| Harmony™ | 00763000585242 | Medtronic, Inc. | Class III | |
| Harmony™ | 00763000585259 | Medtronic, Inc. | Class III | |
| PULSTA™ Transcatheter Pulmonary Valve System | 08809643759632 | Taewoong Medical Co., Ltd. | Class III | |
| PULSTA™ Transcatheter Pulmonary Valve System | 08809643759649 | Taewoong Medical Co., Ltd. | Class III | |
| PULSTA™ Transcatheter Pulmonary Valve System | 08809643759656 | Taewoong Medical Co., Ltd. | Class III | |
| PULSTA™ Transcatheter Pulmonary Valve System | 08809643759687 | Taewoong Medical Co., Ltd. | Class III | |
| PULSTA™ Transcatheter Pulmonary Valve System | 08809643759694 | Taewoong Medical Co., Ltd. | Class III | |
| PULSTA™ Transcatheter Pulmonary Valve System | 08809643759700 | Taewoong Medical Co., Ltd. | Class III | |
| PULSTA™ Transcatheter Pulmonary Valve System | 08809643759854 | Taewoong Medical Co., Ltd. | Class III | |
| PULSTA™ Transcatheter Pulmonary Valve System | 08809643759861 | Taewoong Medical Co., Ltd. | Class III | |
| PULSTA™ Transcatheter Pulmonary Valve System | 08809643759885 | Taewoong Medical Co., Ltd. | Class III | |
| PULSTA™ Transcatheter Pulmonary Valve System | 08809643759892 | Taewoong Medical Co., Ltd. | Class III | |
| PULSTA™ Transcatheter Pulmonary Valve System | 08809643759908 | Taewoong Medical Co., Ltd. | Class III | |
| VenusP-Valve System | 06970872490190 | Venus Medtech (Hangzhou) Inc. MF | Class III | |
| VenusP-Valve System | 06970872490206 | Venus Medtech (Hangzhou) Inc. MF | Class III | |
| VenusP-Valve System | 06970872490268 | Venus Medtech (Hangzhou) Inc. MF | Class III | |
| VenusP-Valve System | 06970872490275 | Venus Medtech (Hangzhou) Inc. MF | Class III | |
| VenusP-Valve System | 06970872490282 | Venus Medtech (Hangzhou) Inc. MF | Class III | |
| VenusP-Valve System | 06970872490299 | Venus Medtech (Hangzhou) Inc. MF | Class III | |
| VenusP-Valve System | 06970872490305 | Venus Medtech (Hangzhou) Inc. MF | Class III | |
| VenusP-Valve System | 06970872490312 | Venus Medtech (Hangzhou) Inc. MF | Class III | |
| VenusP-Valve System | 06970872490329 | Venus Medtech (Hangzhou) Inc. MF | Class III | |
| VenusP-Valve System | 06970872490336 | Venus Medtech (Hangzhou) Inc. MF | Class III | |