Cook Biotech Inc

FDA Filings

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

FDA Registration(s)
Registration Number1835959
FEI Number3002340648
NameCOOK BIOTECH, INC.
Owner & OperatorCOOK BIOTECH, INC.
Contact Address1425 INNOVATION PLACE --
West Lafayette IN 47906 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1425 INNOVATION PLACE
West Lafayette, IN 47906 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
COOK BIOTECH INCORPORATED
Biodesign C-AFP-0.6X9.52024-04-05
COOK BIOTECH INCORPORATED
Biodesign C-FP-0.72024-04-04
COOK BIOTECH INCORPORATED
Biodesign C-FP-0.42024-04-04
COOK BIOTECH INCORPORATED
Biodesign C-FP-0.22024-04-04
COOK BIOTECH INCORPORATED
Biodesign C-PRG-20D2022-06-10
COOK BIOTECH INCORPORATED
Biodesign C-RRG-2X202022-06-10
COOK BIOTECH INCORPORATED
Biodesign C-SLH-6H-5X302022-06-10
COOK BIOTECH INCORPORATED
Biodesign C-SLH-6H-2X302022-06-10
COOK BIOTECH INCORPORATED
Biodesign C-IHM-8X15-P2022-06-10
COOK BIOTECH INCORPORATED
Biodesign C-IHM-6X13-P2022-06-10
COOK BIOTECH INCORPORATED
Biodesign C-IHM-10X152022-06-10
COOK BIOTECH INCORPORATED
Biodesign C-BIG-10X402022-06-10
COOK BIOTECH INCORPORATED
OASIS 8213-3000-212022-03-31
COOK BIOTECH INCORPORATED
Fortify FTRG-7X20-S2022-03-31
COOK BIOTECH INCORPORATED
Fortify FTRG-7X10-S2022-03-31
COOK BIOTECH INCORPORATED
Fortify FTRG-4X7-S2022-03-31
COOK BIOTECH INCORPORATED
Fortify FTRG-1X10-S2022-03-31
COOK BIOTECH INCORPORATED
Fortify FTRG-7X202022-03-31
COOK BIOTECH INCORPORATED
Fortify FTRG-7X102022-03-31
COOK BIOTECH INCORPORATED
Fortify FTRG-4X72022-03-31
COOK BIOTECH INCORPORATED
Fortify FTRG-1X102022-03-31
COOK BIOTECH INCORPORATED
DynaMatrix Plus 10.501.10302022-03-31
COOK BIOTECH INCORPORATED
DynaMatrix Plus 10.501.10202022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-BIG-8X302022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-BIG-8X202022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-BIG-8X102022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-SLH-6H-7X102022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-PHR-7X102022-03-31
COOK BIOTECH INCORPORATED
DynaMatrix 10.401.30402022-03-31
COOK BIOTECH INCORPORATED
DynaMatrix 10.401.20302022-03-31
COOK BIOTECH INCORPORATED
DynaMatrix 10.401.15202022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-SLH-8H-20X302022-03-31
COOK BIOTECH INCORPORATED
Biodesign SLH-4-PR22022-03-31
COOK BIOTECH INCORPORATED
Biodesign SLH-4-PR12022-03-31
COOK BIOTECH INCORPORATED
OASIS 8213-3000-202022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-SLH-8H-13X222022-03-31
COOK BIOTECH INCORPORATED
Biodesign ENT-OTO-0.4-0.62022-03-31
COOK BIOTECH INCORPORATED
Biodesign ENT-OTO-0.6-0.92022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-IHM-8X15-P-B2022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-IHM-6X13-P-B2022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-IHM-10X15-B2022-03-31
COOK BIOTECH INCORPORATED
BIODESIGN ENT-OTO-5X52022-03-31
COOK BIOTECH INCORPORATED
BIODESIGN ENT-OTO-2.5X2.52022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-SLH-8H-20X202022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-SLH-8H-13X152022-03-31
COOK BIOTECH INCORPORATED
Biodesign ENT-TRG-7X102022-03-31
COOK BIOTECH INCORPORATED
Biodesign ENT-TRG-4X72022-03-31
COOK BIOTECH INCORPORATED
Biodesign ENT-TRG-2X32022-03-31
COOK BIOTECH INCORPORATED
Biodesign ENT-TRG-1X22022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-BRG-7X20-US2022-03-31
COOK BIOTECH INCORPORATED
Biodesign ENT-CBD-7X8.52022-03-31
COOK BIOTECH INCORPORATED
Biodesign ENT-CBD-5X52022-03-31
COOK BIOTECH INCORPORATED
Biodesign ENT-CBD-2.5X2.52022-03-31
COOK BIOTECH INCORPORATED
