| Z-3081-2026 | Class II | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model | August 6, 2026 |
| Z-3082-2026 | Class II | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model | August 6, 2026 |
| Z-3083-2026 | Class II | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model | August 6, 2026 |
| Z-3188-2026 | Class II | Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adapt | July 22, 2026 |
| Z-2961-2026 | Class II | OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device. | July 14, 2026 |
| Z-2962-2026 | Class II | Suture Cinch Long 1pk. Endoscopic tissue approximation device. | July 14, 2026 |
| Z-2977-2026 | Class I | Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutan | July 9, 2026 |
| Z-2978-2026 | Class I | Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Per | July 9, 2026 |
| Z-2840-2026 | Class II | Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 2 | June 30, 2026 |
| Z-2725-2026 | Class II | Rapid Refill Continuous Injection System, UPN M00566001 | June 30, 2026 |
| Z-2838-2026 | Class II | Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial | June 30, 2026 |
| Z-2839-2026 | Class II | Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw | June 30, 2026 |
| Z-2771-2026 | Class II | Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological | June 19, 2026 |
| Z-2754-2026 | Class II | FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the cham | June 11, 2026 |
| Z-2751-2026 | Class II | FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation C | June 11, 2026 |
| Z-2752-2026 | Class II | FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter | June 11, 2026 |
| Z-2750-2026 | Class II | FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Car | June 11, 2026 |
| Z-2753-2026 | Class II | FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Car | June 11, 2026 |
| Z-2755-2026 | Class II | FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers | June 11, 2026 |
| Z-2757-2026 | Class II | FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the cham | June 11, 2026 |