| Z-0475-2024 | Class II | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 | October 31, 2023 |
| Z-0476-2024 | Class II | STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 | October 31, 2023 |
| Z-0479-2024 | Class II | PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 | October 31, 2023 |
| Z-0478-2024 | Class II | PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 | October 31, 2023 |
| Z-0477-2024 | Class II | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102 | October 31, 2023 |
| Z-0480-2024 | Class II | 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN | October 31, 2023 |
| Z-0482-2024 | Class II | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205 | October 31, 2023 |
| Z-0481-2024 | Class II | PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP | October 31, 2023 |
| Z-0483-2024 | Class II | PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU | October 31, 2023 |
| Z-1993-2023 | Class II | HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Exp | May 16, 2023 |
| Z-0743-2023 | Class II | HeartWare Model 1101 | November 29, 2022 |
| Z-0748-2023 | Class II | HeartWare HVAD Pump Kit, REF 1104JP | November 29, 2022 |
| Z-0745-2023 | Class II | HeartWare HVAD Pump Kit, REF 1103 | November 29, 2022 |
| Z-0746-2023 | Class II | HeartWare HVAD Pump Kit, REF 1104 | November 29, 2022 |
| Z-0749-2023 | Class II | HeartWare HVAD Pump Kit, REF 1205 | November 29, 2022 |
| Z-0750-2023 | Class II | HeartWare HVAD Pump Kit, REF MCS1705PU | November 29, 2022 |
| Z-0747-2023 | Class II | HeartWare HVAD Pump Kit, REF 1104CA-CLIN | November 29, 2022 |
| Z-0742-2023 | Class II | HeartWare Model 1100 | November 29, 2022 |
| Z-0744-2023 | Class II | HeartWare Model 1102 | November 29, 2022 |
| Z-1512-2022 | Class I | HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE | June 28, 2022 |