| 2026-06-08 | K260332 | EchoNext | Pathwai, Inc. | Cardiovascular |
| 2026-05-29 | K252859 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | Cardiovascular |
| 2026-05-22 | DEN250057 | PCWP Analysis Software | Cardiosense, Inc. | Cardiovascular |
| 2026-04-17 | K252945 | Novasight Hybrid System | Conavi Medical, Inc. | Cardiovascular |
| 2026-04-07 | K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | Anumana, Inc. | Cardiovascular |
| 2026-03-28 | K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. | Cardiovascular |
| 2026-03-12 | K252089 | Tyto Stethoscope (G3) | Tyto Care , Ltd. | Cardiovascular |
| 2026-02-20 | K252972 | CARTO™ 3 EP Navigation System V8.4 | Biosense Webster, Inc. | Cardiovascular |
| 2026-02-13 | K250233 | PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | Cardiovascular |
| 2026-02-06 | K252076 | Kneevoice Cartilage Evaluation System (750-3600-001) | Kneevoice, Inc. | Cardiovascular |
| 2026-02-06 | K251218 | SafeBeat Rx App | SafeBeat Rx, Inc. | Cardiovascular |
| 2026-02-02 | K251200 | Vital Signs | Oxehealth Limited | Cardiovascular |
| 2026-01-23 | K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | Cardiovascular |
| 2026-01-22 | K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | Cardiovascular |
| 2026-01-09 | K252589 | Corvair Monza | AliveCor, Inc. | Cardiovascular |
| 2025-12-19 | K252284 | eMurmur Heart AI | Csd Labs | Cardiovascular |
| 2025-12-18 | K253516 | Assert-IQ (DM5100) | Abbott Medical | Cardiovascular |
| 2025-12-16 | K252204 | prolaio eVO2peak Module (Version 1.0) | Prolaio, Inc. | Cardiovascular |
| 2025-12-11 | K253141 | DeepRhythmAI | Medicalgorithmics S.A. | Cardiovascular |
| 2025-11-25 | K250635 | FEops HEARTguide Simulation Application | Feops NV | Cardiovascular |
| 2025-11-21 | K251293 | CardioVision | Icardio.Ai | Cardiovascular |
| 2025-10-28 | P220012/S059 | Aurora EV ICD (DVEA3E4) | Medtronic, Inc. | Cardiovascular |
| 2025-10-28 | P980016/S939 | Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I | Medtronic Cardiac Rhythm Disease Management | Cardiovascular |
| 2025-09-19 | K250649 | Bunkerhill ECG-EF | BunkerHill Health | Cardiovascular |
| 2025-09-17 | K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Abbott | Cardiovascular |
| 2025-09-12 | K251518 | Volta AF-Xplorer II | Volta Medical | Cardiovascular |
| 2025-09-12 | K252595 | Stethophone Pro | Sparrow Acoustics, Inc. | Cardiovascular |
| 2025-09-11 | K250507 | Hypertension Notification Feature (HTNF) | Apple Inc. | Cardiovascular |
| 2025-08-27 | K243687 | Vital Signs | Oxehealth Limited | Cardiovascular |
| 2025-08-12 | K251494 | Eko Foundation Analysis Software with Transformers (EFAST) | Eko Health, Inc. | Cardiovascular |
| 2025-08-06 | K250569 | Cardiologs Holter Platform | Philips France Commercial | Cardiovascular |
| 2025-07-28 | K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | Cardiovascular |
| 2025-07-18 | K250902 | HeartFlow Analysis | HeartFlow, Inc. | Cardiovascular |
| 2025-07-15 | K250119 | Tempus ECG-Low EF | Tempus AI, Inc. | Cardiovascular |
| 2025-06-20 | K250151 | Us2.ca | Eko.Ai Pte Ltd. D/B/A Us2.Ai | Cardiovascular |
| 2025-06-15 | K240795 | Withings ECG App | Withings | Cardiovascular |
| 2025-06-06 | K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.R.L. | Cardiovascular |
| 2025-06-04 | K250749 | PhysCade System | PhysCade, Inc. | Cardiovascular |
| 2025-05-27 | K250932 | DeepRhythmAI | Medicalgorithmics S.A. | Cardiovascular |
