| LifeLens Physiological Monitor (K260157) | LifeLens Technologies, Inc. | 2026-07-09 |
| Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) (K252389) | Smwmed, Inc. | 2026-04-23 |
| VitaloJAK Clinic (Model 7100) (K253293) | Vitalograph , Ltd. | 2025-12-03 |
| Zio® monitor (DFG0001) (K243650) | iRhythm Technologies, Inc. | 2025-08-15 |
| AeviceMD (K243603) | Aevice Health Pte. , Ltd. | 2025-05-05 |
| AT-Patch (ATP-C130/ATP-C70) (K242583) | Atsens Co., Ltd. | 2025-05-02 |
| HiCardi+ H100 (K232670) | MEZOO Co., Ltd. | 2024-09-20 |
| S-Patch (S-Patch ExL) (K233906) | Wellysis Corp. | 2024-02-16 |
| ABPMpro (K231104) | Somnomedics GmbH | 2023-11-27 |
| Carnation Ambulatory Monitor (K233110) | Bardy Diagnostics, Inc. | 2023-11-22 |
| Holter ECG and ABP System (K230184) | Edan Instruments, Inc. | 2023-09-25 |
| S-Patch Ex Wearable ECG Patch (K231289) | Wellysis Corp. | 2023-08-30 |
| AeviceMD (K223382) | Aevice Health Pte. , Ltd. | 2023-07-07 |
| CardioSTAT® ECG Test Solution (K223049) | Icentia, Inc. | 2023-03-22 |
| eWave Monitor (K214073) | Wearlinq, Inc. | 2022-10-20 |
| AT-Patch ECG Analysis System (K203638) | Atsens Co., Ltd. | 2022-10-12 |
| QOCA Portable ECG Monitoring Device (K210179) | Quanta Computer, Inc. | 2022-08-02 |
| Strados Remote Electronic Stethoscope Platform (RESP) (K220893) | Strados Labs, Inc. | 2022-04-27 |
| LifeLens Wireless ECG Monitor (K203168) | LifeLens Technologies, Inc. | 2021-07-20 |
| Zio Monitor (K202359) | iRhythm Technologies, Inc. | 2021-05-21 |
| QardioCore (K201644) | Qardio, Inc. | 2021-02-28 |
| Carnation Ambulatory Monitor (CAM) (K210036) | Bardy Diagnostics, Inc. | 2021-02-05 |
| M5 Recorder (K202456) | Global Instrumentation, LLC | 2020-12-29 |
| Strados Remote Electronic Stethoscope Platform (RESP) (K201077) | Strados Labs | 2020-12-20 |
| Bioflux Software II (K201040) | Biotricity | 2020-07-29 |
| Carnation Ambulatory Monitor (K200870) | Bardy Diagnostics, Inc. | 2020-05-01 |
| Carnation Ambulatory Monitor (K192556) | Bardy Diagnostics, Inc. | 2019-10-17 |
| Carnation Ambulatory Monitor (K191471) | Bardy Diagnostics, Inc. | 2019-08-30 |
| Carnation Ambulatory Monitor (K191000) | Bardy Diagnostics, Inc. | 2019-05-16 |
| ECG recorder and Arrhythmia Detector (K173461) | Smart Solutions Technologies SL | 2018-08-03 |
| Portable ECG Monitor (ECG3) (K172862) | Andon Health Co, Ltd. | 2018-07-24 |
| ePatch (K171410) | Braemar Manufacturing, LLC | 2018-01-04 |
| Peerbridge Cor(TM) System (K171936) | Peerbridge Health, Inc. | 2017-09-27 |
| Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software (K162503) | Cardiac Insight, Inc. | 2017-03-24 |
| my Patch sl (K163535) | Dms-Service, LLC | 2017-02-22 |
| Bioflux Software (K162571) | Biotricity, Inc. | 2016-10-13 |
| myPatch-s (K160704) | Dms-Service, LLC | 2016-07-15 |
| Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System (K142468) | Cardiac Insight, Inc. | 2015-07-11 |
| ZIO SR ECG Monitoring Service (K143513) | iRhythm Technologies, Inc. | 2015-06-19 |
| Carnation Ambulatory Monitor (K143067) | Bardy Diagnostics, Inc. | 2014-12-22 |
| MYPATCH (K131190) | Dms-Service, LLC | 2013-10-29 |
| STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE (K130288) | Cardiac Insight, Inc. | 2013-05-29 |
| ZIO PATCH (K121319) | iRhythm Technologies, Inc. | 2012-07-18 |
| ZIO PATCH (K113862) | iRhythm Technologies, Inc. | 2012-02-06 |
| MYSENSE HEART (K113176) | Cardiac Science Corporation | 2011-12-21 |
| VITALOGRAPH MODEL 7100 - VITALOJAK (K110525) | Vitalograph (Ireland) , Ltd. | 2011-11-23 |
| GLOBALCARDIO (K111320) | Cardiocomm Solutions, Inc. | 2011-10-07 |
| KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER (K111745) | Card Guard Scientific Survival , Ltd. | 2011-08-01 |
| VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY (K111180) | Vasomedical, Inc. | 2011-06-28 |
| VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY (K111096) | Vasomedical, Inc. | 2011-06-24 |
| PULMOTRACK 5050 WHOLTER, MODEL 5050 (K101022) | Karmelsonix | 2010-07-09 |
| COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 (K092785) | Vasomedical, Inc. | 2010-04-02 |
