Not currently registered with FDA under this name
Biovision GmbH
Carlsbad, CA, United States. Named as applicant on 1 dental 510(k) clearance between 1998 and 1998. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 11998–1998
- Markets registered in
- 411 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 4 markets
Where regulators' registries name Biovision GmbH as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Biovision GmbH | 1 clearances | 1998–1998 | Below |
| Canada | Health Canada | Registration holder | BIOVISION AG | 5 | 2005–2005 | Pure Global AI |
| Colombia | INVIMA | Registration holder | BIOVISION AG | 3 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Biovision GmbH | 3 | — | 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
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.