| Z-0110-2026 | Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac | September 10, 2025 |
| Z-0112-2026 | Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac | September 10, 2025 |
| Z-0113-2026 | Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac cat | September 10, 2025 |
| Z-0109-2026 | Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac cat | September 10, 2025 |
| Z-0111-2026 | Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac | September 10, 2025 |
| Z-1644-2025 | Class II | Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 | March 17, 2025 |
| Z-1643-2025 | Class II | Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080 | March 17, 2025 |
| Z-1479-2024 | Class II | ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 | March 4, 2024 |
| Z-1480-2024 | Class II | Alinity i Anti-HCV Reagent Kit, List Number 08P0521 | March 4, 2024 |
| Z-0209-2024 | Class II | Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator | September 28, 2023 |
| Z-2110-2023 | Class I | Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (car | June 12, 2023 |
| Z-1344-2022 | Class II | Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For m | June 9, 2022 |
| Z-1213-2022 | Class II | FIRMap" Catheter, 60mm Basket | April 28, 2022 |
| Z-0956-2022 | Class II | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF | March 24, 2022 |
| Z-0957-2022 | Class II | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, | March 24, 2022 |
| Z-0420-2022 | Class II | Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM | November 16, 2021 |
| Z-0895-2022 | Class II | Amplatzer Steerable Delivery Sheath | November 9, 2021 |
| Z-2541-2020 | Class II | TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) a | May 22, 2020 |
| Z-1700-2020 | Class II | Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System | February 28, 2020 |
| Z-1220-2019 | Class II | St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The | November 19, 2018 |