| Z-2413-2026 | Class II | Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water V | May 12, 2026 |
| Z-2048-2026 | Class II | LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, | March 30, 2026 |
| Z-2049-2026 | Class II | LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe) | March 30, 2026 |
| Z-1771-2026 | Class I | Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model | March 19, 2026 |
| Z-1770-2026 | Class I | Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization | March 19, 2026 |
| Z-1551-2026 | Class II | EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UP | February 10, 2026 |
| Z-1163-2026 | Class I | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): | December 19, 2025 |
| Z-1159-2026 | Class I | AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M005536 | December 19, 2025 |
| Z-1162-2026 | Class I | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M0 | December 19, 2025 |
| Z-1161-2026 | Class I | HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00 | December 19, 2025 |
| Z-1158-2026 | Class I | AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M0055 | December 19, 2025 |
| Z-1160-2026 | Class I | AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M005536 | December 19, 2025 |
| Z-1042-2026 | Class II | Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, | December 3, 2025 |
| Z-0139-2026 | Class II | TENACIO Pump without InhibiZone; UPN: 72404420; | September 11, 2025 |
| Z-0141-2026 | Class II | LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18 | September 11, 2025 |
| Z-0142-2026 | Class II | CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 | September 11, 2025 |
| Z-0138-2026 | Class II | TENACIO Pump with InhibiZone; UPN: 72404429; | September 11, 2025 |
| Z-0143-2026 | Class II | CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 7240446 | September 11, 2025 |
| Z-0140-2026 | Class II | CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21C | September 11, 2025 |
| Z-0144-2026 | Class II | LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 7240445 | September 11, 2025 |