Signifier Medical Technologies Limited
Wake Forest, NC, US
SIGNIFIER MEDICAL TECHNOLOGIES LIMITED appears in FDA device records in Wake Forest, NC. FDA records list 3 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Signifier Medical Technologies Limited between 2021 and 2024. The busiest year on record is 2021, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240328 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | QNO | Substantially Equivalent | |
| K223446 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | QNO | Substantially Equivalent | |
| DEN200018 | eXciteOSA with remote and eXciteOSA without remote | QNO | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3018192374 | 3018192374 | SIGNIFIER MEDICAL TECHNOLOGIES LIMITED | Pall Mall, 1 Pollen Sq, 59 King Street, Manchester M2 4PD GB | 2026 | |
| 3017737771 | 3017737771 | SIGNIFIER MEDICAL TECHNOLOGIES LLC | 907 Gateway Commons Cir Ste 188, Wake Forest, NC 27587 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain