Not currently registered with FDA under this name
Kerrhawe SA
Orange, CA, United States. Named as applicant on 1 dental 510(k) clearance between 2012 and 2012. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12012–2012
- Markets registered in
- 81,322 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Kerrhawe SA 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 | Kerrhawe SA | 1 clearances | 2012–2012 | Below |
| Thailand | Thai FDA | Manufacturer | KERRHAWE SA | 1,197 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | KerrHawe SA | 79 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | KERRHAWE S.A. | 20 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | KerrHawe SAKerr Hawe · KerrHawe · +1 | 18 | 2005–2016 | Pure Global AI |
| Canada | Health Canada | Registration holder | KERRHAWE S.A. | 6 | 2002–2005 | Pure Global AI |
| Australia | TGA | Manufacturer | KerrHawe SA | 1 | 2009–2009 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | KERRHAWE SA | 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
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.