| 2025-05-21 | K243866 | InVision Precision Cardiac Amyloid | InVision Medical Technology Corporation | Cardiovascular |
| 2025-05-09 | K243812 | Volta AF-Xplorer | Volta Medical | Cardiovascular |
| 2025-05-02 | K242583 | AT-Patch (ATP-C130/ATP-C70) | ATsens Co.,Ltd. | Cardiovascular |
| 2025-04-30 | P230022 | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati | Element Science, Inc. | Cardiovascular |
| 2025-04-17 | K242129 | VitalRhythm | VitalConnect, Inc. | Cardiovascular |
| 2025-02-25 | K242967 | Loss of Pulse Detection | Fitbit | Cardiovascular |
| 2024-12-04 | K241197 | DeepRhythmAI | Medicalgorithmics S.A. | Cardiovascular |
| 2024-11-18 | K241633 | Informed Vital Core Application (IVC App) | Mindset Medical, Inc. | Cardiovascular |
| 2024-11-15 | K240860 | EchoGo Amyloidosis (1.0) | Ultromics Limited | Cardiovascular |
| 2024-09-23 | K240013 | EchoGo Heart Failure (2.0) | Ultromics Limited | Cardiovascular |
| 2024-08-16 | K233755 | HeartKey® Rhythm | B-Secur Limited | Cardiovascular |
| 2024-08-02 | K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences, LLC | Cardiovascular |
| 2024-06-21 | K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | AgileMD, Inc. | Cardiovascular |
| 2024-06-21 | K233549 | Tempus ECG-AF | Tempus AI, Inc. | Cardiovascular |
| 2024-06-07 | K232035 | Impala | AliveCor, Inc. | Cardiovascular |
| 2024-06-07 | K231010 | Corvair | AliveCor, Inc. | Cardiovascular |
| 2024-05-07 | K233864 | ASSURE Wearable ECG | Kestra Medical Technologies, Inc. | Cardiovascular |
| 2024-04-05 | K233666 | CorVista System with PH Add-On | Analytics for Life, Inc. | Cardiovascular |
| 2024-04-05 | K233249 | APPRAISE-HRI | The Surgeon General, Department of the Army (TSG-DA) | Cardiovascular |
| 2024-03-28 | K233409 | Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. | Cardiovascular |
| 2024-01-13 | K233216 | CLEWICU System | Clew Medical Ltd. | Cardiovascular |
| 2023-12-06 | K233562 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | Cardiovascular |
| 2023-10-25 | K230842 | SignalHF (IM008) | Implicity Inc. | Cardiovascular |
| 2023-10-06 | K223905 | Vivio® LVEDP System | Avicena, LLC | Cardiovascular |
| 2023-09-28 | K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | Cardiovascular |
| 2023-09-27 | K232616 | Volta AF-Xplorer | Volta Medical | Cardiovascular |
| 2023-09-08 | K231335 | Cleerly ISCHEMIA | Cleerly, Inc | Cardiovascular |
| 2023-09-08 | K232686 | CorVista® System | CorVista Health, Inc. | Cardiovascular |
| 2023-09-07 | K231207 | CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | Biosense Webster, Inc. | Cardiovascular |
| 2023-09-01 | K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK) | FaceHeart Corp. | Cardiovascular |
| 2023-08-23 | K230812 | Withings Scan Monitor 2.0 | Withings | Cardiovascular |
| 2023-08-03 | DEN230003 | Viz HCM | Viz.ai, Inc. | Cardiovascular |
| 2023-07-26 | K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | Cardiovascular |
| 2023-07-21 | K231173 | Irregular Rhythm Notification Feature (IRNF) | Apple Inc. | Cardiovascular |
| 2023-07-12 | K230823 | AusculThing ACC | AusculThing Oy | Cardiovascular |
| 2023-05-25 | K230273 | Saranas Early Bird Bleed Monitoring System | Saranas Inc. | Cardiovascular |
| 2023-05-02 | K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co., Ltd | Cardiovascular |
| 2023-04-26 | K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | Medtronic, Inc. | Cardiovascular |