Biodesign ENT-CBD-1X22022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-DUR-2X32022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-PHR-7X10-U2022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-SLH-4S-2X32022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-DUR-7X202022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-DUR-7X102022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-DUR-4X72022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-SLH-8H-10X102022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-SLH-4S-1X102022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-SLH-1S-2X32022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-SLH-4S-4X72022-03-31
COOK BIOTECH INCORPORATED
Biodesign SLH-1S-7X102022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-SLH-1S-7X102022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-SLH-4S-7X102022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-SLH-4S-7X202022-03-31
COOK BIOTECH INCORPORATED
Biodesign C-SLH-6H-4X72022-03-29
COOK BIOTECH INCORPORATED
AxoGuard AG05402022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AG07202022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AG07402022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AG10202022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AG10402022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AGX1102022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AGX2102022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AGX3102022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AGX4102022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AGX5102022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AGX6102022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AGX7102022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AG05202022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AG03402022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AG03202022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AG02202022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AGX7152022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AGX6152022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AGX5152022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AGX4152022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AGX3152022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AGX2152022-03-23
COOK BIOTECH INCORPORATED
AxoGuard AGX1152022-03-23
COOK BIOTECH INCORPORATED
Biodesign C-SLH-6H-7X202022-03-17
COOK BIOTECH INCORPORATED
AxoGuard AGX7152021-12-08
COOK BIOTECH INCORPORATED
AxoGuard AGX6152021-12-08
COOK BIOTECH INCORPORATED
AxoGuard AGX5152021-12-08
COOK BIOTECH INCORPORATED
AxoGuard AGX4152021-12-08
COOK BIOTECH INCORPORATED
AxoGuard AGX3152021-12-08
COOK BIOTECH INCORPORATED
AxoGuard AGX2152021-12-08
COOK BIOTECH INCORPORATED
AxoGuard AGX1152021-12-08
Cook Biotech Incorporated
Biodesign Staple Line Reinforcement2020-07-13
Cook Biotech Incorporated
Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft2019-12-27
COOK BIOTECH, INC.
CorMatrix Cor Patch2018-12-10
Cook Biotech Incorporated
Biodesign Diaphragmatic Hernia Graft2018-03-13
COOK BIOTECH, INC.
tarSys2017-10-04
COOK BIOTECH, INC.
Biodesign Fistula Plug2017-07-12
Cook Biotech Incorporated
Biodesign Parastomal Hernia Repair Graft2017-07-10
Cook Biotech Incorporated
Biodesign Fistula Plug2017-06-21
COOK BIOTECH, INC.
Biodesign Staple Line Reinforcement2017-05-31
COOK BIOTECH, INC.
Biodesign Staple Line Reinforcement2017-05-31
Cook Biotech Incorporated
Biodesign Staple Line Reinforcement2017-04-28
COOK BIOTECH, INC.
AxoGuard Nerve Connector2017-03-01
COOK BIOTECH, INC.
DynaMatrix2017-03-01
COOK BIOTECH, INC.
DynaMatrix Plus2017-03-01
COOK BIOTECH INCORPORATED
DynaMatrix/Dynamatrix Plus2017-01-13
COOK BIOTECH INCORPORATED
AxoGuard Nerve Connector2016-10-31
COOK BIOTECH INCORPORATED
Flowable Wound Matrix2016-09-28
COOK BIOTECH, INC.
Biodesign Rectopexy Graft2016-06-20
COOK BIOTECH, INC.
Biodesign Plastic Surgery Matrix2016-06-20
COOK BIOTECH, INC.
Biodesign Anal Fistula Plug2016-06-20
COOK BIOTECH, INC.
Biodesign Tissue Graft2016-06-01
COOK BIOTECH, INC.
Biodesign Peyronie's Repair Graft2016-06-01
COOK BIOTECH, INC.
Biodesign Dural Graft2016-06-01
COOK BIOTECH, INC.
Biodesign Tissue Graft2016-06-01
COOK BIOTECH, INC.
