| 128286 | 1081502026 | P250022 | Volt PFA System | QZI | 2025-12-19 |
| 128286 | 1847145763 | P220013 | TactiFlex Ablation Catheter, Sensor Enabled, TactiSys Quartz Equipment, TactiSys Quartz, TactiFlex Radiofrequency C | OAE | 2023-05-18 |
| 128286 | 1364977690 | P130026 | TACTICATH QUARTZ SET | OAE | 2014-10-24 |
| 128286 | 1906099585 | P110016 | THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR | OAD | 2012-01-25 |
| 128286 | 1519050996 | K961924 | IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | DRF | 1997-04-11 |
| 128286 | 2071295025 | K894500 | DAIG ELECTROPHYSIOLOGY CATHETER | DRF | 1989-09-18 |
| 128286 | 1292433415 | K252013 | EnSite X EP System | DQK | 2025-09-25 |
| 128286 | 2022175301 | K251234 | EnSite X EP System | DQK | 2025-07-30 |
| 128286 | 1826487014 | K251231 | ViewFlex X ICE Catheter, Sensor Enabled | OBJ | 2025-05-20 |
| 128286 | 1219462594 | K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach | OBJ | 2025-05-23 |
| 128286 | 1701008709 | K243493 | Agilis NxT Steerable Introducer Dual-Reach | DYB | 2024-12-13 |
| 128286 | 1921629173 | K242016 | EnSite X EP System | DQK | 2024-08-09 |
| 128286 | 2056527922 | K241372 | Advisor HD Grid X Mapping Catheter, Sensor Enabled | MTD | 2024-07-09 |
| 128286 | 1644202159 | K241370 | Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) | DYB | 2024-06-13 |
| 128286 | 1897877020 | K231415 | EnSite X EP System | DQK | 2023-08-10 |
| 128286 | 1812947597 | K223094 | EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software License | DQK | 2022-12-27 |
| 128286 | 1296019727 | K223077 | ViewFlex Xtra ICE Catheter | OBJ | 2022-12-07 |
| 128286 | 1363009581 | K221213 | EnSite X EP System | DQK | 2022-08-18 |
| 128286 | 1469381285 | K213364 | EnSite X EP System | DQK | 2021-11-11 |
| 128286 | 1055503877 | K212061 | EnSite X EP System | DQK | 2021-10-22 |
| 128286 | 1108038189 | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled | DQK | 2020-11-25 |
| 128286 | 2059853676 | K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | DQK | 2020-06-26 |
| 128286 | 1071867675 | K201148 | EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License | DQK | 2020-06-26 |
| 128286 | 1471627600 | K192037 | Advisor VL Circular Mapping Catheter, Sensor Enabled | DRF | 2019-09-17 |
| 128286 | 1117700999 | K180558 | PressureWire X | DXO | 2018-03-28 |
| 128286 | 1494029169 | K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | MTD | 2018-04-23 |
| 128286 | 1457936784 | K161171 | PressureWire X Guidewire | DXO | 2016-08-15 |
| 128286 | 1934457447 | K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D | DRF | 2016-12-13 |
| 128286 | 1298388272 | K160210 | EnSite Precision Cardiac Mapping System v2.0 | DQK | 2016-12-13 |
| 128286 | 1604801522 | K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter | DRF | 2015-07-15 |
| 128286 | 1205996543 | K141769 | OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER | DQO | 2014-08-18 |
| 128286 | 1977710451 | K140466 | PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 | DXO | 2014-11-13 |
| 128286 | 1351487501 | K133853 | VIEWFLEX XTRA ICE CATHETER | OBJ | 2014-05-19 |
| 128286 | 1528403137 | K133587 | PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 | DRG | 2013-12-20 |
| 128286 | 1078152797 | K131452 | PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 | DXO | 2013-09-05 |
| 128286 | 1390168692 | K122587 | BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 | DRC | 2013-02-07 |
| 128286 | 1340397576 | K113584 | PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER | DXO | 2012-03-02 |
| 128286 | 1019140892 | K110450 | AGILIS NXT STEERABLE INTRODUCER | DYB | 2011-05-10 |
| 128286 | 1577573083 | K083083 | AGILIS NXT STEERABLE INTRODUCER | DYB | 2008-11-06 |
| 128286 | 1280029022 | K081803 | ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM | DRF | 2009-05-13 |
| 128286 | 1267143455 | K081645 | AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 | DYB | 2008-12-09 |
| 128286 | 1442015302 | K061363 | AGILIS NXT STEERABLE INTRODUCER | DYB | 2006-07-12 |
| 128286 | 1279944920 | K002976 | RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX | DRF | 2000-12-22 |
| 128286 | 1422342240 | | | | |