Contract manufacturerCOOK BIOTECH, INC. (West Lafayette, IN)IndianaCardiovascularNeurologyOphthalmicClass II
COOK BIOTECH, INC.
Contract manufacturer ยท West Lafayette, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1835959 (openFDA record; or search FDA's registration database)
- FEI number
- 3002340648
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- COOK BIOTECH, INC. (FDA owner/operator no. 9031415)
- Registered address
- 1425 INNOVATION PLACE, West Lafayette, IN 47906
- Contract listings
- 10 device listings, 4 product codes, first listed Aug 27, 2014
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | Class II | Cardiovascular | Contract manufacturing | Aug 27, 2014 |
| JXI | Cuff, Nerve | Class II | Neurology | Contract manufacturing | Oct 6, 2017 |
| NXM | Prosthesis, Eyelid Spacer/Graft, Biologic | Class II | Ophthalmic | Contract manufacturing | Oct 4, 2017 |
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | Class II | Cardiovascular | Contract manufacturing | Dec 10, 2018 |