| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | Class II | Cardiovascular | 4 | 2025-12-12 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-12-12 | K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) | DTZ | Class II | Cardiovascular |
| 2025-11-24 | K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | DTZ | Class II | Cardiovascular |
| 2021-12-10 | K202510 | AMG PMP Infant | DTZ | Class II | Cardiovascular |
| 2021-04-01 | K202206 | AMG PMP Pediatric | DTZ | Class II | Cardiovascular |