBATOR	MQG	1999-02-01
33147	1907553243	K983642	COOK MINI-INCUBATOR	MQG	1999-02-01
173122	1907553243	K983642	COOK MINI-INCUBATOR	MQG	1999-02-01
25330	1009369291	K983609	COOK TEST TUBE HEATER	MQG	1998-12-16
231885	1009369291	K983609	COOK TEST TUBE HEATER	MQG	1998-12-16
33145	1870051364	K983609	COOK TEST TUBE HEATER	MQG	1998-12-16
173122	1870051364	K983609	COOK TEST TUBE HEATER	MQG	1998-12-16
173122	1688252758	K983596	INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING	MQH	1999-02-05
33145	1688252758	K983596	INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING	MQH	1999-02-05
231885	1769374774	K983595	TRANSMYOMETRIAL EMBRYO TRANSFER SET	MQF	1999-02-08
25330	1769374774	K983595	TRANSMYOMETRIAL EMBRYO TRANSFER SET	MQF	1999-02-08
33145	1948609250	K983595	TRANSMYOMETRIAL EMBRYO TRANSFER SET	MQF	1999-02-08
33145	1476181147	K983594	EMBRYO TRANSFER CATHETERS/SETS	MQF	1998-12-21
173122	1476181147	K983594	EMBRYO TRANSFER CATHETERS/SETS	MQF	1998-12-21
33145	1471517457	K983593	OVUM PICK-UP ASPIRATION NEEDLES	MQE	1999-01-21
231885	2032850465	K983593	OVUM PICK-UP ASPIRATION NEEDLES	MQE	1999-01-21
25330	2032850465	K983593	OVUM PICK-UP ASPIRATION NEEDLES	MQE	1999-01-21
33145	1671847807	K983591	INTRATUBAL TRANSFER SETS	MQF	1998-12-21
173122	1671847807	K983591	INTRATUBAL TRANSFER SETS	MQF	1998-12-21
173122	1080263481	K983590	GIFT CATHETER SET/S	MQF	1998-12-21
33145	1080263481	K983590	GIFT CATHETER SET/S	MQF	1998-12-21
33145	1017102460	K982500	CHAIT CECOSTOMY CATHETER	KNT	1999-01-27
33145	2023073423	K982333	MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY	MSD	1999-02-12
33145	1167148497	K980431	SURGISIS	FTM	1998-05-28
17292	1240265518	K980431	SURGISIS	FTM	1998-05-28
33145	1483507917	K974357	UTERINE MANIPULATOR/INJECTOR	LKF	1998-02-02
33145	1800358782	K973565	QUICK-CARE BIOPSY NEEDLE	KNW	1997-11-03
33145	1142229225	K973170	SIS WOUND DRESSING	KGN	1998-04-30
33147	1142229225	K973170	SIS WOUND DRESSING	KGN	1998-04-30
33145	1091115014	K972964	ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE	KOE	1997-10-10
33145	1650148799	K970690	LOCKING STYLET 2	DQX	1997-05-20
33145	1493298352	K964001	SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM	ITX	1998-04-17
38278	1577491396	K964001	SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM	ITX	1998-04-17
33145	1876541818	K963565	MRI NEEDLES	FCG	1997-07-14
173122	1876541818	K963565	MRI NEEDLES	FCG	1997-07-14
33145	1027517666	K962761	REIGEL TUNNELING DEVICE	GYK	1996-10-11
33145	1991949161	K962097	VENTRICULAR CATHETER SET	JXG	1996-08-29
33145	1668118123	K962004	AQ HYDROPHILIC UROLOGICAL CATHETERS	EYB	1996-06-11
173122	1668118123	K962004	AQ HYDROPHILIC UROLOGICAL CATHETERS	EYB	1996-06-11
33145	1389668065	K961992	NEEDLE'S EYE SNARE	DXE	1996-12-27
38278	1756235899	K961992	NEEDLE'S EYE SNARE	DXE	1996-12-27
33145	1828681605	K961933	CIRCLE NEPHROSTOMY CATHETER SET	LJE	1996-07-18
173122	1828681605	K961933	CIRCLE NEPHROSTOMY CATHETER SET	LJE	1996-07-18
33145	1883420177	K961904	AQ HYDROPHILIC DILATORS	KOE	1996-10-18
173122	1883420177	K961904	AQ HYDROPHILIC DILATORS	KOE	1996-10-18
33147	1268502466	K961897	WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE	FCG	1997-01-29
33145	1667114554	K961668	MICROFERRET CATHETER	KRA	1996-11-04
173122	1220305407	K961446	AQ HYDROPHILIC STENT	FAD	1996-05-28
33145	1220305407	K961446	AQ HYDROPHILIC STENT	FAD	1996-05-28
33145	1626742533	K961371	SUBCUTANEOUS URINARY DIVERSON STENT SET	FAD	1996-07-24
173122	1626742533	K961371	SUBCUTANEOUS URINARY DIVERSON STENT SET	FAD	1996-07-24
33147	1192672623	K960415	WILSON-COOK BALLOON INFLATION DEVICE	KNT	1996-04-26
173122	2037768893	K960263	CERVICAL MUCOUS ASPIRATION CATHETER	HFC	1996-08-29
33145	2037768893	K960263	CERVICAL MUCOUS ASPIRATION CATHETER	HFC	1996-08-29
33145	1095833520	K955508	ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET	LKF	1996-02-26
173122	1282101168	K954398	INSEMI-CATH II	MFD	1995-12-19
33145	1282101168	K954398	INSEMI-CATH II	MFD	1995-12-19
33145	1822628913	K953522	USCI IDEAL PTCA KIT	MAV	1996-04-17
173122	1404579651	K952527	BALLOON UTERINE STENT	KNA	1996-01-02
33145	1404579651	K952527	BALLOON UTERINE STENT	KNA	1996-01-02
173122	1433519986	K952513	LESE STENTS SETS	FAD	1996-06-10
33145	1433519986	K952513	LESE STENTS SETS	FAD	1996-06-10
33145	1884349146	K951106	SILICONE FOLEY CATHETER	EZL	1995-05-25
173122	1884349146	K951106	SILICONE FOLEY CATHETER	EZL	1995-05-25
33145	1743879739	K951077	VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM	LJT	1995-07-31
33145	1160338811	K951076	VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM	LJT	1995-06-13
33145	1917745270	K950118	ABRM CATHETER	FOZ	1996-02-08
33145	1967700155	K945201	COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT	ESW	1995-01-04
33147	1079080452	K941305	WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE	FBK	1994-06-02
33145	1178569581	K941256	QUICK CORE II	KNW	1994-07-13
33145	1960760845	K941092	MURDOCH LAPAROSCOPE LENS CLEANER	GCJ	1994-04-11
33145	1213561615	K940973	MULLAN GANGLION MICROCOMPRESSION SET	HAO	1995-09-29
33147	1213561615	K940973	MULLAN GANGLION MICROCOMPRESSION SET	HAO	1995-09-29
173122	1186947847	K940550	COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH	IWJ	1994-08-17
33145	1186947847	K940550	COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH	IWJ	1994-08-17
33145	1462064473	K940189	COIL POSITIONER SET	KRD	1994-11-28
173122	1538229744	K935874	COOK COAGULATOR PROBE	GEI	1994-03-07
33145	1538229744	K935874	COOK COAGULATOR PROBE	GEI	1994-03-07
33147	1579443067	K935094	BALLOON DILATION CATHETER	FGE	1995-01-24
33145	1913934582	K932114	TUBAL LUMEN SUPPORT	HFJ	1994-09-27
33145	1821055739	K931586	VITAL-PORT MINI VASCULAR ACCESS SYSTEM	DWF	1993-09-27
173122	1887663178	K931476	NOVY CORNUAL CANNULATION SET	MOV	1995-07-28
33145	1887663178	K931476	NOVY CORNUAL CANNULATION SET	MOV	1995-07-28
173122	1167474354	K931195	PERCUTANEOUS DRAINAGE LOOP CATHETER SET	KOD	1993-12-22
33145	1167474354	K931195	PERCUTANEOUS DRAINAGE LOOP CATHETER SET	KOD	1993-12-22
33145	1903114595	K930900	COOK ASPIRATION UNIT	JCX	1993-07-22
33145	1360982363	K930608	ONIK-COHEN ACCESS SET	KOD	1993-07-09
173122	1360982363	K930608	ONIK-COHEN ACCESS SET	KOD	1993-07-09

