| Z-1068-2024 | Class II | Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, an | December 19, 2023 |
| Z-1409-2021 | Class III | Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Viny | January 28, 2021 |
| Z-0318-2021 | Class II | 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only | June 24, 2019 |
| Z-0183-2019 | Class II | ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinfor | August 21, 2018 |
| Z-0182-2019 | Class II | Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced D | August 21, 2018 |
| Z-0179-2019 | Class II | Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula | August 21, 2018 |
| Z-0181-2019 | Class II | Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced | August 21, 2018 |
| Z-0102-2019 | Class II | Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula | August 21, 2018 |
| Z-0180-2019 | Class II | Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced D | August 21, 2018 |
| Z-0184-2019 | Class II | Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced | August 21, 2018 |
| Z-0021-2018 | Class I | The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement | August 2, 2017 |
| Z-1227-2019 | Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F | January 17, 2017 |
| Z-1228-2019 | Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F | January 17, 2017 |
| Z-1232-2019 | Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F | January 17, 2017 |
| Z-1230-2019 | Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F | January 17, 2017 |
| Z-1231-2019 | Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F | January 17, 2017 |
| Z-1229-2019 | Class I | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F | January 17, 2017 |
| Z-0269-2019 | Class I | REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Pr | March 30, 2015 |
| Z-1456-2015 | Class I | OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufacture | March 30, 2015 |