| GuardianTM Burr Hole Cover System (K181382) | St Jude Medical | 2018-07-20 |
| EnSite Velocity Cardiac Mapping System v5.2 (K172396) | St Jude Medical | 2018-04-23 |
| myMerlin(TM) Mobile Application Model APP1001 (K173232) | St Jude Medical | 2017-11-02 |
| Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D (K160335) | St Jude Medical | 2016-12-13 |
| MediGuide Technology System (K162643) | St Jude Medical | 2016-12-13 |
| AutoMark Module (K160218) | St Jude Medical | 2016-12-13 |
| EnSite Precision Cardiac Mapping System v2.0 (K160210) | St Jude Medical | 2016-12-13 |
| Pacel Flow Directed Pacing Catheter (K161873) | St Jude Medical | 2016-11-22 |
| Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 (K160187) | St Jude Medical | 2016-10-21 |
| EnSite Velocity Surface Electrode Kit (K160186) | St Jude Medical | 2016-10-07 |
| Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover (K152342) | St Jude Medical | 2016-06-09 |
| Pacel Bipolar Pacing Catheters (K152784) | St Jude Medical | 2015-10-22 |
| WorkMate Claris System, WorkMate Claris System Display Plus (K151911) | St Jude Medical | 2015-10-22 |
| St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter (K151622) | St Jude Medical | 2015-07-15 |
| St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter (K150631) | St Jude Medical | 2015-04-01 |
| CPS Direct MediGuide Enabled outer catheter (K142239) | St Jude Medical | 2014-12-18 |
| CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter (K142235) | St Jude Medical | 2014-12-18 |
| CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector (K142254) | St Jude Medical | 2014-11-13 |
| ENSITE VELOCITY SYSTEM (K141050) | St Jude Medical | 2014-06-06 |
| SWIFT-LOCK ANCHOR (K140272) | St Jude Medical | 2014-05-02 |
| ULTIMUM EV HEMOSTASIS INTRODUCER (K140327) | St Jude Medical | 2014-03-11 |
| EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE (K132073) | St Jude Medical | 2013-09-09 |
| ENSITE VELOCITY SYSTEM (K130727) | St Jude Medical | 2013-08-29 |
| AMPLATZER TORQ VUE LP DELIVERY SYSTEM (K131063) | St Jude Medical | 2013-08-15 |
| MULTI LEAD TRIAL CABLE (K130545) | St Jude Medical | 2013-06-18 |
| ENSITE VELOCITY SYSTEM (K130594) | St Jude Medical | 2013-05-03 |
| CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER (K130257) | St Jude Medical | 2013-03-20 |
| CPS AIM UNIVERSAL SLITTABLE INNER CATHETER (K130252) | St Jude Medical | 2013-03-20 |
| BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 (K122587) | St Jude Medical | 2013-02-07 |
| SJM CONFIRM (K122161) | St Jude Medical | 2012-11-28 |
| VIEWFLEX XTRA ICE CATHETER (K121381) | St Jude Medical | 2012-06-07 |
| ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER (K121006) | St Jude Medical | 2012-05-03 |
| RAPID PROGRAMMER (K113611) | St Jude Medical | 2012-04-20 |
| RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN (K120544) | St Jude Medical | 2012-03-19 |
| PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER (K113584) | St Jude Medical | 2012-03-02 |
| ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL (K113773) | St Jude Medical | 2012-01-18 |
| ENSITE VELOCITY SYSTEM V.3.0 (K112688) | St Jude Medical | 2011-11-09 |
| EPIDUCER LEAD DELIVERY SYSTEM (K110609) | St Jude Medical | 2011-06-24 |
| ENGAGE/ENGAGE TR INTRODUCERS (K111092) | St Jude Medical | 2011-06-09 |
| AGILIS NXT STEERABLE INTRODUCER (K110450) | St Jude Medical | 2011-05-10 |
| ENSITE VELOCITY SYSTEM (K110549) | St Jude Medical | 2011-05-05 |
| AGILIS ES STEERABLE INTRODUCER (K103083) | St Jude Medical | 2011-04-08 |
| VANTAGE VIEW SYSTEM (K110085) | St Jude Medical | 2011-01-26 |
| LIVEWIRE ELECTOPHYSIOLOGY CATHETER (K102721) | St Jude Medical | 2010-10-18 |
| ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 (K101955) | St Jude Medical | 2010-10-15 |
| ENSITE VERISMO SEGMENTATION TOOL V.2.0 (K101697) | St Jude Medical | 2010-09-22 |
| SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A (K101968) | St Jude Medical | 2010-09-15 |
| 6F ENGAGE/ENGAGE TR INTRODUCER (K101883) | St Jude Medical | 2010-09-07 |
| INQUIRY AFOCUSII DIAGNOSTIC CATHETER (K101623) | St Jude Medical | 2010-08-13 |
| 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 |
