Medical Devices

Examples of MMAs the FDA Has Cleared or Approved

Following are some examples of mobile medical applications  the FDA has cleared since 1997.  The list is intended to show examples of mobile medical apps and does not include all the mobile medical apps we have cleared.  For more information about any of the apps below, please search the FDA 510(k) medical devices database by 510(k) number in the search field.

FDA Cleared Mobile Medical Applications
Last updated (February 17, 2015)

Device NameApplicant510(k) NumberDecision Date
AIDERA DIASEND SYSTEMAIDERA ABK10180612/7/2010
AIRSTRIP OBMP4 SOLUTIONS, LPK04208201/21/2005
AIRSTRIP OBAIRSTRIP TECHNOLOGIES, LPK09006101/23/2009
AIRSTRIP OBAIRSTRIP TECHNOLOGIES, LPK09026902/13/2009
AIRSTRIP REMOTE PATIENT MONITORINGAIRSTRIP TECHNOLOGIES, LPK13345002/14/2014
AIRSTRIP REMOTE PATIENT MONITORING (RPM)AIRSTRIP TECHNOLOGIES, LPK11050303/10/2011
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGAIRSTRIP TECHNOLOGIES, LPK11223508/26/2011
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGAIRSTRIP TECHNOLOGIES, LPK12187107/3/2012
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1AIRSTRIP TECHNOLOGIES, LPK10013307/23/2010
ALIVECOR HEART MONITORALIVECOR INC.K14093308/15/2014
AliveCor Heart MonitorALIVECOR INC.K14267212/03/2014
ALIVECOR HEART MONITOR FOR IPHONEALIVECOR, INC.K12235611/19/2012
ALIVECOR HEART MONITOR OTCALIVECOR INC.K13092102/06/2014
ASTHMAPOLIS SYSTEMRECIPROCAL LABS CORPORATIONK12160907/2/2012
AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZBAVITA CORPORATIONK07213712/7/2007
AYCAN MOBILEAYCAN DIGITALSYSTEME GMBHK12226009/12/2012
BEAM BRUSH/BEAM APPBEAM TECHNOLOGIES, LLCK12116506/21/2012
BECTON DICKINSON INTELLIPORT SYSTEMBECTON, DICKINSON AND COMPANYK14147412/18/2014
BIOHARNESSZEPHYR TECHNOLOGY CORPORATIONK11304508/14/2012
BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECTPREVENTICE, INC.K12119708/10/2012
CARESTREAM PACSCARESTREAM HEALTH, INC.K11091910/20/2011
CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATIONCARESTREAM HEALTH INC.K13282402/06/2014
CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTORCARD GUARD SCIENTIFIC SURVIVAL LTD.K11049904/6/2011
CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTORCARD GUARD SCIENTIFIC SURVIVAL, LTD.K08125705/29/2008
CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTORCARD GUARD SCIENTIFIC SURVIVAL, LTD.K10163906/25/2010
CG-6108 ARRHYTHMIA ECG EVENT RECORDERCARD GUARD SCIENTIFIC SURVIVAL, LTD.K06091108/22/2006
CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTORCARD GUARD SCIENTIFIC SURVIVAL, LTD.K07199512/18/2007
CONFIDANT 2.5CONFIDANT INC.K07269811/16/2007
CUSTOMIZED SOUND THERAPY (CST)TINNITUS OTOSOUND PRODUCTS, LLCK07059907/13/2007
DANAANTHROTRONIX, INC.K14186510/15/2014
DASH KNEEBRAINLAB AGK10225105/17/2011
DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWAREGE HEALTHCAREK05297501/20/2006
DCAS IGP&P CO.K14086907/03/2014
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1WELLDOC, INCK10006607/15/2010
EBM IDO VIEWEREBM TECHNOLOGIES, INC.K14039909/18/2014
ECARE COORDINATOR (ECC)VISICU, INC.K14170609/09/2014
FAMILY HEALTHWARE K13217305/30/2014
FORA CARE BLOOD PRESSURE MONITORING SYSTEMFOR A CARE INC.K13358804/25/2014
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEMABBOTT DIABETES CARE INC.K02086606/11/2002
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEMABBOTT DIABETES CARE INC.K02086606/11/2002
FRONTIER/ FRONTIER II /ANTHEM FAMILY OF CRT-P'SST. JUDE MEDICALP030035/S09804/10/2014
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931ANDON HEALTH CO.,LTDK10293902/23/2011
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITORANDON HEALTH CO., LTDK12147006/14/2012
GENESIS TOUCH SYSTEMHONEYWELL HOMMEDK14179211/25/2014
GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025INFOPIA CO., LTDK09116805/27/2010
HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLEH2 INC.K14186212/02/2014
HEALTHINTERLINK BEACONHEALTHINTERLINK, LLCK13325203/14/2014
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV DAGAMATRIX INCK10354412/7/2011
IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEMIDEAL LIFE INC.K13218006/25/2014
IEVA REHABILITATIVE POSITIONAL DEVICEREMENDIUM LABS, LLCK13399010/09/2014
IGLUCOSE SYSTEMPOSITIVEID CORPORATIONK11193211/10/2011
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEMANDON HEALTH CO., LTD.K13379005/22/2014
IMCO-STATIMCO TECHNOLOGIESK06339212/12/2006
