Not currently registered with FDA under this name
Industrias Medicas Sampedro S.A.S
La Estrella, Colombia. Named as applicant on 1 dental 510(k) clearance between 2021 and 2021. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12021–2021
- Markets registered in
- 378 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Industrias Medicas Sampedro S.A.S 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 | Industrias Medicas Sampedro S.A.S | 1 clearances | 2021–2021 | Below |
| Colombia | INVIMA | Registration holder | INDUSTRIAS MEDICAS SAMPEDRO S.A.S.INDUSTRIAS MÉDICAS SAMPEDRO S.A.S · INDUSTRIAS MEDICAS SAMPEDRO S.A.S · +2 | 73 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | INDUSTRIAS MEDICAS SAMPEDRO S.A.S. | 5 | 2022–2023 | 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 Industrias Medicas Sampedro S.A.S as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 19 May 2021 | K203282 | TECHFIT Patient-Specific Maxillofacial System | JEY Bone Plate |
Some of these clearances are listed with FDA today by another company: Acumed LLC (1).
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.