Not currently registered with FDA under this name
Colmed, Ltd.
Mchenry, IL, United States. Named as applicant on 4 dental 510(k) clearances between 1980 and 1981. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 41980–1981
- Markets registered in
- 32 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 3 markets
Where regulators' registries name Colmed, Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Colmed, Ltd. | 4 clearances | 1980–1981 | Below |
| Colombia | INVIMA | Registration holder | COLMED LTDA | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | COLMED LTD | 1 | 1981–1981 | 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
510(k) clearances
Clearances on which FDA names Colmed, Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Jun 1981 | K811209 | JACOB WIRZ TRANSFIXATION PIN | ELS Endodontic Stabilizing Splint |
| 10 Feb 1981 | K810117 | HALOGEN HEADLIGHT SYSTEM | EBA Surgical Headlight Light |
| 28 May 1980 | K801208 | HOLLOW BASKET TITANIUM DENTAL IMPLANT | ELE Subperiosteal Implant |
| 14 May 1980 | K800762 | PS3 TITANIUM SCREW DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
Sources
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 of the most recent filing, which can be a US agent.