Cincinnati, OH, US · 2 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| BTR | — | — | — | 2 | 2021-10-21 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-05-16 | Class II | Ongoing | Z-2148-2023 | Aeris Balloon Dilation Catheter | — | Devices were mislabeled. |