| Z-1125-2026 | Class II | Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261 | December 4, 2025 |
| Z-1128-2026 | Class II | Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B | December 4, 2025 |
| Z-1129-2026 | Class II | Allwell Angioplasty Pack REF: IS-30-B1/B | December 4, 2025 |
| Z-1123-2026 | Class II | Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130 | December 4, 2025 |
| Z-1124-2026 | Class II | Allwell Inflation Device, for angiographic use REF: IS-30-A | December 4, 2025 |
| Z-1126-2026 | Class II | Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05 | December 4, 2025 |
| Z-1127-2026 | Class II | Merit Medical , Custom Manifold Kit REF: K09-13203A | December 4, 2025 |
| Z-0533-2026 | Class II | PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-0 | August 4, 2025 |
| Z-2553-2025 | Class II | 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 0088445 | July 25, 2025 |
| Z-2294-2025 | Class II | Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029 | June 5, 2025 |
| Z-2295-2025 | Class II | Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, | June 5, 2025 |
| Z-2296-2025 | Class II | Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05 | June 5, 2025 |
| Z-2293-2025 | Class II | High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C | June 5, 2025 |
| Z-1641-2025 | Class II | Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery | March 14, 2025 |
| Z-1640-2025 | Class II | Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly | March 14, 2025 |
| Z-1434-2025 | Class II | Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D | January 27, 2025 |
| Z-0062-2025 | Class II | Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Infl | August 30, 2024 |
| Z-0057-2025 | Class II | Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Ballo | August 30, 2024 |
| Z-0061-2025 | Class II | Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion To | August 30, 2024 |
| Z-0060-2025 | Class II | Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device R | August 30, 2024 |