| Z-1551-2026 | Class II | EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UP | February 10, 2026 |
| Z-1160-2026 | Class I | AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M005536 | 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-1161-2026 | Class I | HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00 | December 19, 2025 |
| 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-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-0138-2026 | Class II | TENACIO Pump with InhibiZone; UPN: 72404429; | 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 |
| Z-0140-2026 | Class II | CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21C | 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-0139-2026 | Class II | TENACIO Pump without InhibiZone; UPN: 72404420; | 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-0143-2026 | Class II | CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 7240446 | September 11, 2025 |
| Z-2618-2025 | Class II | Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 | August 28, 2025 |
| Z-0103-2026 | Class I | Model Number U225 VISIONIST CRT-P EL | August 20, 2025 |
| Z-0086-2026 | Class I | PROPONENT DR SL (Model L201) | August 20, 2025 |
| Z-0095-2026 | Class I | Model Number L111, ESSENTIO DR SL MRI Pacemaker | August 20, 2025 |
| Z-0104-2026 | Class I | Model Number U226, VISIONIST CRT-P EL | August 20, 2025 |