| PreemptiveAI Clinical SDK (K250233) | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | 2026-02-13 |
| HeartBeam AIMIGo with 12-L ECG Synthesis Software System (K250258) | Heartbeam, Inc. | 2025-12-08 |
| MEMO Patch M (MPT-E08R-UNC01) (K243438) | Huinno Co., Ltd. | 2025-12-05 |
| Hexoskin Medical System (7100-00016) (K243981) | Carre Technologies, Inc. | 2025-11-18 |
| VitalSigns 1-Lead Holter (VSH101) (K243003) | VitalSigns Technology Co., Ltd. | 2025-06-17 |
| QT ECG (QTERD100) (K233521) | QT Medical, Inc. | 2023-12-06 |
| V-Patch Cardiac Monitor (K222842) | Shandong Corecare Technology Limited | 2022-10-20 |
| QT ECG (K220795) | QT Medical, Inc. | 2022-09-26 |
| Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor (K213357) | Verily Life Sciences, LLC | 2022-07-19 |
| KardiaMobile 6L (K220350) | AliveCor, Inc. | 2022-05-25 |
| KardiaMobile Card (K211668) | AliveCor, Inc. | 2021-11-30 |
| SimpleSENSE Platform (K212160) | Nanowear, Inc. | 2021-09-22 |
| KardiaMobile 6L (K210753) | AliveCor, Inc. | 2021-06-30 |
| SimpleSENSE (K201669) | Nanowear, Inc. | 2020-11-06 |
| eCordum Cardiac Monitor (eCordum CM) (K193296) | Ecordum, Inc. | 2020-10-30 |
| Halo AF Detection System (K201208) | Livmor | 2020-09-23 |
| KardiaMobile, KardiaStation (K191406) | AliveCor, Inc. | 2020-01-24 |
| Study Watch with Irregular Pulse Monitor (K192415) | Verily Life Sciences, LLC | 2020-01-17 |
| Triangle System (K183319) | AliveCor, Inc. | 2019-05-10 |
| KardiaMobile, KardiaStation (K182396) | AliveCor, Inc. | 2019-04-12 |
| HeartCheck Cardi Beat ECG Monitor with GEMS Mobile (K181310) | Cardiocomm Solutions, Inc. | 2019-02-22 |
| RX-1 Rhythm Express Remote Cardiac Monitoring System (K183704) | VivaQuant, Inc. | 2019-02-16 |
| Coala Heart Monitor (K182040) | Coala Life AB | 2019-02-08 |
| Study Watch (K182456) | Verily Life Sciences, LLC | 2019-01-17 |
| Prizma (K173589) | G-Medical Innovations , Ltd. | 2018-11-30 |
| FibriCheck (K173872) | Qompium NV | 2018-09-28 |
| CARDIOSKIN (K173248) | Bioserenity Sas | 2018-08-11 |
| QT ECG (K180157) | QT Medical, Inc. | 2018-05-04 |
| BioFlux Device (K172311) | Biotricity, Inc. | 2017-12-15 |
| Kardia Band System (K171816) | AliveCor, Inc. | 2017-11-16 |
| ECG SENTINEL System (K172801) | Cardiomedix, Inc. | 2017-10-18 |
| ECG Check - Universal, ECG Check - Universal Plus (K170506) | Cardiac Designs, Inc. | 2017-10-02 |
| Prizma (K170181) | G-Medical Innovations , Ltd. | 2017-09-01 |
| SimplECG (K161431) | Nanowear, Inc. | 2016-11-30 |
| Vitaphone Tele ECG Loop Recorder (K151013) | Vitasystems GmbH | 2015-04-30 |
| eMotion Faros ECG Mobile (K143032) | Mega Electronics , Ltd. | 2015-03-29 |
| Master Caution Device MCD (K142476) | Healthwatch , Ltd. | 2015-02-17 |
| AliveCor Heart Monitor (K142743) | AliveCor, Inc. | 2015-01-27 |
| AliveCor Heart Monitor (K142672) | AliveCor, Inc. | 2014-12-03 |
| PHYSIOGLOVE ET SYSTEM (K133703) | Commwell R&D , Ltd. | 2014-08-18 |
| ALIVECOR HEART MONITOR (K140933) | AliveCor, Inc. | 2014-08-15 |
| RHYTHMSTAR SYSTEM (K141813) | RhythMedix, LLC | 2014-08-05 |
| CLOUDEKG (K130878) | Makromed, Inc. | 2014-04-04 |
| MELYS ATRIAL FIBRILLATION SCREENING MONITOR (K132206) | Advanced Fluidics, LLC | 2014-03-19 |
| EMOTION ECG MOBILE (K131699) | Mega Electronics , Ltd. | 2013-11-26 |
| EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) (K121628) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013-06-25 |
| ECG CHECK (K122184) | Cardiac Designs, LLC | 2013-02-14 |
| SMARTHEART (K113514) | Shl Telemedicine International , Ltd. | 2012-02-22 |
| VITAPHONE. MODEL 100 BT (K100383) | Vitasystems GmbH | 2010-04-20 |
| RAISIN PERSONAL MONITOR (K093976) | Proteus Biomedical, Inc. | 2010-03-25 |
| HEALTHEPOD (K083174) | Card Guard Scientific Survival , Ltd. | 2009-12-17 |
| CLUE MEDICAL AND CLUE MEDICAL BASIC (K083630) | Telovital GmbH Telemedizin | 2009-04-23 |
| HEARTRAK SMART ECAT (K083535) | Universal Medical, Inc. | 2008-12-15 |
| TEMPUSIC PATIENT MONITOR (K082718) | Remote Diagnostic Technologies , Ltd. | 2008-10-10 |
| BT3/6, BT12 (K082077) | Corscience GmbH & Co. KG | 2008-09-02 |