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
MQL	42	2017-02-24
FGE	38	2024-06-14
FAD	32	2019-04-23
DQX	27	2022-02-17
MQF	24	2019-05-17
LJE	22	2020-01-29
KOD	21	2018-06-28
DYB	20	2024-03-25
GEX	18	2020-02-25
DQY	15	2019-12-12
DQO	15	2019-03-22
DRE	14	2021-04-06
KRA	14	2019-04-25
KOB	14	2019-01-18
FTM	14	2017-06-21
MQG	13	2017-06-13
FCG	12	2024-07-29
LKF	12	2019-03-29
KRD	12	2016-08-03
KNW	11	2024-06-18
FOZ	11	2019-05-17
EZN	11	2018-07-17
LJT	11	2015-05-21
DTK	10	2024-01-18
KNT	10	2019-10-11
EYB	10	2019-08-05
MQH	10	2016-01-08
KNS	10	2005-08-05
KOE	10	2004-03-03
MQE	9	2018-01-12
FBK	9	2017-07-28
FDX	8	2019-06-26
KNA	8	2011-05-06
FED	7	2025-09-05
LIT	7	2024-11-15
ESW	7	2022-06-22
LJS	7	2016-10-07
MIH	6	2018-12-31
ITX	6	2018-07-17
BWC	6	2017-02-17

NDC

Oxygen

Cook Children's Home Health

Oxygen

PMA

Zenith Alpha Thoracic Endovascular Graft

2022-04-14

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 ...

Zilver Vascular Stent

2022-04-04

Cook Ireland, Ltd.o'halloran Roadnational Technology Parklimerick PMA NumberP050017 Supplement NumberS019 Date Received03/07/2022 Decision Date04/04/2022 Product Code NIO Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...

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PMN

Bakri Essential Postpartum Balloon

2022-10-28

Cook Incorporated

EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle

2021-05-20

Cook Ireland Ltd.

Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray,

2019-12-12

Cook Incorporated

Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set And Soft-Pass Embryo Mock Transfer Catheter Set With Echogenic Tip)

2019-05-17

Cook Incorporated

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Applications

074881

COOK IMAGING

200 records. Showing 1-40. Next