| AcQMap High Resolution Imaging and Mapping System (K212345) | Acutus Medical, Inc. | 2021-08-27 |
| iMap 3D Mapping & Navigation System (iMap System) (K201094) | Cardionxt, Inc. | 2021-08-16 |
| AcQMap High Resolution Imaging and Mapping System (K210680) | Acutus Medical, Inc. | 2021-08-05 |
| HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform (K211465) | Edwards Lfesciences | 2021-07-08 |
| iLab Polaris Multi-Modality Guidance System (K210889) | Boston Scientific Corporation | 2021-06-25 |
| HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index (K203687) | Edwards Lifesciences, LLC | 2021-05-28 |
| Zio ECG Utilization Software (ZEUS) System (K202527) | iRhythm Technologies, Inc. | 2021-05-21 |
| Spacelabs Lifescreen PRO Analyzer (K201921) | Spacelabs Healthcare, Ltd. | 2021-03-26 |
| WorkMate Claris System (K210392) | Abbott | 2021-03-11 |
| AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter (K201081) | Philips Medical System Nederland B.V. | 2020-12-17 |
| Graffiti (K202189) | Ge Medical Systems Information Technologies, Inc. | 2020-12-08 |
| AcQMap High Resolution Imaging and Mapping System (K201015) | Acutus Medical, Inc. | 2020-12-01 |
| 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 (K202066) | ABBOTT MEDICAL | 2020-11-25 |
| CARTO® 3 EP Navigation System with Signal Processing Unit (K200484) | Biosense Webster, Inc. | 2020-11-25 |
| Cordiana Dx16 (K201060) | Cordiana Medical Informatics AG | 2020-11-16 |
| CoroFlow Cardiovascular System (K201881) | Coroventis Research AB | 2020-11-13 |
| KardiaAI (K201985) | AliveCor, Inc. | 2020-11-12 |
| HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (K201446) | Edwards Lifesiences, LLC | 2020-10-01 |
| VX1 (K201298) | Volta Medical | 2020-09-16 |
| VIVO (K200313) | Catheter Precision, Inc. | 2020-09-14 |
| AVVIGO Guidance System (K201713) | Boston Scientific Corporation | 2020-07-23 |
| EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System (K201181) | ABBOTT MEDICAL | 2020-06-26 |
| EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License (K201148) | ABBOTT MEDICAL | 2020-06-26 |
| iLab Polaris Multi-Modality Guidance System (K201178) | Boston Scientific | 2020-05-29 |
| AcQMap High Resolution Imaging and Mapping System (K193013) | Acutus Medical, Inc. | 2020-02-11 |
| Rhythmia HDxTM Mapping System (K192438) | Boston Scientific Corporation | 2019-11-27 |
| AcQMap High Resolution Imaging and Mapping System (K191392) | Acutus Medical, Inc. | 2019-09-06 |
| HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module (K190205) | Edwards Lifesciences, LLC | 2019-08-29 |
| Zio XT ECG Monitoring System, Zio AT ECG Monitoring System (K190593) | iRhythm Technologies, Inc. | 2019-08-23 |
| CARTO 3 EP Navigation System, Version 7.1 and Accessories (K191660) | Biosense Webster, Inc. | 2019-07-20 |
| iLab Polaris Multi-Modality Guidance System (K191008) | Boston Scientific Corporation | 2019-07-02 |
| Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle (K190106) | Centerline Biomedical, Inc. | 2019-06-24 |
| VIVO (K183195) | Catheter Precision, Inc. | 2019-06-14 |
| Edwards Pressure Cable (K191089) | Edwards Lifesciences, LLC | 2019-06-13 |
| AcQMap High Resolution Imaging and Mapping System (K190131) | Acutus Medical, Inc. | 2019-04-02 |
| KardiaAI (K181823) | AliveCor, Inc. | 2019-03-11 |
| RhythmAnalytics (K182344) | Biofourmis Singapore Pte., Ltd. | 2019-03-07 |
| EP-TRACER System (K183266) | Schwarzer Cardiotek GmbH | 2019-03-01 |
| QUANTIEN Measurement System (K183099) | St. Jude Medical (Now Abbott Medical) | 2019-02-28 |
| AcQMap High Resolution Imaging and Mapping System (K181577) | Acutus Medical, Inc. | 2019-02-07 |
| EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (K183128) | Abbott | 2018-12-12 |
| AI-ECG Platform (K180432) | Shenzhen Carewell Electronics., Ltd. | 2018-11-19 |
| HemoSphere Advanced Monitor, HemoSphere Pressure Cable (K180881) | Edwards Lifesciences, LLC | 2018-11-16 |
| CardioInsight Cardiac Mapping System (K181918) | Medtronic, Inc. | 2018-11-08 |
| KODEX EPD System (K180940) | Philips Medical Systems Nederland B.V. | 2018-10-24 |
| EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (K182644) | Abbott | 2018-10-19 |
| Zio AT ECG Monitoring System, ZEUS System (K181502) | iRhythm Technologies, Inc. | 2018-08-29 |
| CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module (K173978) | Biosense Webster, Inc. | 2018-08-24 |
| Pure EP (K180805) | Biosig Technologies | 2018-08-08 |