IMPAX VOLUME VIEWING 3.0AGFA HEALTHCARE NVK13313503/07/2014
INTUITIONTERARECON, INC.K12191604/2/2013
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITORANDON HEALTH CO.,LTDK12067206/1/2012
MCKESSON CARDIOLOGY ECG MOBILEMCKESSON ISRAEL LTDK13353404/18/2014
MCKESSON RADIOLOGYMCKESSON MEDICAL IMAGING COMPANYK14090907/02/2014
MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100MEDAPPS, INC.K06237707/3/2007
MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECGMEDICALGORITHMICS SP Z.O.O.K09003705/22/2009
MOBILE MIMMIM SOFTWARE INC.K10378502/4/2011
MOBILE MIMMIM SOFTWARE INC.K11293012/2/2011
MOBILECT VIEWERNEPHOSITY, INC.K12308205/16/2013
MOBILE-PATIENT VIEWERDATA CRITICAL CORPORATIONK01143607/5/2001
MOBILE-PATIENT VIEWERDATA CRITICAL CORPORATIONK01143607/5/2001
MOBIUS ULTRASOUND IMAGING SYSTEMMOBISANTE, INC.K10215301/20/2011
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084CARD GUARD SCIENTIFIC SURVIVAL, LTD.K10170307/13/2010
MODIFICATION TO: POCKETVIEW ECG SOFTWAREMICROMEDICAL INDUSTRIES, LTD.K01331101/3/2002
MODIFICATION TO: POCKETVIEW ECG SOFTWAREMICROMEDICAL INDUSTRIES, LTD.K01331101/3/2002
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTORINFOBIONIC, INC.K13375309/19/2014
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMSENTRA HEALTH SYSTEMS, LTD.K08170301/8/2009
MYHEALTHPOINT TELEHEALTH MANAGERENTRA HEALTH SYSTEMSK13293004/14/2014
MYVISIONTRACK(TM)VITAL ART AND SCIENCE INCORPORATEDK12173802/22/2013
NUVIS DIAGNOSTIC ULTRASOUND SYSTEMPHILIPS HEALTHCARE INC.K13383301/17/2014
ORTHOSIZEORTHOSIZE LLCK12011503/14/2012
OSTOM-I ALERT11 HEALTH AND TECHNOLOGIES LLCK14093810/10/2014
PANOPTICWELCH ALLYN, INC.K12140512/20/2012
PHYSIOGLOVE ET SYSTEMCOMMWELL LTD.K13370308/18/2014
PILL PHONEVOCELK06029803/29/2006
PIXEL APPGAUSS SURGICAL, INC.K12047304/9/2012
PIXEL APPGAUSS SURGICAL, INC.K12127406/27/2012
PROPELLER SYSTEM - MODEL 2RECIPROCAL LABS CORPORATIONK14063805/02/2014
PROTEUS INGESTION CONFINMATION SYSTEMSPROTEUS BIOMEDICAL, INC.K11307005/1/2012
QARDIOARMQARDIO, INCK14006706/18/2014
RAPIDRESULTSRAMSOFT, INC.K14188110/31/2014
REKA E100REKA PTE LTDK11143809/12/2011
RESOLUTIONMD MOBILECALGARY SCIENTIFIC INC.K13350803/26/2014
RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31CALGARY SCIENTIFIC, INC.K12318603/14/2013
RESOLUTIONMD MOBILE MODEL RMB-MOB-2XCALGARY SCIENTIFIC, INC.K11134609/9/2011
RHYTHMSTAT XLDATA CRITICAL CORP.K97165012/4/1997
SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDERNORTHEAST MONITORING, INC.K04190108/31/2004
SILHOUETTE, MODEL 1000.01ARANZ MEDICAL LIMITEDK07042606/29/2007
SMARTHEARTSHL TELEMEDICINE INTERNATIONAL LTD.K11351402/22/2012
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSMITH & NEPHEW, INC.K14252011/20/2014
SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARYSIGMA INTL.K04212108/26/2004
SURGICASE CONNECTMATERIALISE N.V.K11359904/27/2012
SYMCARE DIABETES MANAGEMENT PROGRAMSYMCARE PERSONALIZED HEALTH SOLUTIONS, INCK08326303/13/2009
Synapse 3D Liver and Kidney AnalysisFUJIFILM MEDICAL SYSTEMS U.S.A., INC.K14252112/01/2014
SYNGO.VIA WEB VIEWERSIEMENS AG, MEDICAL SOLUTIONSK13099801/03/2014
TABLET VIEWER SOFTWARE FOR IMAGE SUITECARESTREAM HEALTH INC.K14027104/01/2014
TM2005 PERSONAL MEDICAL PHONE CENTERCARD GUARD SCIENTIFIC SURVIVAL, LTD.K02436501/15/2003
VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221WEISSBURG ASSOCIATESK05185709/15/2005
VESTIBULAR ANALYSIS APPARATUSCAPACITY SPORTS, LLCK12159009/20/2012
VITAL SIGNS PATCH SYSTEM (IN SHORT "VSP")LIFEWATCH TECHNOLOGIES LTD.K13240712/19/2014
WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4AGAMATRIXK10159710/18/2010
WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWAREGE HEALTHCAREK06199408/11/2006
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEMWELLDOC, INCK11237010/14/2011
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEMWELLDOC, INCK12031402/24/2012
WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTEWELLDOC INC.K14127307/08/2014
WITHINGS BLOOD PRESSURE MONITORWITHINGSK11087205/20/2011
WITHINGS BLOOD PRESURE MONITORWITHINGSK13312503/24/2014
WITHINGS, SMART BODY SCALEZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.K12197109/27/2012
Z1 CPAP SYSTEMHUMAN DESIGN MEDICAL, LLCK14092910/17/2014
ZEMPROZEMPROK13237003/26/2014
ZOLL CODE WRITERZOLL MEDICAL CORPORATIONK13248804/03/2014
ZOLL X SERIESZOLL MEDICAL CORPORATIONK14177411/19/2014

 

Page Last Updated: 02/18/2015
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