| Z-2518-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog | May 13, 2026 |
| Z-2519-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US | May 13, 2026 |
| Z-2520-2026 | Class II | Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 | May 13, 2026 |
| Z-1099-2026 | Class II | CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 10 | October 10, 2025 |
| Z-0508-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 10 | October 9, 2025 |
| Z-0505-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog | October 9, 2025 |
| Z-0506-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 1065 | October 9, 2025 |
| Z-0507-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, H | October 9, 2025 |
| Z-2291-2025 | Class I | Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Versi | June 23, 2025 |
| Z-2290-2025 | Class I | Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 | June 23, 2025 |
| Z-1570-2025 | Class I | HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Re | March 13, 2025 |
| Z-2583-2024 | Class II | HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist Sys | June 25, 2024 |
| Z-1921-2024 | Class I | Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L128 | May 8, 2024 |
| Z-1692-2024 | Class I | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly | March 1, 2024 |
| Z-1693-2024 | Class I | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly | March 1, 2024 |
| Z-1300-2024 | Class I | HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend | February 19, 2024 |
| Z-1301-2024 | Class I | HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Re | February 19, 2024 |
| Z-0842-2024 | Class I | 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Renta | January 3, 2024 |
| Z-2658-2023 | Class II | Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring K | August 7, 2023 |
| Z-0308-2022 | Class II | Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU) | October 22, 2021 |