| Epiphany Cardio Server Mobile (K181720) | Epiphany Healthcare, LLC | 2018-07-30 |
| RHYTHMIA HDx Mapping System (with software Version 2.0) (K173837) | Boston Scientific Corporation | 2018-07-25 |
| CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module (K173977) | Biosense Webster, Inc. | 2018-06-14 |
| CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT (K180238) | Biosense Webster, Inc. | 2018-06-01 |
| EnSite Velocity Cardiac Mapping System v5.2 (K172396) | St Jude Medical | 2018-04-23 |
| AcQMap High Resolution Imaging and Mapping System (K170948) | Acutus Medical, Inc. | 2017-10-16 |
| RhythmView Workstation (K171583) | Abbott Electrophysiology | 2017-09-01 |
| QUANTIEN Measurement System (K172182) | St. Jude Medical (Now Part of the Abbott Medical) | 2017-08-18 |
| CARTO 3 EP Navigation System, Version 6.0 and Accessories (K170600) | Biosense Webster, Inc. | 2017-07-25 |
| HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable (K163381) | Edwards Lifesciences, LLC | 2017-04-14 |
| CardioDay V2.5 (K162023) | Getemed Medizin- Und Informationstechnik AG | 2017-03-24 |
| RHYTHMIA HDx Mapping System (K162793) | Boston Scientific Corporation | 2017-03-10 |
| MediGuide Technology System (K162643) | St Jude Medical | 2016-12-13 |
| AutoMark Module (K160218) | St Jude Medical | 2016-12-13 |
| EnSite Precision Cardiac Mapping System v2.0 (K160210) | St Jude Medical | 2016-12-13 |
| CardioInsight Cardiac Mapping System (K162440) | Cardioinsight Technologies, Inc. | 2016-11-04 |
| Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 (K160187) | St Jude Medical | 2016-10-21 |
| EnSite Velocity Surface Electrode Kit (K160186) | St Jude Medical | 2016-10-07 |
| Sentry WEB SmartInterp (K153654) | Carefusion Germany 234 GmbH | 2016-09-16 |
| CardioConfirm (K161465) | Mortara Instrument, Inc. | 2016-09-03 |
| Rhythm View Workstation (non-streaming) (K161240) | Abbott Electrophysiology | 2016-08-10 |
| EP-TRACER System (K161245) | Cardio Tek, BV | 2016-08-05 |
| Merge Hemo (K152864) | Merge Healthcare Incorporated | 2016-04-07 |
| SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM (K152881) | Spacelabs Healthcare, Ltd. | 2016-04-01 |
| Navik 3D (K152160) | Apn Health, LLC | 2016-02-23 |
| Holter System (K151787) | Edan Instruments, Inc. | 2016-01-27 |
| MUSE Cardiology Information System (K152993) | Ge Medical Systems Information Technologies, Inc. | 2016-01-12 |
| WorkMate Claris System, WorkMate Claris System Display Plus (K151911) | St Jude Medical | 2015-10-22 |
| iLab Polaris Multi-Modality Guidance System (K151613) | Boston Scientific Corporation | 2015-10-06 |
| TM eCloud ECG Analysis System (K142349) | Telemed Solutions, Inc. | 2015-09-21 |
| Rhythm View Workstation (non-streaming, steaming option) (K151245) | Topera, Inc. | 2015-09-15 |
| ECVUE Mapping System (K150990) | Cardioinsight Technologies, Inc. | 2015-07-02 |
| Sensis (K150493) | Siemens Medi Cal Solutions, Inc. | 2015-06-30 |
| ADH 200 Analyzer Software (K143449) | Adams Meditech, LLC | 2015-06-26 |
| RhythmView Workstation (K142901) | Topera, Inc. | 2014-12-19 |
| ZEUS (ZIO ECG Utilization Service) System (K142681) | iRhythm Technologies, Inc. | 2014-11-21 |
| ECVUE MAPPING SYSTEM (K140497) | Cardioinsight Technologies, Inc. | 2014-11-19 |
| CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 (K133916) | Biosense Webster, Inc. | 2014-07-01 |
| ENSITE VELOCITY SYSTEM (K141050) | St Jude Medical | 2014-06-06 |
| V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM (K141185) | Boston Scientific Corp | 2014-06-06 |
| MCKESSON CARDIOLOGY ECG MOBILE (K133534) | Mckesson Israel , Ltd. | 2014-04-18 |
| EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM (K134044) | Cardio Tek, BV | 2014-03-31 |
| CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 (K132782) | Biosense Webster, Inc. | 2014-01-24 |
| RHYTHM VIEW WORKSTATION (K133305) | Topera, Inc. | 2013-12-16 |
| MARS HOLTER ANALYSIS WORKSTATION (K132437) | Ge Medical Systems Information Technologies, Inc. | 2013-12-04 |
| EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE (K132073) | St Jude Medical | 2013-09-09 |
| ENSITE VELOCITY SYSTEM (K130727) | St Jude Medical | 2013-08-29 |
| CARDIODAY (K130516) | Getemed Medizin- Und Informationstechnik AG | 2013-08-23 |
| SENSIS, SENSIS LITE (K131812) | Siemens Medi Cal Solutions, Inc. | 2013-07-25 |
| RHYTHMIA MAPPING SYSTEM (K130750) | Rhythmia Medical, Inc. | 2013-07-22 |
| ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE (K131045) | Cardiac Designs, LLC | 2013-05-29 |