BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COOK BIOTECH, INC.

    Reg #: 1835959 · FEI: 3002340648 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    61
    Establishment Types
    2
    Classifications
    19

    Registration Details

    Registration Name
    COOK BIOTECH, INC.
    Registration Number
    1835959
    FEI Number
    3002340648
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1425 INNOVATION PLACE
    City
    West Lafayette
    State
    IN
    ZIP
    47906
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050337

    Owner / Operator

    Firm Name
    COOK BIOTECH, INC.
    Operator Number
    9031415
    Address
    1425 INNOVATION PLACE, --
    City
    West Lafayette
    State
    IN
    Postal Code
    47906
    Country
    US
    Correspondent
    Monica A Bravo

    Products

    Device Name Product Code
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
    Mesh, Surgical FTM
    Barrier, Animal Source, Intraoral NPL
    Dura Substitute GXQ
    Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator PAG
    Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed PAJ
    Shield, Nipple HFS
    Mesh, Surgical, Collagen, Large Abdominal Wall Defects OXK
    Cuff, Nerve JXI
    Wound Dressing With Animal-Derived Material(S) KGN
    Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) KHJ
    Template HWT
    Catheter, Irrigation GBX
    Mesh, Surgical, Collagen, Diaphragmatic Hernia OWV
    Mesh, Surgical, Collagen, Fistula OXN
    Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery OXH
    Mesh, Surgical, Polymeric FTL
    Intracardiac Patch Or Pledget, Biologically Derived PSQ
    Prosthesis, Eyelid Spacer/Graft, Biologic NXM

    Proprietary Names

    Cormatrix ECM for Pericardial Closure ECM for Pericardial Closure ProxiCor for Pericardial Closure Biodesign Anal Fistula Plug DynaMatrix Plus Extracellular Membrane DynaMatrix Biodesign Peyronie's Repair Graft Biodesign Tissue Graft Biodesign Dural Graft Biodesign 4-Layer Tissue Graft Biodesign 1-Layer Tissue Graft durasis DURAL GRAFT Biodesign Nipple Reconstruction Cylinder Biodesign Rectopexy Graft NRC Shield Biodesign Hernia Graft Biodesign Plastic Surgery Matrix Cormatrix ECM for Cardiac Tissue Repair ProxiCor for Cardiac Tissue Repair ECM for Cardiac Tissue Repair Fortify Flowable Extracellular Matrix Flowable Wound Matrix Biodesign Otologic Repair Graft Axoguard Nerve Protector NRC Template AxoGuard Nerve Connector Nipple Reconstruction Shield Extended Nipple Reconstruction Shield HaloShield Nipple Protector Extended HaloShield Nipple Protector Biodesign Enterocutaneous Fistula Plug Powder Extracellular Matrix Oasis Micro Micronized Wound Matrix Biodesign Duraplasty Graft Biodesign Otologic Butterfly Graft Biodesign Hiatal Hernia Graft Durasis Dural Substitute Surgisis Biodesign Dural Graft Biodesign Surgisis Dural Graft Cormatrix ECM for Vascular Repair VasCure for Vascular Repair ECM for Vascular Repair Axoguard HA+ Nerve Protector TYKE Oasis Wound Matrix Oasis Ultra Tri-Layer Matrix Oasis Burn Matrix Oasis Extracellular Matrix Biodesign Fistula Plug Cormatrix ECM for Carotid Repair ECM for Carotid Repair VasCure for Carotid Repair DynaMatrix Plus Biodesign Inguinal Hernia Graft Biodesign Sinonasal Repair Graft Biodesign ENT Tissue Repair Graft Biodesign ENT Repair Graft Fortify TRG Tissue Repair Graft Hernia Graft CorMatrix Cor Patch tarSys

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device