| CARDIOSEN'C (K080047) | Shl Telemedicine International , Ltd. | 2008-07-11 |
| ECARD AND CCARD (K081471) | iRhythm Technologies, Inc. | 2008-06-24 |
| HEARTRAK AF (K071130) | Universal Medical, Inc. | 2008-05-14 |
| HEARTEVENT, MODEL AT (K072385) | Diagnostic Devices Pty, Ltd. | 2008-01-11 |
| FIDELITY 200 CARDIAC EVENT RECORDER (K071228) | Signalife, Inc. | 2007-11-21 |
| RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER (K063609) | Shl Telemedicine International , Ltd. | 2007-09-12 |
| SENTINEL (K062397) | Del Mar Reynolds Medical, Ltd. | 2007-01-25 |
| TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + (K061780) | Rozinn Electronics, Inc. | 2006-09-15 |
| CG-6108 ARRHYTHMIA ECG EVENT RECORDER (K060911) | Card Guard Scientific Survival , Ltd. | 2006-08-22 |
| PEPER (K060297) | Medical Monitors, Ltd. | 2006-08-02 |
| PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES (K061977) | Pinmed, Inc. | 2006-07-21 |
| AFIBALERT ATRIAL FIBRILLATION DETECTOR (K052767) | Lechnologies Research, Inc. | 2006-06-23 |
| LOOP RECORDER VITAPHONE, 3100 SERIES (K053378) | Tms Telemedizinische Systeme GmbH | 2006-02-23 |
| CG-7000DX-BT ECG RECORDER/TRANSMITTER (K052556) | Card Guard Scientific Survival , Ltd. | 2006-01-09 |
| VITALCAREGIVING SYSTEM (K051544) | Advanced Monitoring Caregiving, Inc. | 2005-10-07 |
| CARDIONAVIGATOR + (K051960) | Del Mar Reynolds Medical, Ltd. | 2005-08-19 |
| MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370 (K050951) | Cibernet Systems Corp. | 2005-07-19 |
| PMP4 MEDICAL WEB CENTER (K050940) | Card Guard Scientific Survival , Ltd. | 2005-07-01 |
| SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS (K050670) | Tms Telemedizinische Systeme GmbH | 2005-03-30 |
| PMP4 SELFCHECK ECG (K042254) | Card Guard Scientific Survival , Ltd. | 2005-01-13 |
| VST3 (K040942) | Biowatch Medical, Inc. | 2004-09-15 |
| E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER (K042022) | Datrix, Inc. Dba of Jon Barron, Inc. | 2004-08-12 |
| REMOTENURSE PATIENT MONITORING SYSTEM (K041308) | Webvmc, LLC | 2004-06-28 |
| TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 (K033410) | Remote Diagnostic Technologies , Ltd. | 2004-03-05 |
| HEARTRAK SMART AT/HEARTRAK SMART2 (K033451) | Universal Medical, Inc. | 2004-02-05 |
| HEART 2006 (K032736) | Aerotel Medical Systems (1998) , Ltd. | 2003-10-03 |
| TELZUIT CARDIAC MONITORING SYSTEM (K031229) | Telzuit Technologies, Inc. | 2003-07-09 |
| PER, MODEL MEMO (K030218) | Medical Monitors Pty., Ltd. | 2003-06-23 |
| MEDSTAR SYSTEM, MODELS 533-300 (K020534) | Cybernet Medical | 2003-02-11 |
| CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM (K023689) | Card Guard Scientific Survival , Ltd. | 2003-01-17 |
| TM2005 PERSONAL MEDICAL PHONE CENTER (K024365) | Card Guard Scientific Survival , Ltd. | 2003-01-15 |
| HEARTONE EVENT RECORDER AND TRANSMITTER (K023418) | Aerotel Medical Systems (1998) , Ltd. | 2002-11-06 |
| HEARTLINE RECEIVING STATION (K022073) | Aerotel Medical Systems (1998) , Ltd. | 2002-07-24 |
| NETLINK/NETSCAN (K020213) | Rozinn Electronics, Inc. | 2002-04-05 |
| TM2000, MODEL 1 (K013879) | Card Guard Scientific Survival , Ltd. | 2002-02-01 |
| ECG HOME (K012012) | H&C Medical Devices Spa | 2002-01-17 |
| TM2000 EASYTRACE PLUS RECEIVING CENTER (K013175) | Card Guard Scientific Survival , Ltd. | 2001-10-30 |
| CG-2211 SELFCHECK ECG TRANSMITTER (K012223) | Card Guard Scientific Survival , Ltd. | 2001-09-10 |
| CG-3250 MINIRECEIVER (K012187) | Card Guard Scientific Survival , Ltd. | 2001-08-14 |
| PACEART TX3 CARDIAC EVENT RECORDER (K012407) | Paceart, Inc. | 2001-08-14 |
| CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM (K011345) | Reynolds Medical , Ltd. | 2001-07-20 |
| HEARTCARD, MODEL 5258 (K010945) | Instromedix | 2001-06-12 |
| REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) (K010791) | Adsis , Ltd. | 2001-06-08 |
| TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 (K010436) | Remote Diagnostic Technologies , Ltd. | 2001-05-14 |
| BRIDGE III RECEIVER (K010794) | Meridian Medical Technologies , Ltd. | 2001-05-10 |