Cincinnati, OH, US · 3 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | Class II | Anesthesiology | 3 | 2026-09-03 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-05-16 | Class II | Ongoing | Z-2148-2023 | Aeris Balloon Dilation Catheter | — | Devices were mislabeled. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-03 | K251794 | Tenax® Laser Resistant Endotracheal Tube | BTR | Class II | Anesthesiology |
| 2021-10-21 | K213028 | Tenax Laser Resistant Endotracheal Tube | BTR | Class II | Anesthesiology |
| 2020-11-25 | K200761 | Tenax Laser Resistant Endotracheal Tube | BTR | Class II | Anesthesiology |