| Z-2018-2025 | Class II | CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI O | May 28, 2025 |
| Z-1492-2025 | Class II | Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754 | March 3, 2025 |
| Z-1401-2024 | Class II | Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16 | February 20, 2024 |
| Z-1346-2023 | Class II | CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE | March 1, 2023 |
| Z-1345-2023 | Class II | CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 | March 1, 2023 |
| Z-1347-2023 | Class II | CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC | March 1, 2023 |
| Z-2350-2021 | Class II | Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188 | June 8, 2021 |
| Z-1790-2021 | Class II | The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for | April 16, 2021 |
| Z-1789-2021 | Class II | The Terumo HX2 Temperature Management System provides temperature control of two independent water c | April 16, 2021 |
| Z-1791-2021 | Class II | The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used | April 16, 2021 |
| Z-1367-2021 | Class II | Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft | March 2, 2021 |
| Z-0565-2021 | Class II | (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advan | November 11, 2020 |
| Z-2959-2020 | Class II | Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usa | August 25, 2020 |
| Z-2960-2020 | Class II | Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Pro | August 25, 2020 |
| Z-2961-2020 | Class II | Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usa | August 25, 2020 |
| Z-1109-2020 | Class II | Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is in | January 10, 2020 |
| Z-1111-2020 | Class II | Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indi | January 10, 2020 |
| Z-1108-2020 | Class II | Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is in | January 10, 2020 |
| Z-1110-2020 | Class II | Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use f | January 10, 2020 |
| Z-2104-2019 | Class II | Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion in | June 14, 2019 |