| CorVista System® with PCWP Add-On (K253576) | Analytics For Life, Inc. | 2026-07-26 |
| EnSite™ X EP System (K262006) | Abbott Medical | 2026-07-15 |
| ScioCardio ECG Analysis Platform (K252978) | Synergen Technology Labs, LLC | 2026-07-09 |
| ILR ECG Analyzer (IM007) (K253463) | Implicity, Inc. | 2026-07-02 |
| NorthStar Mapping System (MAP01 or MAP01-01) (K261119) | Imricor Medical Systems, Inc. | 2026-06-30 |
| OneStim-DUO Cardiac Stimulator (MP5003-4CO) (K253088) | Micropace Pty, Ltd. | 2026-06-12 |
| Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) (K261329) | Centerline Biomedical | 2026-06-10 |
| ZEUS Platform (FG0501US) (K252859) | iRhythm Technologies, Inc. | 2026-05-29 |
| EnSite™ X EP System (K260212) | ABBOTT MEDICAL | 2026-04-20 |
| ACORYS MAPPING SYSTEM (K253861) | Corify Care S.L | 2026-04-13 |
| Synchrony (K253473) | Stereotaxis, Inc. | 2026-04-01 |
| HemoSphere Nano Monitor (HSNANO1) (K253186) | Edwards Lifesciences, LLC | 2026-02-24 |
| CARTO™ 3 EP Navigation System V8.4 (K252972) | Biosense Webster, Inc. | 2026-02-20 |
| IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) (K254089) | Centerline Biomedical, Inc. | 2026-02-17 |
| Holter ECG and ABP system (HolterABP) (K251591) | Edan Instruments, Inc. | 2026-02-09 |
| SafeBeat Rx App (K251218) | SafeBeat Rx, Inc. | 2026-02-06 |
| NorthStar™ Mapping System (K252164) | Imricor Medical Systems | 2026-01-28 |
| CARTO™ 3 EP Navigation System V9.0 with PIU Plus (K254085) | Biosense Webster, Inc. | 2026-01-18 |
| STAR Apollo™ Mapping System (K253733) | Rhythm AI, Ltd. | 2025-12-19 |
| HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (K252533) | Edwards Lifesciences | 2025-12-18 |
| DeepRhythmAI (K253141) | Medicalgorithmics S.A. | 2025-12-11 |
| Vektor Computational ECG Mapping System (vMap®) (K252429) | Vektor Medical, Inc. | 2025-12-04 |
| LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub (K252645) | Philips Medical Systems Nederland B.V. | 2025-10-24 |
| CoroFlow Cardiovascular System (K252238) | Coroventis Research AB | 2025-10-24 |
| HemoSphere Stream Module (K253034) | Edwards Lifesciences | 2025-10-21 |
| EnSite™ X EP System (K252013) | ABBOTT MEDICAL | 2025-09-25 |
| Volta AF-Xplorer II (K251518) | Volta Medical | 2025-09-12 |
| EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) (K251463) | ABBOTT MEDICAL | 2025-09-04 |
| CARTO™ 3 EP Navigation System V8.1 (K252302) | Biosense Webster, Inc. | 2025-08-22 |
| EnSite™ X EP System (K251234) | ABBOTT MEDICAL | 2025-07-30 |
| HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) (K243781) | Edwards Lifesciences | 2025-07-23 |
| Globe® Pulsed Field System (K250747) | Kardium, Inc. | 2025-06-25 |
| PhysCade System (K250749) | Physcade, Inc. | 2025-06-04 |
| OptiMap™ System (K251344) | Boston Scientific Corporation | 2025-05-28 |
| DeepRhythmAI (K250932) | Medicalgorithmics S.A. | 2025-05-27 |
| Volta AF-Xplorer (K243812) | Volta Medical | 2025-05-09 |
| VitalRhythm (K242129) | Vitalconnect, Inc. | 2025-04-17 |
| Intra-Operative Positioning System (IOPS®) (K243842) | Centerline Biomedical, Inc. | 2025-03-06 |
| CER-S (K243312) | Cardiocalm Srl | 2025-02-20 |
| Affera Integrated Mapping System (K243892) | Medtronic, Inc. | 2025-01-17 |
| Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) (K243540) | Ge Medical Systems Information Technologies, Inc. | 2024-12-12 |
| Magnetic Localization Patch Kit (AFR-00021) (K243435) | Medtronic, Inc. | 2024-12-05 |
| DeepRhythmAI (K241197) | Medicalgorithmics S.A. | 2024-12-04 |
| Affera Integrated Mapping System; Impedance Localization Patch Kit (K241828) | Medtronic, Inc. | 2024-11-01 |
| Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) (K242133) | Centerline Biomedical, Inc. | 2024-10-11 |
| RHYTHMIA HDx™ Mapping System (K241227) | Boston Scientific Corporation | 2024-08-29 |
| HeartKey® Rhythm (K233755) | B-Secur Limited | 2024-08-16 |
| EnSite™ X EP System (K242016) | ABBOTT MEDICAL | 2024-08-09 |
| STAR Apollo™ Mapping System (K240509) | Rhythm AI, Ltd. | 2024-07-26 |
| Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) (K241243) | Centerline Biomedical, Inc. | 2024-07-24 |
| Merge Hemo, Model RCSV2 (K233326) | Merge Healthcare Incorporated | 2024-06-21 |
| LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub (K233853) | Philips Medical Systems Nederland B.V. | 2024-03-14 |
| Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) (K233943) | Medtronic, Inc. | 2024-03-08 |
| CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System (K231870) | Ge Medical Systems Information Technologies, Inc. | 2023-12-13 |
| NeuTrace EP Mapping System v.2.1 (K233160) | Anumana, Inc. | 2023-11-25 |
| HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One) (K232294) | Edwards Lifesciences, LLC | 2023-10-31 |
| Volta AF-Xplorer (K232616) | Volta Medical | 2023-09-27 |
| AVVIGO'+ Multi-Modality Guidance System (K230884) | Boston Scientific Corporation | 2023-09-26 |
| Sensis Vibe (VD15) (K223812) | Siemens Medical Solutions USA, Inc. | 2023-09-15 |
| CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) (K231207) | Biosense Webster, Inc. | 2023-09-07 |
| Smart Wedge algorithm (K230579) | Edwards Lifesciences, LLC | 2023-08-18 |
| EnSite™ X EP System (K231415) | ABBOTT MEDICAL | 2023-08-10 |
| ECGenius System (K223787) | Cath Vision Aps | 2023-08-04 |
| Nuubo Smart (K231620) | Smart Solutions Technologies SL | 2023-08-01 |
| FusedCO Algorithm (K231035) | Edwards Lifesciences, LLC | 2023-07-12 |
| AcQMap High Resolution Imaging and Mapping System (K231091) | Acutus Medical, Inc. | 2023-07-10 |
| Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) (K230309) | Centerline Biomedical, Inc. | 2023-06-21 |
| HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor (K223865) | Edwards Lifesciences, LLC | 2023-06-09 |
| AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub (K223918) | Philips Medical Systems Nederland B.V. | 2023-06-08 |
| Ablamap® System (K230008) | Ablacon, Inc. | 2023-06-08 |
| AcQMap® High Resolution Imaging and Mapping System (K230606) | Acutus Medical, Inc. | 2023-05-02 |
| CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 (K223733) | Biosense Webster, Inc. | 2023-02-16 |
| ZEUS System (K222389) | iRhythm Technologies, Inc. | 2023-02-15 |
| VX1+ (K223516) | Volta Medical | 2023-01-21 |
| EndoPATx (K211557) | Itamar Medical , Ltd. | 2022-12-29 |
| EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License (K223094) | ABBOTT MEDICAL | 2022-12-27 |
| STAR Apollo Mapping System (K220786) | Rhythm Al, Ltd. | 2022-12-01 |
| HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) (K221704) | Edwards Lifesciences, LLC | 2022-11-22 |
| HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable (K223127) | Edwards Lifeciences, LLC | 2022-11-07 |
| KODEX – EPD™ System 1.5.0 (K212493) | Philips Medical Systems Nederland, B.V. (Pmsn) | 2022-10-24 |
| AcQMap High Resolution Imaging and Mapping System (K222209) | Acutus Medical, Inc. | 2022-10-17 |
| EnSite X EP System (K221213) | Abbott | 2022-08-18 |
| CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) (K221112) | Biosense Webster, Inc. | 2022-08-17 |
| DeepRhythmAI (K210822) | Medicalgorithmics S.A. | 2022-07-27 |
| ZEUS System (Zio Watch) (K213409) | iRhythm Technologies, Inc. | 2022-07-19 |
| AcQMap High Resolution Imaging and Mapping System (K220784) | Acutus Medical, Inc. | 2022-07-01 |
| HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote (K213682) | Edwards Lifesciences, LLC | 2022-06-22 |
| ECGenius System (K220306) | Cath Vision Aps | 2022-05-03 |
| Ultiri Measurement System (K220243) | ABBOTT MEDICAL | 2022-04-30 |
| AliveCor QT Service (K212662) | AliveCor, Inc. | 2022-04-26 |
| CER-S (K213861) | Cardiocalm Srl | 2022-04-25 |
| Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX (K213972) | Ge Healthcare Information Technologies, Inc. | 2022-02-17 |
| Cardiovascular Suite 4.2.1 (K202094) | Quipu S.R.L | 2022-01-11 |
| EnSite X EP System (K213364) | ABBOTT MEDICAL | 2021-11-11 |
| Vektor Computational ECG Mapping System (vMap) (K211546) | Vektor Medical, Inc. | 2021-11-09 |
| IM007 (K210543) | Implicity, Inc. | 2021-11-03 |
| CARTO 3 EP Navigation System Version 7.2 (K213264) | Biosense Webster, Inc. | 2021-10-29 |
| EnSite X EP System (K212061) | Abbott | 2021-10-22 |
| AVVIGO Guidance System II (K212490) | Boston Scientific Corporation | 2021-10-20 |
| Ablamap Software (K203084) | Ablacon, Inc. | 2021-08-31 |