| D-0581-2026 | Class III | Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL | May 14, 2026 |
| Z-2223-2026 | Class I | LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. | May 6, 2026 |
| Z-2224-2026 | Class I | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | May 6, 2026 |
| D-0425-2026 | Class II | 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius | March 11, 2026 |
| D-0428-2026 | Class II | 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex | March 11, 2026 |
| D-0431-2026 | Class II | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freefle | March 11, 2026 |
| D-0432-2026 | Class II | 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex | March 11, 2026 |
| D-0433-2026 | Class II | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freef | March 11, 2026 |
| D-0437-2026 | Class II | 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Freseni | March 11, 2026 |
| D-0435-2026 | Class II | 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius | March 11, 2026 |
| D-0434-2026 | Class II | 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freef | March 11, 2026 |
| D-0430-2026 | Class II | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freefle | March 11, 2026 |
| D-0429-2026 | Class II | 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Frankl | March 11, 2026 |
| D-0424-2026 | Class II | 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL fre | March 11, 2026 |
| D-0436-2026 | Class II | 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius | March 11, 2026 |
| D-0426-2026 | Class II | 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freef | March 11, 2026 |
| D-0427-2026 | Class II | 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex | March 11, 2026 |
| Z-2274-2026 | Class II | The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004. | February 4, 2026 |
| 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 |