| Z-1048-2026 | Class II | Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005. | November 21, 2025 |
| Z-0885-2026 | Class I | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration o | November 14, 2025 |
| D-0182-2026 | Class I | Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, L | November 6, 2025 |
| Z-0848-2026 | Class II | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. | November 3, 2025 |
| Z-0586-2026 | Class I | IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, D | November 3, 2025 |
| Z-0378-2026 | Class II | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. | September 3, 2025 |
| Z-2233-2025 | Class II | LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product | June 24, 2025 |
| Z-2235-2025 | Class II | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Pro | June 24, 2025 |
| Z-2234-2025 | Class II | LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25. | June 24, 2025 |
| Z-2232-2025 | Class II | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product | June 24, 2025 |
| Z-1869-2025 | Class I | IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh | May 12, 2025 |
| Z-1019-2025 | Class I | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in ou | January 10, 2025 |
| Z-0763-2025 | Class I | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | December 6, 2024 |
| Z-3153-2024 | Class I | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion | August 30, 2024 |
| Z-2721-2024 | Class I | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product | August 1, 2024 |
| Z-1484-2024 | Class I | LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. | March 7, 2024 |
| Z-0549-2024 | Class I | Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 | November 29, 2023 |
| Z-1283-2024 | Class II | LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 | May 10, 2023 |
| Z-1313-2023 | Class I | Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 | March 10, 2023 |
| D-0129-2023 | Class II | Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bita | November 22, 2022 |