| BodyGuardian Remote Monitoring System (BGRMS v3.0) (K243349) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | 2026-01-23 |
| MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (K250356) | Infobionic, Inc. | 2025-07-29 |
| Zio AT® device (A100A1001) (K240177) | iRhythm Technologies, Inc. | 2024-10-30 |
| MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System (K230265) | Infobionic, Inc. | 2023-10-06 |
| SmartCardia 7L Platform (K231276) | Smartcardia SA | 2023-08-30 |
| Unified Arrhythmia Diagnostic System PocketECG IV (K193104) | Medicalgorithmics S.A. | 2020-04-09 |
| BodyGuardian Remote Monitoring System (K192732) | Preventice Technologies, Inc. | 2020-03-26 |
| Patient Assistant Model PA97000 (K190574) | Medtronic, Inc. | 2019-09-24 |
| Liba3 System (K182532) | National Cardiac, Inc. | 2019-05-15 |
| MobileECG 2 BT (K181658) | Memtec Corporation | 2019-03-26 |
| Medicalgorithmics Unified Cardiac Rehabilitation System (K173969) | Medicalgorithmics S.A. | 2018-07-11 |
| Epicardia Anywhere (K173170) | Medicomp, Inc. | 2018-01-10 |
| Braemar Telemetry Patch System (K153473) | Braemar Manufacturing, LLC | 2016-07-22 |
| EMMa Electronic Monitoring Management (K153477) | Vitasystems GmbH | 2016-05-25 |
| Matrix Mini ECG Monitor (K152701) | Global Instrumentation, LLC | 2016-04-22 |
| Nihon Kohden Afib Detection Program QP-039P (K152305) | Nihon Kohden Corporation | 2016-04-08 |
| Vital Signs Patch System (K151835) | Lifewatch Technologies , Ltd. | 2016-02-05 |
| ECG Mini System Continuous ECG Monitor and Arrhythmia Detector (K151269) | Lifewatch Technologies , Ltd. | 2016-01-15 |
| MoMe Software Platform (K152491) | Infobionic, Inc. | 2015-12-17 |
| MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM (K152550) | Medicalgorithmics S.A. | 2015-10-08 |
| BodyGuardian Remote Monitoring System (K151188) | Preventice | 2015-09-17 |
| CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector (K143359) | Lifewatch Technologies , Ltd. | 2015-09-11 |
| IntelliVue Patient Monitor (K151681) | Philips Medizin Systeme Boeblingen GmbH | 2015-07-17 |
| Medtronic Patient Asistant (K150117) | Medtronic, Inc. | 2015-05-27 |
| IntelliVue Patient Monitor (K150310) | Philips Medizin Systeme Boeblingen GmbH | 2015-05-13 |
| CardiacLinx (K142352) | Ross Medical Technology, Inc. | 2015-03-12 |
| MENNTOR X7 (K141441) | Mennen Medical , Ltd. | 2015-01-09 |
| VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) (K132407) | Lifewatch Technologies , Ltd. | 2014-12-19 |
| TELESENSE (K142180) | Scottcare Corporation | 2014-12-12 |
| CORCAM HEART MONITOR (K140548) | Corcam Technologia, SA | 2014-05-23 |
| V-PATCH SYSTEM (K131000) | Intelesens Limited | 2014-01-08 |
| MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM (K124060) | Medicalgorithmics S.A. | 2013-02-21 |
| BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT (K121197) | Preventice, Inc. | 2012-08-10 |
| MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM (K112921) | Medicalgorithmics S.A. | 2012-05-16 |
| ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT (K120774) | Welch Allyn, Inc. | 2012-04-10 |
| INTELLIVUE MX40 PATIENT MONITOR (K113125) | Philips Medical Systems | 2011-11-17 |
| INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) (K111160) | Intricon Datrix Corporation | 2011-08-01 |
| AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR (K102507) | Tz Medical, Inc. | 2011-06-13 |
| REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 (K103764) | Medtronic, Inc. | 2011-05-04 |
| CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (K110499) | Card Guard Scientific Survival , Ltd. | 2011-04-06 |
| SPACELABS MULTI-PARAMETER MODULE (K103142) | Spacelabs Healthcare, Inc. | 2011-03-03 |
| MEDICAL MAGNETIC TAPE RECORDER (K102111) | Wpr Medical AS | 2010-12-07 |
| MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 (K101703) | Card Guard Scientific Survival , Ltd. | 2010-07-13 |
| CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR (K101639) | Card Guard Scientific Survival , Ltd. | 2010-06-25 |
| VITALOGIK 6000/6500 (K093766) | Mennen Medical , Ltd. | 2010-05-07 |
| TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM (K100155) | Biomedical Systems Corp. | 2010-04-20 |
| TELESENTRY, MODEL TS01 (K092947) | Scottcare Corporation | 2010-02-26 |
| INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90 (K091927) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-11-03 |
| AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM (K091971) | Corventis, Inc. | 2009-08-27 |
| MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG (K090037) | Medicalgorithmics SP Z.O.O. | 2009-05-22 |
| EPICARDIA 5000 (K090834) | Medicomp, Inc. | 2009-05-15 |
| AVIVO MOBILE PATIENT MANAGEMENT SYSTEM (K083287) | Corventis, Inc. | 2009-02-03 |
| INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90 (K083517) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-01-16 |
| REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 (K082475) | Medtronic, Inc. | 2008-11-07 |
| INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 (K082633) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2008-10-03 |
| BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM (K081444) | Braemar, Inc. | 2008-07-31 |
| CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR (K081257) | Card Guard Scientific Survival , Ltd. | 2008-05-29 |
| DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE (K071889) | GE Healthcare | 2008-05-19 |
| CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (K071995) | Card Guard Scientific Survival , Ltd. | 2007-12-18 |
| REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539) (K071641) | Medtronic, Inc. | 2007-11-21 |
| VITALOGIK MODEL 4000/4500 (K073140) | Mennen Medical , Ltd. | 2007-11-21 |
| REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538 (K071655) | Medtronic, Inc. | 2007-11-21 |
| NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX (K071805) | Datascope Corp. | 2007-09-25 |
| MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER (K062976) | Ge Medical Systems Information Technologies | 2007-03-16 |
| STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0 (K070260) | Philips Medical Systems | 2007-02-23 |
| CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 (K053263) | Cardionet, Inc. | 2006-04-25 |
| VITALOGIK (K052288) | Mennen Medical , Ltd. | 2005-12-20 |
| ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.) (K052160) | Welch Allyn, Inc. | 2005-12-16 |
| LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P (K050919) | Analogic Corp. | 2005-06-14 |
| SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 (K050605) | Spacelabs Medical, Inc. | 2005-05-03 |
| SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 (K050175) | Spacelabs Medical, Inc. | 2005-03-04 |
| SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655 (K024213) | Siemens Medical Solutions USA, Inc. | 2004-03-23 |
| INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM (K033305) | Draeger Medical Systems, Inc. | 2003-10-31 |
| THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O. (K032858) | Philips Medizin Systeme Boblingen GmbH | 2003-10-10 |
| SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS (K031433) | Siemens Medical Solutions USA, Inc. | 2003-08-19 |
| CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION (K032370) | Ge Medical Systems Information Technologies | 2003-08-13 |
| MODIFICATION TO ENVOY PATIENT MONITOR (K023798) | Mennen Medical , Ltd. | 2002-12-03 |
| PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX (K020550) | Datascope Corp. | 2002-08-28 |
| COSMOS SYSTEM (K013046) | Spacelabs Medical, Inc. | 2002-08-21 |
| MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM (K022453) | Welch Allyn Protocol, Inc. | 2002-08-21 |
| DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE (K021376) | Datex-Ohmeda | 2002-07-24 |
| QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 (K021097) | Spacelabs Medical, Inc. | 2002-06-28 |
| MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B (K021300) | Philips Medical Systems | 2002-05-08 |
| ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I. (K021251) | Philips Medical Systems | 2002-05-07 |
| SOLAR 8000M SYSTEM (K012467) | General Electric Medical Systems Information Techn | 2002-02-11 |
| CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM (K002604) | Invivo Research, Inc. | 2002-02-07 |
| FUKUDA DENSHI DYNASCOPE MODEL DS-5700 (K020084) | Fukuda Denshi USA, Inc. | 2002-02-06 |
| CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001 (K012241) | Cardionet, Inc. | 2002-02-01 |
| PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR (K014159) | Philips Medical Systems, Inc. | 2002-01-18 |
| MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 (K012336) | Medical Data Electronics | 2001-10-03 |
| QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14 (K011339) | Spacelabs Burdick, Inc. | 2001-08-20 |
| SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER (K012461) | Siemens Medical Solutions USA, Inc. | 2001-08-17 |
| MODIFICATION TO ENVOY PATIENT MONITOR (K011784) | Mennen Medical , Ltd. | 2001-08-16 |
| AGILENT M2636B TELEMON B MONITOR (TELEMON B) (K011824) | Agilent Technologies, Inc. | 2001-07-02 |
| ENVOY PATIENT MONITOR (K001120) | Mennen Medical , Ltd. | 2001-05-08 |
| AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A (K002758) | Agilent Technologies Deutschland GmbH | 2001-02-22 |
| ORG-9200A (K002068) | Nihon Kohden America, Inc. | 2001-02-08 |
| Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 (K003576) | Quinton, Inc. | 2001-01-25 |
| SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION (K003246) | Siemens Medical Solutions USA, Inc. | 2000-12-21 |
| SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM (K003179) | Siemens Medical Solutions USA, Inc. | 2000-11-09 |