| ENSITE VELOCITY SYSTEM, MODEL EE3000 (K101419) | St Jude Medical | 2010-06-11 |
| VIEWFLEX PLUS ICE CATHETER (K101239) | St Jude Medical | 2010-06-02 |
| ROLL-X GUIDEWIRE (K100710) | St Jude Medical | 2010-04-28 |
| ENSITE VELOCITY SYSTEM V1.3 (K093942) | St Jude Medical | 2010-02-25 |
| EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE (K093583) | St Jude Medical | 2009-12-15 |
| ENGAGE TR INTRODUCER (K093130) | St Jude Medical | 2009-11-04 |
| SJM ATTUNE ANNULOPLASTY RING (K092876) | St Jude Medical | 2009-10-16 |
| EP-WORKMATE SYSTEM, VERSION 4.2 (K092810) | St Jude Medical | 2009-10-09 |
| ENGAGE/ENGAGE TR (K092575) | St Jude Medical | 2009-10-08 |
| SEGUIN ANNULOPLASTY RING (K092310) | St Jude Medical | 2009-08-27 |
| ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010 (K083328) | St Jude Medical | 2009-05-22 |
| ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM (K081803) | St Jude Medical | 2009-05-13 |
| ULTIMUM/ENGAGE/ENGAGE TR (K091137) | St Jude Medical | 2009-04-22 |
| STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 (K090163) | St Jude Medical | 2009-04-01 |
| ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR (K083835) | St Jude Medical | 2009-01-23 |
| REFLEXION HD HIGH-DENSITY MAPPING CATHETER (K080179) | St Jude Medical | 2009-01-07 |
| AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323 (K083402) | St Jude Medical | 2008-12-15 |
| CPS AIM SL SLITTABLE INNER CATHETER (K082932) | St Jude Medical | 2008-12-12 |
| AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 (K081645) | St Jude Medical | 2008-12-09 |
| AGILIS NXT STEERABLE INTRODUCER (K083083) | St Jude Medical | 2008-11-06 |
| EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2 (K082279) | St Jude Medical | 2008-09-16 |
| ENSITE FUSION DYNAMIC REGISTRATION TOOL (K082467) | St Jude Medical | 2008-09-11 |
| ROLL-X GUIDEWIRE (K082304) | St Jude Medical | 2008-08-27 |
| SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR (K081365) | St Jude Medical | 2008-08-15 |
| EPICOR ABLATION SYSTEM (K080292) | St Jude Medical | 2008-07-25 |
| MODIFICATION TO PROXIS SYSTEM (K073563) | St Jude Medical | 2008-01-31 |
| ENSITE FUSION DYNAMIC REGISTRATION TOOL (K071818) | St Jude Medical | 2007-12-20 |
| BRK TRANSSEPTAL NEEDLE (K072278) | St Jude Medical | 2007-09-13 |
| REFLEXION SPIRAL VARIABLE RADIUS CATHETER (K072012) | St Jude Medical | 2007-08-22 |
| ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 (K070417) | St Jude Medical | 2007-06-05 |
| MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 (K063638) | St Jude Medical | 2007-05-11 |
| MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000 (K070902) | St Jude Medical | 2007-05-01 |
| STRADA CAROTID GUIDING SHEATH (K070166) | St Jude Medical | 2007-04-06 |
| REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804 (K062251) | St Jude Medical | 2006-10-20 |
| PROXIS SYSTEM, MODEL EPS101 (K060651) | St Jude Medical | 2006-09-13 |
| FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER (K061015) | St Jude Medical | 2006-08-03 |
| VENTURE WIRE CONTROL CATHETER, MODEL WCC (K061843) | St Jude Medical | 2006-08-01 |
| CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS (K061710) | St Jude Medical | 2006-07-14 |
| AGILIS NXT STEERABLE INTRODUCER (K061363) | St Jude Medical | 2006-07-12 |
| CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148 (K053217) | St Jude Medical | 2006-03-08 |
| CPS DIRECT SL OUTER CATHETER (K053277) | St Jude Medical | 2006-02-24 |
| LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN (K052575) | St Jude Medical | 2006-01-19 |
| SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER (K052644) | St Jude Medical | 2005-12-05 |
| ENSITE VERISMO SOFTWARE (K051840) | St Jude Medical | 2005-08-15 |
| REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805 (K040165) | St Jude Medical | 2004-05-12 |
| APEEL CS CATHETER DELIVERY SYSTEM (K031906) | St Jude Medical | 2003-07-18 |
| MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) (K023447) | St Jude Medical | 2002-10-31 |
| LIVESIRE ELECTROPHYSIOLOGY CATHETER (K022380) | St Jude Medical | 2002-10-01 |
| SPYGLASS 4 FR ANGIOGRAPHICY CATHETER (K020890) | St Jude Medical | 2002-04-17 |