| Z-2412-2026 | Class II | Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # | May 18, 2026 |
| Z-2411-2026 | Class II | Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost El | May 18, 2026 |
| Z-2259-2026 | Class II | Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), A | April 30, 2026 |
| Z-2258-2026 | Class II | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M | April 30, 2026 |
| Z-2225-2026 | Class II | Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below pro | April 28, 2026 |
| Z-2229-2026 | Class II | Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-N | April 28, 2026 |
| Z-2227-2026 | Class II | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (7220 | April 28, 2026 |
| Z-2228-2026 | Class II | Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10 | April 28, 2026 |
| Z-2170-2026 | Class II | Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M | March 31, 2026 |
| 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-1667-2026 | Class II | ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; | March 3, 2026 |
| Z-1669-2026 | Class II | Allura Xper FD20/20; System Code: 722038; | March 3, 2026 |
| Z-1662-2026 | Class II | ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; | 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-1659-2026 | Class II | Allura Xper FD10C; System Code: 722001; | March 3, 2026 |
| Z-1666-2026 | Class II | ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; | March 3, 2026 |
| Z-1664-2026 | Class II | ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; | March 3, 2026 |
| Z-1676-2026 | Class II | Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; | March 3, 2026 |
| Z-1668-2026 | Class II | Allura Xper FD20/10; System Code: 722029; | March 3, 2026 |