FDA.report

COOK MEDICAL LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30055801133005580113COOK MEDICAL LLC1Y2026-01-01400 DANIELS WAY Bloomington IN US 47404
30079657063007965706Cook Medical LLC1N2020-04-251025 Acuff Road Bloomington IN US 47404

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
253301095817176P200023Zilver Vena Venous Self-Expanding StentQAN2020-10-09
253301043292008P180001Zenith Dissection Endovascular SystemMIH2018-12-31
2318851043292008P180001Zenith Dissection Endovascular SystemMIH2018-12-31
253301416599544P140016ZENITH ALPHA THORACIC ENDOVASCULAR GRAFTMIH2015-09-15
2318851416599544P140016ZENITH ALPHA THORACIC ENDOVASCULAR GRAFTMIH2015-09-15
253301279636279P120003iCast Covered Stent SystemPRL2023-03-22
253302017190682P100028FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEMNIN2011-01-14
2318852017190682P100028FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEMNIN2011-01-14
253301319498062P100022ZILVER PTX DRUG-ELUTING PERIPHERAL STENTNIU2012-11-14
2318851319498062P100022ZILVER PTX DRUG-ELUTING PERIPHERAL STENTNIU2012-11-14
2318852011016599P070016ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEMMIH2008-05-21
253301576438382P050017ZILVER VASCULAR STENTNIO2006-06-26
2318851576438382P050017ZILVER VASCULAR STENTNIO2006-06-26
253301311178455P020018ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEMMIH2003-05-23
2318851311178455P020018ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEMMIH2003-05-23
253301214358233K992070COOK ULTRA QUIET VACUUM PUMP & REGULATORMQG1999-10-27
2318851214358233K992070COOK ULTRA QUIET VACUUM PUMP & REGULATORMQG1999-10-27
253301610823798K990130WILSON-COOK PANCREATIC WEDGE STENTFGE1999-02-12
2318851610823798K990130WILSON-COOK PANCREATIC WEDGE STENTFGE1999-02-12
253301209459895K983642COOK MINI-INCUBATORMQG1999-02-01
2318851209459895K983642COOK MINI-INCUBATORMQG1999-02-01
253301009369291K983609COOK TEST TUBE HEATERMQG1998-12-16
2318851009369291K983609COOK TEST TUBE HEATERMQG1998-12-16
253301769374774K983595TRANSMYOMETRIAL EMBRYO TRANSFER SETMQF1999-02-08
2318851769374774K983595TRANSMYOMETRIAL EMBRYO TRANSFER SETMQF1999-02-08
253302032850465K983593OVUM PICK-UP ASPIRATION NEEDLESMQE1999-01-21
2318852032850465K983593OVUM PICK-UP ASPIRATION NEEDLESMQE1999-01-21
2318851856244059K900923ZIMMON ENDOSCOPIC PANCREATIC STENTFGE1990-10-26
253301441806567K900035WILSON-COOK COLON DECOMPRESSION SETFEG1990-03-07
2318851441806567K900035WILSON-COOK COLON DECOMPRESSION SETFEG1990-03-07
253301583676979K896323WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETSFGE1990-04-09
2318851583676979K896323WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETSFGE1990-04-09
2318851177246474K851962ZIMMON BILIARY STENT SETFGE1985-12-17
253301902450261K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)FAJ2025-08-08
253301815147035K251951Single-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)FGB2025-12-16
253301721532441K250132Ureteral Access SheathFED2025-09-05
253301596285713K242419018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterLIT2024-11-15
253301445576650K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)FCG2024-07-29
253301825811075K233680Celect 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 FilterDTK2024-01-18
253301097097668K233294Automatic Biopsy Needle BAM, Semi-Automatic Needle BIMKNW2024-06-18
253301358904860K233079Zimmon® 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)FGE2024-06-14
253301236117968K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)FCG2023-05-30
253301806551968K222462Semi-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)KNW2023-01-20
253301548873002K221482Esophageal TTS StentESW2022-06-22
253302061336019K221158Single-Use Video Flexible Ureterorenoscope SystemFGB2023-03-06
253301805030285K220785Clean Connecting TubeOCX2022-09-27
253301601253353K220210Disposable Endoscopy Adapter SetODC2022-06-17
253301041735376K220137Lunderquist Extra Stiff Wire GuideDQX2022-02-17
253301142292838K213946Compass BDS Biliary StentFGE2022-05-09
253301562012840K211802GoBack Crossing CatheterPDU2022-03-01
253301215258588K200234Surgical laser fibersGEX2020-02-25
253301476392993K191502Heraeus Peripheral GuidewireDQX2019-11-26
253302048764721K182980Zilver 518 Biliary Stent, Zilver 635 Biliary StentFGE2018-11-16
2318852048764721K182980Zilver 518 Biliary Stent, Zilver 635 Biliary StentFGE2018-11-16
253302041898958K180868Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage SetFGE2018-07-06
2318852041898958K180868Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage SetFGE2018-07-06
253301110312359K180007018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterLIT2018-04-19
253301411882798K173431Towako Transmyometrial Embryo Transfer SetMQF2018-05-18
2318851411882798K173431Towako Transmyometrial Embryo Transfer SetMQF2018-05-18
253301921354956K172557Gunther 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 ApproachDTK2017-11-20
2318851921354956K172557Gunther 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 ApproachDTK2017-11-20
253301918369459K171712Cook 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 ApproachDTK2017-08-07
2318851918369459K171712Cook 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 ApproachDTK2017-08-07
