Manufacturer registered with FDA
Oscimed SA
La Chaux-De-Fonds, Switzerland. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 12024–2024
- Markets registered in
- 1029 registrations outside the US
- Establishments
- 1Switzerland
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name Oscimed SA as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Oscimed SA | 1 clearances | 2024–2024 | Below |
| European Union | EUDAMED | Manufacturer | Oscimed SA | 6 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | OSCIMED SAOscimed SA | 5 | 2013–2022 | Pure Global AI |
| Australia | TGA | Manufacturer | Oscimed SA | 4 | 2011–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | OSCIMED SAOscimed SA | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | OSCIMED SA | 4 | 2009–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | OSCIMED SA | 3 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | OSCIMED SA | 1 | 2024–2024 | Pure Global AI |
| China | NMPA | Registration holder | 奥斯迈德有限公司 Oscimed SA | 1 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | OSCIMED 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
Devices listed with FDA
What Oscimed SA currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Anti-snore Mouth Guard+ | 2024 |
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 |
|---|---|---|
| OSCIMED SAFDA reg. 9614473 | LA CHAUX-DE-FONDS, NE Neuchatel, Switzerland | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9038103). 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.