| Z-0459-2026 | Class II | Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 | October 6, 2025 |
| Z-0458-2026 | Class II | Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 | October 6, 2025 |
| Z-1557-2025 | Class II | Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF | February 15, 2025 |
| Z-0753-2025 | Class II | The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, ded | November 21, 2024 |
| Z-0493-2025 | Class II | Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile | October 17, 2024 |
| Z-0494-2025 | Class II | Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile | October 17, 2024 |
| Z-0492-2025 | Class II | Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile | October 17, 2024 |
| Z-0495-2025 | Class II | Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile | October 17, 2024 |
| Z-0491-2025 | Class II | Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile | October 17, 2024 |
| Z-0552-2025 | Class III | Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the Merlin | October 1, 2024 |
| Z-0551-2025 | Class III | Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer sto | October 1, 2024 |
| Z-2432-2024 | Class II | Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only | May 22, 2024 |
| Z-2431-2024 | Class II | Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only | May 22, 2024 |
| Z-2430-2024 | Class II | Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only | May 22, 2024 |
| Z-2429-2024 | Class II | Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only | May 22, 2024 |
| Z-2367-2024 | Class II | Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only | May 16, 2024 |
| Z-2364-2024 | Class II | Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only | May 16, 2024 |
| Z-2359-2024 | Class II | Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only | May 16, 2024 |
| Z-2358-2024 | Class II | Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only | May 16, 2024 |
| Z-2362-2024 | Class II | Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only | May 16, 2024 |