Data / Medical devices / United Kingdom / Signifier Medical Technologies Limited
Signifier Medical Technologies Limited: FDA-registered device maker in Manchester, United Kingdom, 3 510(k) clearances
Signifier Medical Technologies Limited is registered with the FDA (registration 3018192374) in Manchester, United Kingdom. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated May 16, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3018192374
- Address
- Pall Mall, 1 Pollen Sq, 59 King Street, Manchester, United Kingdom, M2 4PD
- Owner or operator
- Signifier Medical Technologies Limited (10080665)
- Roles
- Manufacturer
- First device listed
- February 18, 2021
- Registered through
- 2026
- Brand names listed
- eXciteOSA, eXciteOSA 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)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea | QNO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 16, 2024 | K240328 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | QNO | Substantially Equivalent | Signifier Medical Technologies, Ltd. | accessdata.fda.gov |
| January 18, 2023 | K223446 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | QNO | Substantially Equivalent | Signifier Medical Technologies, Ltd. | accessdata.fda.gov |
| February 5, 2021 | DEN200018 | eXciteOSA with remote and eXciteOSA without remote | QNO | Unknown | Signifier Medical Technologies | accessdata.fda.gov |
Compare with other makers
Updated May 16, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.