Registered with FDA
Cook Inc.
Bloomington, IN, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6714 registrations outside the US
- Establishments
- 1United States
Registered in 6 markets
Where regulators' registries name Cook Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Cook Inc. | 1 device types | — | Below |
| Taiwan | TFDA | Manufacturer | COOK INCORPORATEDCOOK INCORPORATED. · Cook Incorporated · +1 | 387 | 1989–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | COOK INCORPORATED | 142 | 1996–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | COOK INCORPORATEDCOOK, INC | 91 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Cook IncorporatedCook Inc. · COOK | 55 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | COOK INCORPORATED | 39 | 2006–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Cook Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Lister | — | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| COOK INCORPORATEDFDA reg. 1000393132 | ELLETTSVILLE, IN, United States | Contract sterilizer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1820334). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.