| Z-1098-2026 | Class II | Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9 | December 4, 2025 |
| Z-0726-2026 | Class II | Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrilla | October 29, 2025 |
| Z-2169-2025 | Class II | Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software compone | June 18, 2025 |
| Z-2168-2025 | Class II | Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software compo | June 18, 2025 |
| Z-2128-2025 | Class II | Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with t | June 17, 2025 |
| Z-2127-2025 | Class II | Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the foll | June 17, 2025 |
| Z-1924-2025 | Class II | Azure S DR MRI SureScan, Product number W3DR01 | April 29, 2025 |
| Z-3152-2024 | Class II | 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2 | July 11, 2024 |
| Z-2211-2024 | Class II | CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2206-2024 | Class II | COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2202-2024 | Class II | MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2190-2024 | Class II | COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2197-2024 | Class II | EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2204-2024 | Class II | MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2191-2024 | Class II | COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2194-2024 | Class II | COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2210-2024 | Class II | COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2201-2024 | Class II | MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2205-2024 | Class II | MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator | April 16, 2024 |
| Z-2209-2024 | Class II | Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator | April 16, 2024 |