| Z-1805-2026 | Class II | Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Intervent | March 19, 2026 |
| Z-1692-2026 | Class II | Vue Motion V12. Product Number: 1017979. | March 5, 2026 |
| Z-1666-2026 | Class II | ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; | March 3, 2026 |
| Z-1672-2026 | Class II | Allura Xper FD20/15 OR Table; System Code: 722059; | March 3, 2026 |
| Z-1678-2026 | Class II | Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); | March 3, 2026 |
| Z-1664-2026 | Class II | ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; | March 3, 2026 |
| Z-1668-2026 | Class II | Allura Xper FD20/10; System Code: 722029; | March 3, 2026 |
| Z-1660-2026 | Class II | ALLURA Xper FD10F; System Code: 722002; | March 3, 2026 |
| Z-1673-2026 | Class II | Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; | March 3, 2026 |
| Z-1676-2026 | Class II | Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; | March 3, 2026 |
| Z-1679-2026 | Class II | Azurion 5 M12; System Code: (1)722227, (2)722231; | March 3, 2026 |
| Z-1670-2026 | Class II | Allura Xper FD20/20 OR Table; System Code: 722039; | March 3, 2026 |
| Z-1661-2026 | Class II | ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; | March 3, 2026 |
| Z-1675-2026 | Class II | Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; | March 3, 2026 |
| Z-1680-2026 | Class II | Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); | March 3, 2026 |
| Z-1674-2026 | Class II | Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); | March 3, 2026 |
| Z-1663-2026 | Class II | ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; | March 3, 2026 |
| Z-1662-2026 | Class II | ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; | March 3, 2026 |
| Z-1667-2026 | Class II | ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; | March 3, 2026 |
| Z-1677-2026 | Class II | Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; | March 3, 2026 |