Cook Incorporated

Matched from indexed company URL: COOK INCORPORATED

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
1000393132	1000393132	COOK INCORPORATED	1	N	2026-01-01	6300 N. MATTHEWS DR. ELLETTSVILLE IN US 47429
3011050534	3011050534	Cook Incorporated	1	N	2026-01-01	300 E Elm St Canton IL US 61520

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
33145	2060156305	P100028	FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM	NIN	2011-01-14
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
33145	1724976240	K992070	COOK ULTRA QUIET VACUUM PUMP & REGULATOR	MQG	1999-10-27
33147	1907553243	K983642	COOK MINI-INCUBATOR	MQG	1999-02-01
173122	1907553243	K983642	COOK MINI-INCUBATOR	MQG	1999-02-01
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
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
173122	1671847807	K983591	INTRATUBAL TRANSFER SETS	MQF	1998-12-21
33145	1671847807	K983591	INTRATUBAL TRANSFER SETS	MQF	1998-12-21
33145	1080263481	K983590	GIFT CATHETER SET/S	MQF	1998-12-21
173122	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
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
173122	1876541818	K963565	MRI NEEDLES	FCG	1997-07-14
33145	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
173122	1828681605	K961933	CIRCLE NEPHROSTOMY CATHETER SET	LJE	1996-07-18
33145	1828681605	K961933	CIRCLE NEPHROSTOMY CATHETER SET	LJE	1996-07-18
173122	1883420177	K961904	AQ HYDROPHILIC DILATORS	KOE	1996-10-18
33145	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
33145	1220305407	K961446	AQ HYDROPHILIC STENT	FAD	1996-05-28
173122	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
33145	1282101168	K954398	INSEMI-CATH II	MFD	1995-12-19
173122	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
33147	1213561615	K940973	MULLAN GANGLION MICROCOMPRESSION SET	HAO	1995-09-29
33145	1213561615	K940973	MULLAN GANGLION MICROCOMPRESSION SET	HAO	1995-09-29
33145	1186947847	K940550	COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH	IWJ	1994-08-17
173122	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
173122	1360982363	K930608	ONIK-COHEN ACCESS SET	KOD	1993-07-09
33145	1360982363	K930608	ONIK-COHEN ACCESS SET	KOD	1993-07-09
173122	1769118945	K930135	SILICONE RECTAL BALLOON	FEN	1993-10-08
33145	1769118945	K930135	SILICONE RECTAL BALLOON	FEN	1993-10-08
173122	1973484203	K926559	PROACT BIOPSY NEEDLE ENCHANCEMENTS	FCG	1993-03-22
33145	1721381655	K923729	URETERAL CATHETER	EYB	1993-12-07
173122	1721381655	K923729	URETERAL CATHETER	EYB	1993-12-07
33147	1450660045	K923470	DISPOSABLE HOT BIOPSY FORCEPS	KGE	1993-04-21
33145	1649852610	K923436	ILLUMINATED URETERAL CATHETER	FCS	1993-03-05
173122	1398690309	K923031	ENDOSNARE	FDI	1993-06-07
33145	1398690309	K923031	ENDOSNARE	FDI	1993-06-07
33145	1182010716	K922354	BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET	GCC	1992-07-30
33145	1220957900	K921191	GIANTURCO-ROSCH BILIARY Z STENT	FGE	1992-05-15
33145	1092448126	K920891	ROADRUNNER(TM) WIRE GUIDE, MODIFICATION	DQX	1992-12-21
33145	1086515596	K920824	ROADRUNNER RLTF GUIDE WIRE	DQX	1992-10-16
33145	1403959802	K920823	WELTER SNARE RETRIEVER	DXE	1993-03-04
33147	1013882447	K920703	GASTROINTESTINAL FEEDING TUBE	KNT	1993-12-03
33147	1648763173	K920579	LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBE	KNT	1994-07-08
33145	1516149645	K915443	URODYNAMIC CATHETER	FAP	1992-02-19
173122	1516149645	K915443	URODYNAMIC CATHETER	FAP	1992-02-19
33145	1084747939	K915412	HYSTEROSCOPIC MYOMA SCREW	HHO	1992-05-18
33145	1814236194	K915388	LAPAROCOPIC MYOMA SCREW	HHO	1992-05-18
173122	1814236194	K915388	LAPAROCOPIC MYOMA SCREW	HHO	1992-05-18
33145	1912259541	K914555	WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI)	DRE	1992-01-03
173122	1352459509	K914150	JANSEN-ANDERSON INSEMINATION SET	MFD	1992-09-02
33145	1352459509	K914150	JANSEN-ANDERSON INSEMINATION SET	MFD	1992-09-02
33145	2041079758	K913468	ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY	LFJ	1994-03-24
33145	1515385312	K913350	VITAL-PORT(R) PETITE VASCULAR ACCESS SYSTEM	LJT	1991-08-09
33145	1335595391	K913258	DISPOSABLE INTROSSEOUS INFUSION NEEDLES	FMI	1992-03-04
33145	1042635987	K912465	VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM 1121	LJT	1991-07-30
33147	1042635987	K912465	VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM 1121	LJT	1991-07-30
33145	1337105002	K912423	VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112	LJT	1991-07-30
33147	2007085699	K912047	WILSON-COOK RUSSELL GASTROSTOMY KIT	KNT	1991-09-05

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
FAD	30	2019-04-23
DQX	23	2019-07-22
LJE	22	2020-01-29
KOD	21	2018-06-28
MQF	20	2019-05-17
DYB	19	2024-03-25
FGE	17	2018-05-01
DQY	15	2019-12-12
GEX	15	2018-07-30
KRA	14	2019-04-25
DQO	14	2019-03-22
KOB	14	2019-01-18
LKF	12	2019-03-29
DRE	11	2021-04-06
FOZ	11	2019-05-17
EZN	11	2018-07-17
LJT	11	2015-05-21
EYB	10	2019-08-05
KRD	10	2016-08-03
KNT	9	2019-10-11
KNW	9	2017-02-28
KOE	9	1997-10-10
FDX	8	2019-06-26
FBK	8	2017-07-28
KNA	8	2011-05-06
LJS	7	2016-10-07
FED	6	2019-05-29
BWC	6	2017-02-17
MQH	6	2016-01-08
OCY	6	2014-11-05
KNS	6	2005-08-05
HDR	6	1990-08-28
JOH	5	2019-12-12
LQR	5	2018-03-01
DTK	5	2016-07-22
MQG	5	1999-10-27
MMX	4	2023-05-16
ODC	4	2018-07-26
MOV	4	2018-07-12
BSR	4	2017-08-11