ClearanceBrief
Panels › Cardiovascular › Product code DXH · Class 2

Transmitters And Receivers, Electrocardiograph, Telephone

Regulation 870.2920

4510(k)s in 12 months (297 all time)
1recalls in 12 months (10 all time)
10recalls that name a 510(k)
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Top companies in DXH

Company510(k)sRecalls
Card Guard Scientific Survival , Ltd.280
Instromedix170
Medtronic Vascular150
AliveCor, Inc.100
Universal Medical, Inc.80
Survival Technology, Inc.70
Paceart, Inc.60
Aerotel, Ltd.50
Intermedics, Inc.50
Physio-Control Corp.50
Decided510(k)Device and applicantCode
Feb 13, 2026K250233PreemptiveAI Clinical SDK
Measure Labs, Inc. (Dba Preemptiveai, Inc.)
DXH
Dec 8, 2025K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software System
Heartbeam, Inc.
DXH
Dec 5, 2025K243438MEMO Patch M (MPT-E08R-UNC01)
Huinno Co., Ltd., KR
DXH
Nov 18, 2025K243981Hexoskin Medical System (7100-00016)
Carre Technologies, Inc., CA
DXH
Jun 17, 2025K243003VitalSigns 1-Lead Holter (VSH101)
VitalSigns Technology Co., Ltd., TW
DXH
Dec 6, 2023K233521QT ECG (QTERD100)
QT Medical, Inc.
DXH
Oct 20, 2022K222842V-Patch Cardiac Monitor
Shandong Corecare Technology Limited, CN
DXH
Sep 26, 2022K220795QT ECG
QT Medical, Inc.
DXH
Jul 19, 2022K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
Verily Life Sciences, LLC
DXH
May 25, 2022K220350KardiaMobile 6L
AliveCor, Inc.
DXH
Nov 30, 2021K211668KardiaMobile Card
AliveCor, Inc.
DXH
Sep 22, 2021K212160SimpleSENSE Platform
Nanowear, Inc.
DXH
Jun 30, 2021K210753KardiaMobile 6L
AliveCor, Inc.
DXH
Nov 6, 2020K201669SimpleSENSE
Nanowear, Inc.
DXH
Oct 30, 2020K193296eCordum Cardiac Monitor (eCordum CM)
Ecordum, Inc.
DXH
Sep 23, 2020K201208Halo AF Detection System
Livmor
DXH
Jan 24, 2020K191406KardiaMobile, KardiaStation
AliveCor, Inc.
DXH
Jan 17, 2020K192415Study Watch with Irregular Pulse Monitor
Verily Life Sciences, LLC
DXH
May 10, 2019K183319Triangle System
AliveCor, Inc.
DXH
Apr 12, 2019K182396KardiaMobile, KardiaStation
AliveCor, Inc.
DXH
Feb 22, 2019K181310HeartCheck Cardi Beat ECG Monitor with GEMS Mobile
Cardiocomm Solutions, Inc., CA
DXH
Feb 16, 2019K183704RX-1 Rhythm Express Remote Cardiac Monitoring System
VivaQuant, Inc.
DXH
Feb 8, 2019K182040Coala Heart Monitor
Coala Life AB, SE
DXH
Jan 17, 2019K182456Study Watch
Verily Life Sciences, LLC
DXH
Nov 30, 2018K173589Prizma
G-Medical Innovations , Ltd., IL
DXH
Sep 28, 2018K173872FibriCheck
Qompium NV, BE
DXH
Aug 11, 2018K173248CARDIOSKIN
Bioserenity Sas, FR
DXH
May 4, 2018K180157QT ECG
QT Medical, Inc.
DXH
Dec 15, 2017K172311BioFlux Device
Biotricity, Inc.
DXH
Nov 16, 2017K171816Kardia Band System
AliveCor, Inc.
DXH
Oct 18, 2017K172801ECG SENTINEL System
Cardiomedix, Inc.
DXH
Oct 2, 2017K170506ECG Check - Universal, ECG Check - Universal Plus
Cardiac Designs, Inc.
DXH
Sep 1, 2017K170181Prizma
G-Medical Innovations , Ltd., IL
DXH
Nov 30, 2016K161431SimplECG
Nanowear, Inc.
DXH
Apr 30, 2015K151013Vitaphone Tele ECG Loop Recorder
Vitasystems GmbH, DE
DXH
Mar 29, 2015K143032eMotion Faros ECG Mobile
Mega Electronics , Ltd., FI
DXH
Feb 17, 2015K142476Master Caution Device MCD
Healthwatch , Ltd., IL
DXH
Jan 27, 2015K142743AliveCor Heart Monitor
AliveCor, Inc.
DXH
Dec 3, 2014K142672AliveCor Heart Monitor
AliveCor, Inc.
DXH
Aug 18, 2014K133703PHYSIOGLOVE ET SYSTEM
Commwell R&D , Ltd.
DXH
Aug 15, 2014K140933ALIVECOR HEART MONITOR
AliveCor, Inc.
DXH
Aug 5, 2014K141813RHYTHMSTAR SYSTEM
RhythMedix, LLC
DXH
Apr 4, 2014K130878CLOUDEKG
Makromed, Inc.
DXH
Mar 19, 2014K132206MELYS ATRIAL FIBRILLATION SCREENING MONITOR
Advanced Fluidics, LLC
DXH
Nov 26, 2013K131699EMOTION ECG MOBILE
Mega Electronics , Ltd., NL
DXH
Jun 25, 2013K121628EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)
Epi Mobile Health Solutions (S) Pte, Ltd.
DXH
Feb 14, 2013K122184ECG CHECK
Cardiac Designs, LLC
DXH
Feb 22, 2012K113514SMARTHEART
Shl Telemedicine International , Ltd., IL
DXH
Apr 20, 2010K100383VITAPHONE. MODEL 100 BT
Vitasystems GmbH, DE
DXH
Mar 25, 2010K093976RAISIN PERSONAL MONITOR
Proteus Biomedical, Inc.
DXH

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