Biodesign Peyronie's Repair Graft2016-06-01
COOK BIOTECH, INC.
Biodesign Dural Graft2016-06-01
Cook Biotech Incorporated
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug2016-05-26
COOK BIOTECH, INC.
Biodesign Otologic Repair Graft2016-05-16
COOK BIOTECH INCORPORATED
Biodesign Otologic Repair Graft2016-05-11
COOK BIOTECH INCORPORATED
Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft2016-04-29
COOK BIOTECH, INC.
TYKE2016-04-26
COOK BIOTECH, INC.
NRC Template2015-10-30
COOK BIOTECH, INC.
NRC Shield2015-10-30
COOK BIOTECH, INC.
Nipple Reconstruction Shield2015-10-20
COOK BIOTECH, INC.
Nipple Reconstruction Shield Extended2015-10-20
COOK BIOTECH, INC.
HaloShield Nipple Protector2015-10-20
COOK BIOTECH, INC.
HaloShield Nipple Protector Extended2015-10-20
COOK BIOTECH, INC.
Powder Extracellular Matrix2015-10-09
COOK BIOTECH, INC.
Oasis Micro Micronized Wound Matrix2015-10-09
COOK BIOTECH, INC.
Biodesign Otologic Repair Graft2015-10-09
COOK BIOTECH, INC.
Biodesign Inguinal Hernia Graft2015-10-09
Cook Biotech Incorporated
Cook ECM Powder2015-08-19
COOK BIOTECH, INC.
VasCure for Vascular Repair2014-08-27
COOK BIOTECH, INC.
ECM for Vascular Repair2014-08-27
COOK BIOTECH, INC.
Cormatrix ECM for Vascular Repair2014-08-27
COOK BIOTECH, INC.
VasCure for Carotid Repair2014-08-27
COOK BIOTECH, INC.
ECM for Carotid Repair2014-08-27
COOK BIOTECH, INC.
Cormatrix ECM for Carotid Repair2014-08-27
COOK BIOTECH, INC.
ProxiCor for Cardiac Tissue Repair2014-08-27
COOK BIOTECH, INC.
ECM for Cardiac Tissue Repair2014-08-27
COOK BIOTECH, INC.
Cormatrix ECM for Cardiac Tissue Repair2014-08-27
COOK BIOTECH, INC.
ProxiCor for Pericardial Closure2014-08-27
COOK BIOTECH, INC.
ECM for Pericardial Closure2014-08-27
COOK BIOTECH, INC.
Cormatrix ECM for Pericardial Closure2014-08-27
COOK BIOTECH, INC.
Biodesign Hernia Graft2014-08-05
COOK BIOTECH, INC.
Biodesign Hernia Graft2014-08-05
COOK BIOTECH, INC.
SIS HERNIA GRAFT2014-07-23
COOK BIOTECH, INC.
Biodesign Hiatal Hernia Graft2014-07-08
COOK BIOTECH, INC.
Biodesign Hiatal Hernia Graft2014-07-08
COOK BIOTECH, INC.
DIAPHRAGMATIC HERNIA GRAFT2014-06-20
COOK BIOTECH, INC.
Axoguard Nerve Protector2014-01-20
COOK BIOTECH INCORPORATED
NERVE CUFF2014-01-10
COOK BIOTECH, INC.
Biodesign Duraplasty Graft2013-10-23
COOK BIOTECH, INC.
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT2013-10-08
COOK BIOTECH INCORPORATED
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS2013-04-05
COOK BIOTECH, INC.
Biodesign Sinonasal Repair Graft2013-03-07
COOK BIOTECH, INC.
Biodesign ENT Tissue Repair Graft2013-03-07
COOK BIOTECH, INC.
Biodesign ENT Repair Graft2013-03-07
COOK BIOTECH, INC.
HYBRID GRAFT2012-04-02
COOK BIOTECH, INC.
Biodesign Nipple Reconstruction Cylinder2011-10-07
COOK BIOTECH, INC.
BIODESIGN NIPPLE RECONSTRUCTION CYLINDER2011-06-20
COOK BIOTECH, INC.
Biodesign Enterocutaneous Fistula Plug2009-10-08
COOK BIOTECH, INC.
SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG2009-02-27
COOK BIOTECH, INC.
DynaMatrix2008-11-06
COOK BIOTECH, INC.
