Registered with FDA
Orthomed Inc
Tigard, OR, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6505 registrations outside the US
- Establishments
- 1United States
Registered in 6 markets
Where regulators' registries name Orthomed 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 | Orthomed Inc | 3 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | OrthoMed, Inc. | 496 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | ORTHOMED S.A.OrthoMed, Inc. | 5 | 2004–2022 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ORTHOMED, INC | 2 | 2015–2015 | Pure Global AI |
| Australia | TGA | Manufacturer | Orthomed Inc | 1 | 2017–2017 | Pure Global AI |
| Israel | AMAR | Manufacturer | Orthomed Inc | 1 | — | 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 Orthomed 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 |
|---|---|---|---|---|
| Operative PliersEJY · Class 1 | Dental hand instruments | Lister | ORTHOMED INC | 2019 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Lister | ORTHOMED INC | 2019 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Lister | ORTHOMED INC | 2019 |
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 |
|---|---|---|
| ORTHO-MED, INC.FDA reg. 3019455 | Tigard, OR, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 3019455). 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.