North Andover, MA, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FPA | — | — | — | 1 | 2021-11-10 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-04-22 | Class II | Terminated | Z-1381-2022 | Ivenix Infusion System (IIS) | — | Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm. |