Manufacturer registered with FDA
Signifier Medical Technologies Limited
Manchester, United Kingdom. Lists 1 dental device type with FDA across 2 registered establishments, and holds 3 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 7
- 510(k) clearances
- 32021–2024
- Markets registered in
- 55 registrations outside the US
- Establishments
- 2United Kingdom, United States
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Signifier Medical Technologies Limited 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 | Signifier Medical Technologies Limited | 3 clearances | 2021–2024 | Below |
| Canada | Health Canada | Registration holder | SIGNIFIER MEDICAL TECHNOLOGIES LIMITED | 2 | 2017–2020 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Signifier Medical Technologies Limited | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Signifier Medical Technologies Limited | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Signifier Medical Technologies Limited | 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 Signifier Medical Technologies Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep ApneaQNO · Class 2 | — | Maker | eXciteOSAeXciteOSA control unit only pack (warranty replacement) (17000)eXciteOSA full system - with remote control (18010)eXciteOSA mouthpiece replacement (16000)eXciteOSA remote control only (14001)eXciteOSA remote control only (warranty replacement) (14000)eXciteOSA starter pack - without remote control (13010) | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Signifier Medical Technologies Limited as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 May 2024 | K240328 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | QNO Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea |
| 18 Jan 2023 | K223446 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | QNO Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea |
| 5 Feb 2021 | DEN200018 | eXciteOSA with remote and eXciteOSA without remote | QNO Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SIGNIFIER MEDICAL TECHNOLOGIES LIMITEDFDA reg. 3018192374 | Manchester, United Kingdom | Manufacturer |
| SIGNIFIER MEDICAL TECHNOLOGIES LLCFDA reg. 3017737771 | Wake Forest, NC, United States | Complaint file establishment |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10080665). 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.