| K260212 | EnSite X EP System | ABBOTT MEDICAL | 2026-04-20 |
| K253861 | ACORYS MAPPING SYSTEM | Corify Care S.L | 2026-04-13 |
| K253473 | Synchrony | Stereotaxis, Inc. | 2026-04-01 |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026-02-24 |
| K252972 | CARTO 3 EP Navigation System V8.4 | Biosense Webster, Inc. | 2026-02-20 |
| K254089 | 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) | Centerline Biomedical, Inc. | 2026-02-17 |
| K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026-02-09 |
| K251218 | SafeBeat Rx App | SafeBeat Rx, Inc. | 2026-02-06 |
| K252164 | NorthStar Mapping System | Imricor Medical Systems | 2026-01-28 |
| K254085 | CARTO 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. | 2026-01-18 |
| K253733 | STAR Apollo Mapping System | Rhythm AI, Ltd. | 2025-12-19 |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025-12-18 |
| K253141 | DeepRhythmAI | Medicalgorithmics S.A. | 2025-12-11 |
| K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | 2025-12-04 |
| K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | 2025-10-24 |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | 2025-10-24 |
| K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025-10-21 |
| K252013 | EnSite X EP System | ABBOTT MEDICAL | 2025-09-25 |
| K251518 | Volta AF-Xplorer II | Volta Medical | 2025-09-12 |
| K251463 | EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) | ABBOTT MEDICAL | 2025-09-04 |
| K252302 | CARTO 3 EP Navigation System V8.1 | Biosense Webster, Inc. | 2025-08-22 |
| K251234 | EnSite X EP System | ABBOTT MEDICAL | 2025-07-30 |
| K243781 | 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) | Edwards Lifesciences | 2025-07-23 |
| K250747 | Globe® Pulsed Field System | Kardium, Inc. | 2025-06-25 |
| K250749 | PhysCade System | Physcade, Inc. | 2025-06-04 |
| K251344 | OptiMap System | Boston Scientific Corporation | 2025-05-28 |
| K250932 | DeepRhythmAI | Medicalgorithmics S.A. | 2025-05-27 |
| K243812 | Volta AF-Xplorer | Volta Medical | 2025-05-09 |
| K242129 | VitalRhythm | Vitalconnect, Inc. | 2025-04-17 |
| K243842 | Intra-Operative Positioning System (IOPS®) | Centerline Biomedical, Inc. | 2025-03-06 |