Tissium SA
Medical device manufacturer.
1510(k) clearances
0PMA approvals
8recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251957 | Coaptium Connect with Tissium LightSFD · Special | 09/08/2025SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2908-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | 06/15/2026Open, Classified |
| Z-2907-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | 06/15/2026Open, Classified |
| Z-2906-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | 06/15/2026Open, Classified |
| Z-2905-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | 06/15/2026Open, Classified |
| Z-2904-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | 06/15/2026Open, Classified |
| Z-2903-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | 06/15/2026Open, Classified |
| Z-2902-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | 06/15/2026Open, Classified |
| Z-2901-2026 Class II | Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | 06/15/2026Open, Classified |