| 2023-04-05 | K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | Medtronic, Inc. | Cardiovascular |
| 2023-03-17 | K223073 | Alio | Alio, Inc. | Cardiovascular |
| 2023-02-15 | K222389 | ZEUS System | iRhythm Technologies, Inc. | Cardiovascular |
| 2023-01-21 | K223516 | VX1+ | Volta Medical | Cardiovascular |
| 2022-12-01 | K220786 | STAR Apollo Mapping System | Rhythm Al, Ltd | Cardiovascular |
| 2022-10-31 | P210015 | Avive Automated External Defibrillator (AED) System | Avive Solutions, Inc. | Cardiovascular |
| 2022-10-14 | K213857 | HeartFlow Analysis | HeartFlow, Inc. | Cardiovascular |
| 2022-08-25 | K221962 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | Cardiovascular |
| 2022-07-27 | K210822 | DeepRhythmAI | Medicalgorithmics S.A. | Cardiovascular |
| 2022-07-19 | K213409 | ZEUS System (Zio Watch) | iRhythm Technologies, Inc. | Cardiovascular |
| 2022-07-19 | K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor | Verily Life Sciences LLC | Cardiovascular |
| 2022-07-14 | K221203 | AHI System | Fifth Eye Inc. | Cardiovascular |
| 2022-06-29 | K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | Cardiovascular |
| 2022-06-03 | K213971 | Atrial Fibrillation History Feature | Apple Inc. | Cardiovascular |
| 2022-05-31 | K220766 | eMurmur Heart AI | CSD Labs GmbH | Cardiovascular |
| 2022-04-29 | K220899 | Oxehealth Vital Signs | Oxehealth Limited | Cardiovascular |
| 2022-04-26 | K212662 | AliveCor QT Service | AliveCor, Inc. | Cardiovascular |
| 2022-04-01 | K213657 | DEEPVESSEL FFR | KeyaMed NA Inc. | Cardiovascular |
| 2021-12-03 | K212219 | AHI System | Fifth Eye Inc. | Cardiovascular |
| 2021-11-03 | K210543 | IM007 | Implicity, Inc. | Cardiovascular |
| 2021-10-22 | K212516 | IRNF App | Apple Inc. | Cardiovascular |
| 2021-07-20 | K211906 | Vital Signs | Oxehealth Limited | Cardiovascular |
| 2021-06-11 | K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | Cardiovascular |
| 2021-05-21 | K202527 | Zio ECG Utilization Software (ZEUS) System | iRhythm Technologies, Inc. | Cardiovascular |
| 2021-04-01 | DEN200038 | Gili Pro BioSensor (also known as “Gili BioSensor System”) | ContinUse Biometrics Ltd. | Cardiovascular |
| 2021-03-26 | DEN200019 | Oxehealth Vital Signs | Oxehealth Limited | Cardiovascular |
| 2021-03-01 | DEN200022 | Analytic for Hemodynamic Instability (AHI) | Fifth Eye Inc. | Cardiovascular |
| 2021-01-09 | K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | CLEW Medical Ltd. | Cardiovascular |
| 2021-01-08 | K203329 | HeartFlow Analysis | HeartFlow, Inc. | Cardiovascular |
| 2020-11-12 | K201985 | KardiaAI | AliveCor, Inc. | Cardiovascular |
| 2020-10-09 | K193631 | Stethee Pro 1, Stethee Pro Software System | M3DICINE Pty Ltd. | Cardiovascular |
| 2020-09-16 | K201298 | VX1 | Volta Medical | Cardiovascular |
| 2020-09-02 | K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant Inc. | Cardiovascular |
| 2020-03-26 | K192732 | BodyGuardian Remote Monitoring System | Preventice Technologies, Inc. | Cardiovascular |
| 2020-03-20 | K200036 | AI-ECG Tracker | Shenzhen Carewell Electronics Co., Ltd. | Cardiovascular |
| 2020-01-17 | K192415 | Study Watch with Irregular Pulse Monitor | Verily Life Sciences LLC | Cardiovascular |
| 2020-01-15 | K192004 | Eko Analysis Software | Eko Devices Inc | Cardiovascular |
| 2019-12-09 | K192442 | FFRangio | CathWorks Ltd | Cardiovascular |