| COR12+ (K091505) | Viasys Healthcare GmbH | 2009-06-10 |
| ZIO PATCH, MODEL Z100 (K090363) | iRhythm Technologies, Inc. | 2009-05-08 |
| VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C (K083820) | Vasomedical, Inc. | 2009-04-01 |
| PC-180 / PRINCE 180 EASY ECG MONITOR (K073152) | Shenzhen Creative Industry Co., Ltd. | 2008-01-10 |
| MEDILOGAR4, MEDILOGAR12 (K070818) | Tom Medical Entwicklungs GmbH | 2007-04-06 |
| DMS 300-7 (K062007) | Diagnostic Monitoring Software | 2006-08-16 |
| H12+ HOLTER RECORDER (K050896) | Mortara Instrument, Inc. | 2005-08-24 |
| MODIFICATION TO GLOBALCARDIO (K033037) | Cardiocomm Solutions, Inc. | 2003-10-31 |
| PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A (K032103) | Philips Medical Systems | 2003-07-22 |
| CARDIO ID+(RZ153+) (K022540) | Rozinn Electronics, Inc. | 2002-10-24 |
| GLOBAL ECG MANAGEMENT SYSTEM (GEMS) (K022297) | Cardiocomm Solutions, Inc. | 2002-09-27 |
| KING OF HEARTS EXPRESS + AF MONITOR (K020825) | Card Guard Scientific Survival , Ltd. | 2002-04-05 |
| GLOBALCARDIO (K013354) | Cardiocomm Solutions, Inc. | 2002-01-31 |
| DR180+OXY (K004007) | North East Monitoring, Inc. | 2001-01-25 |
| LIFECARD CF COMPACT RECORDER (K001025) | Reynolds Medical , Ltd. | 2000-04-19 |
| CARDIOLIGHT (K982448) | Capintec, Inc. | 1999-06-11 |
| OMNICORDER, MODEL 464 (K990027) | Del Mar Avionics | 1999-02-09 |
| MERCATOR (K982384) | Harley Street Software , Ltd. | 1999-01-27 |
| MICROVIT MT-100 (K973735) | Schiller America, Inc. | 1998-08-25 |
| M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION (K974420) | Hewlett-Packard Co. | 1998-02-19 |
| 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER (K971670) | Galix Biomedical Instrumentation, Inc. | 1998-01-29 |
| DM-400 HOLTER ECG CASSETTE RECORDER (K970298) | Diagnostic Monitoring | 1997-08-20 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP (K971604) | Alexander Mfg. Co. | 1997-07-28 |
| MEDILOG FD4 (K970902) | Oxford Instruments Medical Systems | 1997-05-05 |
| HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) (K963174) | Del Mar Avionics | 1997-03-13 |
| MODEL 700 (K944180) | Memtec Corp. | 1997-03-07 |
| NORTHEAST MONITORING DR180 (K960925) | North East Monitoring, Inc. | 1996-07-31 |
| VITALOGRAPH 2110 SOFTWARE INTERFACE (K950854) | Vitalograph , Ltd. | 1995-10-12 |
| HOLTER PACERCORDER(R) (K950020) | Del Mar Avionics | 1995-08-17 |
| SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM (K951605) | Spacelabs, Inc. | 1995-07-14 |
| SONICAID MODEL MR-63 AMBULATORY ECG RECORDER (K943862) | Oxford Instruments Medical Systems | 1995-06-07 |
| HOLTER SSR DIGICORDER(TM) (K942653) | Del Mar Avionics | 1995-05-10 |
| BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER (K945130) | Braemar Corp. | 1995-04-12 |
| DIGITAL HOLTER RECORDER (K942781) | Agilent Technologies | 1995-01-24 |
| HEARTPRINT (K942862) | Medata, Inc. | 1995-01-18 |
| TRACKER 2/TRACKER 3 HOLTER RECORDER (K943278) | Reynolds Medical , Ltd. | 1994-10-20 |
| ALTAIR 6100 CASSETTE RECORDER (K942438) | Burdick, Inc. | 1994-08-05 |
| SCOLE 300 ECG RECORDER (K923664) | Scole Engineering Co. | 1994-01-13 |
| R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211 (K934660) | R & D Batteries, Inc. | 1993-12-03 |
| MULTITRAK-PLUS (K930894) | Zymed Medical Instrumentation | 1993-11-01 |
| HRV 4000EM (K932929) | All-Tronics Medical Systems | 1993-09-09 |
| UNISCAN 24 ECG ROCORDER (K920572) | Uniscan , Ltd. | 1992-04-06 |
| GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 (K921068) | Datrix | 1992-03-30 |
| WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM (K913600) | Ralin Laboratories, Inc. | 1991-10-16 |
| CARD GUARD, MODELS CG-6000 & CG-7000 (K910884) | Card Guard Scientific Survival , Ltd. | 1991-10-16 |
| SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION (K913038) | Spacelabs, Inc. | 1991-10-04 |
| GALIX MA-6C HOLTER CASSETTE RECORDER (K904177) | Galix Instrumentacion Biomedica | 1991-09-20 |
| GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER (K904176) | Galix Instrumentacion Biomedica | 1991-09-20 |