Company ยท US
Soterix Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2026. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 20, 2026 | K251653 | SPRY TMS Therapy System (0550) Soterix Medical, Inc. | OBP |
| Jun 3, 2024 | K233751 | Milieve (YPS-301BD) Soterix Medical, Inc. | PCC |
| Mar 25, 2024 | K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) Soterix Medical, Inc. | GWF |
| Aug 13, 2021 | K192823 | MEGA-TMS Soterix Medical, Inc. | GWF |
| Apr 6, 2020 | K191422 | Neural Navigator Soterix Medical, Inc. | HAW |
| May 1, 2017 | K170291 | IontoDC Soterix Medical, Inc. | EGJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||