| Z-1310-2022 | Class II | TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 | April 26, 2022 |
| Z-1298-2022 | Class II | Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TE | April 19, 2022 |
| Z-1617-2020 | Class II | TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4 | February 19, 2020 |
| Z-0896-2020 | Class II | CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory com | October 21, 2019 |
| Z-0895-2020 | Class II | CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory com | October 21, 2019 |
| Z-0892-2020 | Class II | CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related accessory compon | October 21, 2019 |
| Z-0894-2020 | Class II | CS Elite Fastpack, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory com | October 21, 2019 |
| Z-0897-2020 | Class II | JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory components are intended | October 21, 2019 |
| Z-0891-2020 | Class II | Cell Saver¿5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related accessory comp | October 21, 2019 |
| Z-0887-2020 | Class II | High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory co | October 21, 2019 |
| Z-0899-2020 | Class II | JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are intended to be | October 21, 2019 |
| Z-0906-2020 | Class II | Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be | October 21, 2019 |
| Z-0901-2020 | Class II | Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory components are inte | October 21, 2019 |
| Z-0885-2020 | Class II | CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory com | October 21, 2019 |
| Z-0888-2020 | Class II | CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory com | October 21, 2019 |
| Z-0893-2020 | Class II | CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related accessory compon | October 21, 2019 |
| Z-0889-2020 | Class II | CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory compo | October 21, 2019 |
| Z-0905-2020 | Class II | Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are intended to be | October 21, 2019 |
| Z-0898-2020 | Class II | JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended | October 21, 2019 |
| Z-0904-2020 | Class II | JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are intended fo | October 21, 2019 |