Winter, FL, US · 3 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Class II | Anesthesiology | 2 | 2022-03-25 |
| CAW | — | — | — | 1 | 2020-07-24 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-02-04 | Class II | Ongoing | Z-1815-2026 | React Health PHOENIX 5L Oxygen Concentrator | — | Devices which did not meet internal quality specifications were inadvertently distributed. |
| 2024-11-27 | Class II | Ongoing | Z-0828-2025 | Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Numb… | — | The devices were inadvertently shipped after their expiration date. |