| 2019-11-25 | K190529 | SOZO | ImpediMed Limited | Cardiovascular |
| 2019-11-01 | K190334 | MIMOSA Imager | MIMOSA Diagnostics Inc | Cardiovascular |
| 2019-09-11 | K183370 | PeraMobile and PeraWatch | PeraHealth, Inc. | Cardiovascular |
| 2019-08-23 | K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | Cardiovascular |
| 2019-08-15 | K190925 | HeartFlow FFRct Analysis | HeartFlow, Inc. | Cardiovascular |
| 2019-08-15 | K183282 | Biovitals Analytics Engine | Biofourmis Singapore Pte. Ltd | Cardiovascular |
| 2019-07-10 | K183322 | physIQ Heart Rhythm and Respiratory Module | physIQ, Inc | Cardiovascular |
| 2019-05-21 | K183646 | Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure | Edwards Lifeciences, LLC | Cardiovascular |
| 2019-04-17 | K181988 | eMurmur ID | CSD Labs GmbH | Cardiovascular |
| 2019-03-29 | K181352 | Loop System | Spry Health, Inc. | Cardiovascular |
| 2019-03-11 | K181823 | KardiaAI | AliveCor, Inc. | Cardiovascular |
| 2019-03-07 | K182344 | RhythmAnalytics | Biofourmis Singapore Pte. Ltd. | Cardiovascular |
| 2019-02-16 | K183704 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant Inc. | Cardiovascular |
| 2019-01-17 | K182456 | Study Watch | Verily Life Sciences LLC | Cardiovascular |
| 2018-12-19 | K182149 | FFRangio System | CathWorks Ltd | Cardiovascular |
| 2018-12-14 | K182790 | Cardio-TriTest v6.5 | Cardio-Phoenix Inc. | Cardiovascular |
| 2018-12-06 | K182035 | FFRct | HeartFlow, Inc | Cardiovascular |
| 2018-11-19 | K180432 | AI-ECG Platform | Shenzhen Carewell Electronics., Ltd | Cardiovascular |
| 2018-09-28 | K173872 | FibriCheck | Qompium nv | Cardiovascular |
| 2018-08-29 | K181502 | Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, Inc. | Cardiovascular |
| 2018-05-01 | K172959 | PeraServer and PeraTrend | PeraHealth, Inc. | Cardiovascular |
| 2018-04-16 | K180126 | SOZO | ImpediMed Limited | Cardiovascular |
| 2018-03-16 | DEN160044 | Acumen Hypotension Prediction Index (HPI) Feature Software | Edwards Lifesciences LLC | Cardiovascular |
| 2018-01-04 | K171056 | WAVE Clinical Platform | Excel Medical Electronics, LLC | Cardiovascular |
| 2017-12-22 | K172507 | SOZO | ImpediMed Limited | Cardiovascular |
| 2017-11-07 | K163694 | Rooti Rx ECG Event Recorder, Rooti Link APP Software | Rooti Labs Ltd. | Cardiovascular |
| 2017-09-27 | K171936 | Peerbridge Cor(TM) System | Peerbridge Health INc. | Cardiovascular |
| 2017-08-17 | K163339 | SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 | SPECTRALMD, INC. | Cardiovascular |
| 2017-08-11 | K172122 | SOZO | ImpediMed Limited | Cardiovascular |
| 2017-06-26 | K170568 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | Cardiovascular |
| 2017-02-23 | K162855 | Reveal LINQ | Medtronic, Inc. | Cardiovascular |
| 2016-10-19 | K160401 | Tyto Stethoscope | Tyto Care Ltd. | Cardiovascular |
| 2016-08-24 | K161772 | FFRct | HEARTFLOW, INC. | Cardiovascular |
| 2016-07-15 | K160016 | Steth IO | STRATOSCIENTIFIC, INC. | Cardiovascular |
| 2016-01-13 | K152733 | FFRct | HEARTFLOW, INC. | Cardiovascular |
| 2015-06-11 | K142512 | Personalized Physiology Analytics Engine software | VGBio, Inc (DBA PhysIQ) | Cardiovascular |
| 2013-09-04 | K131044 | SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION | DIACOUSTIC MEDICAL DEVICES (PTY) LTD. | Cardiovascular |
| 2012-07-27 | K121617 | SENSICARDIAC | DIACOUSTIC MEDICAL (PTY) | Cardiovascular |
| 2008-07-17 | K081140 | VISENSIA | OBS MEDICAL | Cardiovascular |