Company ยท FR
Voluntis Sa.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2025. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 30, 2025 | K250022 | HeroTracker Sense Voluntis, FR | CAF |
| Dec 12, 2023 | K232451 | Insulia Bolus Companion Voluntis Sa., FR | NDC |
| Jun 4, 2021 | K202596 | Insulia Diabetes Management Companion Voluntis Sa., FR | NDC |
| Nov 7, 2017 | K172177 | Insulia Diabetes Management Companion Voluntis Sa., FR | NDC |
| Jun 19, 2017 | K170669 | Insulia Diabetes Management Companion Voluntis Sa., FR | NDC |
| Nov 9, 2016 | K161433 | Insulia Diabetes Management Companion Voluntis Sa., FR | NDC |