| Z-2172-2026 | Class II | Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO | March 27, 2026 |
| Z-2080-2025 | Class I | Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number | May 14, 2025 |
| Z-2082-2025 | Class I | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A So | May 14, 2025 |
| Z-2083-2025 | Class I | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS S | May 14, 2025 |
| Z-2084-2025 | Class I | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A So | May 14, 2025 |
| Z-2085-2025 | Class I | Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS So | May 14, 2025 |
| Z-2081-2025 | Class I | Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number | May 14, 2025 |
| Z-0413-2024 | Class II | TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc | October 4, 2023 |
| Z-0410-2024 | Class II | Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravas | October 4, 2023 |
| Z-0409-2024 | Class II | Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. | October 4, 2023 |
| Z-0414-2024 | Class II | TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 | October 4, 2023 |
| Z-0411-2024 | Class II | FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intra | October 4, 2023 |
| Z-0412-2024 | Class II | FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intra | October 4, 2023 |
| Z-0238-2024 | Class II | Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 | September 7, 2023 |
| Z-2479-2023 | Class II | PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS | July 27, 2023 |
| Z-1379-2023 | Class II | Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exte | February 14, 2023 |
| Z-1380-2023 | Class II | Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Ext | February 14, 2023 |
| Z-0147-2023 | Class II | Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP | October 6, 2022 |
| Z-0146-2023 | Class II | Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 12080 | October 6, 2022 |
| Z-0835-2022 | Class II | FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10 | March 1, 2022 |