| Z-1205-2025 | Class I | VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for us | January 5, 2025 |
| Z-1290-2024 | Class II | CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guidin | February 16, 2024 |
| Z-1319-2023 | Class II | Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 279 | February 21, 2023 |
| Z-1320-2023 | Class II | Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 27 | February 21, 2023 |
| Z-1677-2022 | Class II | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovasc | June 29, 2022 |
| Z-1287-2021 | Class II | Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx On | February 26, 2021 |
| Z-1286-2021 | Class II | Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Onl | February 26, 2021 |
| Z-1285-2021 | Class II | Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Onl | February 26, 2021 |
| Z-2372-2020 | Class II | PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usa | April 22, 2020 |
| Z-2371-2020 | Class II | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: | April 22, 2020 |
| Z-2878-2018 | Class I | WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523 | May 7, 2018 |
| Z-0058-2018 | Class II | THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S | September 6, 2017 |
| Z-0057-2018 | Class II | THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S) | September 6, 2017 |
| Z-0054-2018 | Class II | THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S | September 6, 2017 |
| Z-0056-2018 | Class II | THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S) | September 6, 2017 |
| Z-0055-2018 | Class II | THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S | September 6, 2017 |
| Z-0210-2018 | Class II | SMARTABLATE RF System Generator | June 14, 2017 |
| Z-0211-2018 | Class II | PENTARAY NAV High-Density Mapping Catheter. | May 17, 2017 |
| Z-0212-2018 | Class II | PENTARAY NAV High-Density Mapping Catheter. | May 17, 2017 |
| Z-2776-2016 | Class II | CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versio | August 15, 2016 |