| ENSITE VELOCITY SYSTEM (K130594) | St Jude Medical | 2013-05-03 |
| MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS (K130626) | Ge Medical Systems Information Technologies, Inc. | 2013-05-01 |
| RHYTHM VIEW (K123295) | Topera, Inc. | 2013-04-24 |
| QUANTIEN MEASUREMENT SYSTEM (K123984) | Radi Medical Systems AB | 2013-03-28 |
| MUSE CARDIOLOGY INFORMATION SYSTEM (K130155) | Ge Medical Systems Information Technologies, Inc. | 2013-03-01 |
| HEALTHVIEW ECG MANAGER (K123466) | Lumedx | 2012-12-20 |
| ST80I STRESS TEST SYSTEM (K121638) | Philips Health Care | 2012-07-18 |
| INTELLISPACE ECG (K120855) | Philips Health Care | 2012-06-29 |
| CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) (K120550) | Biosense Webster, Inc. | 2012-05-07 |
| V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM (K113811) | C.R. Bard Inc., Bard Electrophysiology Division | 2012-03-16 |
| HORIZON CARDIOLOGY ECG MANAGEMENT (K113515) | Mckesson Israel , Ltd. | 2012-03-16 |
| MEDIGUIDE TECHNOLOGY (K120301) | St. Jude Medical, Mediguide Navigation Systems | 2012-02-24 |
| ENSITE VELOCITY SYSTEM V.3.0 (K112688) | St Jude Medical | 2011-11-09 |
| MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM (K111200) | GE Healthcare | 2011-10-12 |
| CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 (K112007) | Biosense Webster, Inc. | 2011-10-05 |
| RHYTHMVIEW (TM) (K110878) | Topera, Inc. | 2011-09-23 |
| SPACELABS PATHFINDER SL HOLTER ANALYZER (K110001) | Spacelabs Healthcare, Ltd. | 2011-06-14 |
| MUSE CARDIOLOGY INFORMATION SYSTEM (K110132) | Ge Medical Systems Information Technologies, Inc. | 2011-05-25 |
| 4D LV-ANALYSIS 3.0 (K110746) | Tomtec Imaging Systems GmbH | 2011-05-24 |
| ENSITE VELOCITY SYSTEM (K110549) | St Jude Medical | 2011-05-05 |
| SPACELABS SMART DISCLOSURE SYSTEM (K110779) | Spacelabs Healthcare | 2011-04-19 |
| CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM (K103678) | Ge Medical Systems Information Technologies GmbH | 2011-02-16 |
| 4D MV-ASSESSMENT 2.0 (K103782) | Tomtec Imaging Systems GmbH | 2011-01-27 |
| CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) (K103746) | Biosense Webster, Inc. | 2011-01-21 |
| GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II) (K102905) | Mediguide, Ltd. | 2010-10-29 |
| LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE (K101331) | C.R. Bard Inc., Bard Electrophysiology Division | 2010-10-08 |
| ENSITE VELOCITY SYSTEM (K101328) | St Jude Medical | 2010-07-14 |
| ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) (K101667) | St Jude Medical | 2010-07-02 |
| CARTO XP EP NAVIGATION SYSTEM, VERSION 10 (K093566) | Biosense Webster, Inc. | 2010-06-18 |
| ENSITE VELOCITY SYSTEM, MODEL EE3000 (K101419) | St Jude Medical | 2010-06-11 |
| CAMBRIDGE HEART OEM (K100362) | Cambridge Heart, Inc. | 2010-04-14 |
| ENSITE VELOCITY SYSTEM V1.3 (K093942) | St Jude Medical | 2010-02-25 |
| ODYSSEY WORKSTATION (K093092) | Stereotaxis, Inc. | 2010-01-21 |
| MARS HOLTER ANALYSIS WORKSTATION (K093141) | Ge Medical Systems Information Technologies | 2009-12-29 |
| EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE (K093583) | St Jude Medical | 2009-12-15 |
| CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES (K093455) | Biosense Webster, Inc. | 2009-12-04 |
| GUIDED MEDICAL POSITIONING SYSTEM (GMPS) (K091781) | Mediguide, Ltd. | 2009-10-16 |
| CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES (K090017) | Biosense Webster, Inc. | 2009-10-13 |
| RADIANALYZER XPRESS (K092105) | Radi Medical Systems AB | 2009-10-09 |
| EP-WORKMATE SYSTEM, VERSION 4.2 (K092810) | St Jude Medical | 2009-10-09 |
| CARTO RMT EP NAVIGATION SYSTEM V8 (K091789) | Biosense Webster, Inc. | 2009-10-01 |
| HORIZON XVU (K091165) | Mennen Medical , Ltd. | 2009-08-07 |
| ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM (K091075) | iRhythm Technologies, Inc. | 2009-07-21 |
| ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010 (K083328) | St Jude Medical | 2009-05-22 |
| MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE (K083639) | Ge Medical Systems Information Technologies | 2009-02-17 |
| HEARTSUITE HEMODYNAMICS 7.10 (K082421) | Emageon, Inc. | 2008-12-17 |
| BP LIMBO XL, BPTANGO XL, BP SALSA XL (K072752) | Datadancer Medical Systems | 2008-10-31 |
| ENSITE FUSION DYNAMIC REGISTRATION TOOL (K082467) | St Jude Medical | 2008-09-11 |
| HORIZON XVU (K081484) | Mennen Medical , Ltd. | 2008-06-20 |
| ENSITE FUSION DYNAMIC REGISTRATION TOOL (K071818) | St Jude Medical | 2007-12-20 |
| CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) (K072202) | Biosense Webster, Inc. | 2007-11-19 |
| MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM (K072502) | Ge Medical Systems Information Technologies | 2007-11-19 |
| VENDYS, MODEL 6000 B B/C (K072919) | Endothelix, Inc. | 2007-11-02 |
| EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM (K071348) | Mennen Medical , Ltd. | 2007-09-07 |
| CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR (K071911) | Innovision A/S | 2007-09-07 |
| VENDYS MODEL 5000 B/BC (K060980) | Endothelix, Inc. | 2007-08-16 |
| CARTO XP EP NAVIGATION SYSTEM, VERSION 9 (K070240) | Biosense Webster, Inc. | 2007-05-04 |
| MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000 (K070902) | St Jude Medical | 2007-05-01 |
| HORIZON SE (K070254) | Mennen Medical , Ltd. | 2007-04-19 |
| EP-WORKMATE (K070706) | Ep Medsystems | 2007-04-11 |
| SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 (K063490) | Spacelabs Medical, Inc. | 2007-03-15 |
| CARDIODAY, VERSION 2.0 (K070280) | Getemed Medizin- Und Informationstechnik AG | 2007-02-23 |
| MAPMATE (K063277) | Ep Medsystems, Inc. | 2006-11-30 |
| HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0 (K061905) | Medcon , Ltd. | 2006-11-08 |
| EP-WORKMATE (K063113) | Ep Medsystems | 2006-10-27 |
| MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM (K061741) | GE Healthcare | 2006-09-15 |
| MODIFICATION TO ENSITE SYSTEM, MODEL EE3000 (K060954) | St. Jude Medical, Inc.-Endocardial Solutions | 2006-04-21 |
| NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE (K053194) | Biosense Webster, Inc. | 2006-03-09 |
| INNOCOR (K051907) | Innovision A/S | 2006-03-02 |
| DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES (K052976) | GE Healthcare | 2006-01-13 |
| MEDILOG DARWIN HOLTER ANALYSIS (K053369) | Huntleigh Healthcare | 2005-12-22 |
| DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES (K052977) | GE Healthcare | 2005-11-22 |
| CARDIOSERVER (K052883) | Datrix | 2005-11-01 |
| CARTO RMT EP NAVIGATION SYSTEM (K042681) | Biosense Webster, Inc. | 2005-09-29 |
| MARS HOLTER ANALYSIS WORKSTATION (K051026) | Ge Medical Systems Information Technologies | 2005-07-19 |
| CARDIODAY (K051471) | Getemed Medizin- Und Informationstechnik AG | 2005-06-29 |
| MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM (K050093) | Ge Medical Systems Information Technologies | 2005-05-13 |
| WINDSURFER (K050561) | Medcon , Ltd. | 2005-05-04 |
| LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE (K043604) | Vivometrics, Inc. | 2005-04-29 |
| HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM (K050225) | Cambridge Heart, Inc. | 2005-04-07 |
| MUSE CARDIOLOGY INFORMATION SYSTEM (K050614) | Ge Medical Systems Information Technologies | 2005-04-05 |
| CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8 (K042999) | Biosense Webster, Inc. | 2005-03-21 |
| HORIZON ANGIO CATHLAB (K043564) | Mennen Medical , Ltd. | 2005-01-27 |
| CARDIOSTATION-100 (CS-100) (K041031) | Us Clover Co. | 2005-01-26 |
| MODIFICATION TO: RADIANALYZER, MODEL 12711 (K042628) | Radi Medical Systems AB | 2005-01-19 |
| CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD) (K042849) | Cardiobiomedical Corporation | 2005-01-13 |
| VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS (K033266) | Medical Imaging Applications, LLC | 2004-12-16 |
| HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES (K042148) | Ge Medical Syst. Information Technologies | 2004-12-03 |
| QRS-CARD CARDIOLOGY SUITE (K042799) | Pulse Biomedical, Inc. | 2004-10-22 |
| SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER (K042002) | Ela Medical, Inc. | 2004-10-20 |
| ENSITE SYSTEM, MODEL EE3000 (K042493) | Endocardial Solutions, Inc. | 2004-10-15 |
| HOLTER PLUS (K042463) | Rozinn Electronics, Inc. | 2004-09-22 |
| ENDO PAT 2000 (K032519) | Itamar Medical | 2003-11-12 |
| ENSITE SYSTEM (K033211) | Endocardial Solutions, Inc. | 2003-10-30 |
| T-WAVE ALTERNANS (TWA) ALGORITHM OPTION (K032513) | Ge Medical Systems Information Technologies | 2003-10-30 |
| MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM (K032577) | Ge Medical Systems Information Technologies | 2003-10-10 |
| GALIX WINTER (K030145) | Galix Biomedical Instrumentation, Inc. | 2003-09-17 |
| INFINITY MEGACARE (K031970) | Siemens Medical Solutions USA, Inc. | 2003-09-09 |
| PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 (K032038) | Quinton, Inc. | 2003-09-05 |
| EP-WORKMATE WITH RPM SYSTEM (K032225) | Ep Medsystems | 2003-08-20 |