DynaMatrix Plus Extracellular Membrane2008-11-06
COOK BIOTECH, INC.
DYNAMATRIX2008-10-02
COOK BIOTECH, INC.
SURGISIS BIODESIGN TISSUE GRAFT2008-03-21
COOK BIOTECH, INC.
Biodesign 4-Layer Tissue Graft2007-12-13
COOK BIOTECH, INC.
Biodesign 1-Layer Tissue Graft2007-12-13
COOK BIOTECH, INC.
Surgisis SLR Staple Line Reinforcem2007-12-11
COOK BIOTECH, INC.
Surgisis Biodesign Staple Line Rein2007-12-11
COOK BIOTECH, INC.
Biodesign Surgisis Staple Line Rein2007-12-11
COOK BIOTECH, INC.
Biodesign Staple Line Reinforcement2007-12-11
COOK BIOTECH, INC.
Biodesign Fistula Plug2007-12-11
COOK BIOTECH, INC.
Hernia Graft2007-12-11
COOK BIOTECH, INC.
Biodesign Anal Fistula Plug2007-12-11
COOK BIOTECH, INC.
Biodesign Plastic Surgery Matrix2007-12-11
COOK BIOTECH, INC.
Surgisis Biodesign Dural Graft2007-12-11
COOK BIOTECH, INC.
Durasis Dural Substitute2007-12-11
COOK BIOTECH, INC.
Biodesign Surgisis Dural Graft2007-12-11
COOK BIOTECH, INC.
Biodesign Dural Graft2007-12-11
COOK BIOTECH, INC.
AxoGuard Nerve Connector2007-12-11
COOK BIOTECH, INC.
Biodesign Rectopexy Graft2007-12-06
COOK BIOTECH, INC.
Biodesign Rectopexy Graft2007-12-06
COOK BIOTECH, INC.
Biodesign Rectopexy Graft2007-12-06
COOK BIOTECH, INC.
Biodesign Peyronie's Repair Graft2007-12-06
COOK BIOTECH, INC.
Oasis Wound Matrix2007-12-06
COOK BIOTECH, INC.
Oasis Ultra Tri-Layer Matrix2007-12-06
COOK BIOTECH, INC.
Oasis Burn Matrix2007-12-06
COOK BIOTECH, INC.
Biodesign Tension Free Sling2007-12-06
COOK BIOTECH, INC.
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT2007-10-17
COOK BIOTECH, INC.
SIS FACIAL CYLINDER, SIS FACIAL IMPLANT2007-04-05
COOK BIOTECH, INC.
SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT2006-10-13
COOK BIOTECH, INC.
SURGISIS, SURGISIS ES2006-10-13
COOK BIOTECH, INC.
SURGISIS RVP RECTO-VAGINAL FISTULA PLUG2006-10-10
COOK BIOTECH, INC.
SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-1002006-10-02
COOK BIOTECH, INC.
OASIS WOUND MATRIX2006-07-19
COOK BIOTECH, INC.
SURGISIS STAPLE LINE REINFORCEMENT II2005-09-23
COOK BIOTECH, INC.
SIS DERMAL AUGMENTATION STRAND2005-05-19
COOK BIOTECH, INC.
SIS FISTULA PLUG2005-03-09
COOK BIOTECH, INC.
SIS PLASTIC SURGERY MATRIX2004-02-18
COOK BIOTECH, INC.
DURASIS DURAL SUBSTITUTE2003-09-08
COOK BIOTECH, INC.
SURGISIS NERVE CUFF2003-05-15
COOK BIOTECH, INC.
SURGISIS STAPLE LINE REINFORCEMENT2002-08-23
COOK BIOTECH, INC.
SURGISIS GUIDED TISSUE REGENERATION MATRIX2002-06-10
COOK BIOTECH, INC.
SS MATRIX2002-05-30
COOK BIOTECH, INC.
STRATASIS SLING KIT2002-04-09
COOK BIOTECH, INC.
SURGISIS PERIPHERAL VASCULAR PATCH2000-12-27
COOK BIOTECH, INC.
SIS WOUND DRESSING II2000-01-06
COOK BIOTECH, INC.
SURGISIS SLING1999-09-23
COOK BIOTECH, INC.
SURGISIS1998-05-28
COOK BIOTECH, INC.
SIS WOUND DRESSING1998-04-30

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