253301479207953K171625Single Lumen Ovum Aspiration NeedlesMQE2018-01-12
2318851479207953K171625Single Lumen Ovum Aspiration NeedlesMQE2018-01-12
253301325746320K171623Nasal Pancreatic Drainage SetFGE2017-07-31
2318851325746320K171623Nasal Pancreatic Drainage SetFGE2017-07-31
253301223538114K17161914Fr Colon Decompression Set, Macon Colon Decompression SetFEG2017-08-01
2318851223538114K17161914Fr Colon Decompression Set, Macon Colon Decompression SetFEG2017-08-01
253301726938019K171611Double Lumen Ovum Aspiration NeedlesMQE2017-12-15
2318851726938019K171611Double Lumen Ovum Aspiration NeedlesMQE2017-12-15
253301198648448K171513Lunderquist Extra Stiff Wire GuideDQX2017-12-07
2318851198648448K171513Lunderquist Extra Stiff Wire GuideDQX2017-12-07
253301547126624K171347Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit ConnectionPIF2017-06-06
253301542805497K171251014 Hydrophilic Coated PTA Balloon Dilatation CatheterLIT2017-09-08
253301245816183K170257Sydney IVF Culture OilMQL2017-02-24
2318851245816183K170257Sydney IVF Culture OilMQL2017-02-24
253301137908320K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredMUM2017-05-04
2318851137908320K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredMUM2017-05-04
253301333152450K163018Zilver 635 Biliary StentFGE2016-12-23
2318851333152450K163018Zilver 635 Biliary StentFGE2016-12-23
253302043752225K162717Evolution Esophageal Stent System – Partially CoveredESW2016-12-21
2318852043752225K162717Evolution Esophageal Stent System – Partially CoveredESW2016-12-21
253301115878342K161813Frova Intubating IntroducerBTR2017-05-19
2318851115878342K161813Frova Intubating IntroducerBTR2017-05-19
253301286936550K161408Compass Cast and MAPDRS2016-11-22
253301960727451K160814Sydney IVF Sperm Cryopreservation BufferMQL2016-04-22
2318851960727451K160814Sydney IVF Sperm Cryopreservation BufferMQL2016-04-22
253301947560978K160753COOK Vacuum PumpMQG2017-06-13
2318851947560978K160753COOK Vacuum PumpMQG2017-06-13
253301191091625K160513Quanta System Surgical Laser fibersGEX2016-03-18
2318851746774906K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy NeedleFCG2016-03-21
253301141752990K153478Sydney IVF Gamete BufferMQL2016-08-15
2318851141752990K153478Sydney IVF Gamete BufferMQL2016-08-15
253301252909230K153290Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst MediumMQL2016-01-27
2318851252909230K153290Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst MediumMQL2016-01-27
253301380425663K152904SYDNEY IVF EMBRYO BIOPSY MEDIUMMQL2015-12-03
2318851380425663K152904SYDNEY IVF EMBRYO BIOPSY MEDIUMMQL2015-12-03
253301839688986K152782SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENTMQL2015-12-21
2318851839688986K152782SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENTMQL2015-12-21
253301387308101K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing KitMQL2016-05-06
2318851387308101K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing KitMQL2016-05-06
253301547840902K152682Sydney IVF Cryopreservation Kit, Sydney IVF Thawing KitMQL2016-05-05
2318851547840902K152682Sydney IVF Cryopreservation Kit, Sydney IVF Thawing KitMQL2016-05-05
253301277914143K152440Sydney IVF PVPMQL2015-09-23
2318851277914143K152440Sydney IVF PVPMQL2015-09-23
253301009561686K151976Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeFAS2016-06-27
253301529374125K151367Sydney IVF HyaluronidaseMQL2016-01-27
2318851529374125K151367Sydney IVF HyaluronidaseMQL2016-01-27
253301156202357K150964MReye Flipper Detachable Embolization Coil and Delivery SystemKRD2015-12-18
2318851156202357K150964MReye Flipper Detachable Embolization Coil and Delivery SystemKRD2015-12-18
253301377886462K143724COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming KitMQL2015-08-27
2318851377886462K143724COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming KitMQL2015-08-27
2318852008699955K142688Echotip Procore HD Ultrasound Biopsy NeedleFCG2014-12-19
253301484156301K141365OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMENMQE2014-08-07
2318851484156301K141365OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMENMQE2014-08-07
253301400629311K140406DESTINO TWIST, STEERABLE GUIDING SHEATHDYB2014-04-17
253301208165144K131473(QUANTA SYSTEM) SURGICAL LASER FIBERSGEX2013-10-24
253301855286428K130611ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBEKNT2013-12-19
253301274745877K121430EVOLUTION BILIARY STENT SYSTEMFGE2013-03-01

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MQL422017-02-24
FGE212024-06-14
FCG82024-07-29
MQE82018-01-12
MQG82017-06-13
ESW62022-06-22
DTK52024-01-18
MIH52018-12-31
DQX42022-02-17
MQF42018-05-18
FEG42017-08-01
KNS42005-04-22
LIT32024-11-15
GEX32020-02-25
FGB22025-12-16
KNW22024-06-18
QIJ22019-11-20
BTR22017-05-19
MUM22017-05-04
KRD22015-12-18
MIH 22015-09-15
NIU22012-11-14
NIN 22011-01-14
FAD22007-05-08
FER22006-09-06
NIO22006-06-26
BSP22003-05-27
FED12025-09-05
FAJ12025-08-08
QUD12023-02-24
OCX12022-09-27
ODC12022-06-17
PDU12022-03-01
QAN 12020-10-09
PIF12017-06-06
DRS12016-11-22
FAS12016-06-27
DYB12014-04-17
KNT12013-12-19
FDI12005-03-31

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 ...

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