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Cardiovascular

28,927 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM, ARCTIC FRONT ADVANCE CARDUAC CRYIABKATUIB CATHETER, CRYOCONSOLE AND ACCESSORIE (P100010/S032)Medtronic Cryocath, LP2013-12-18
BLAZER II, BLAZER II HTD,BLAZER PRIME HTD (P920047/S064)Boston Scientific Corp2013-12-18
WALLSTENT TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S051)Boston Scientific Corp2013-12-18
EPIC VACULAR SELF EXPANDING STENT SYSTEM (P110035/S024)Boston Scientific Corp2013-12-18
WALLSTENT LILAC ENDOPROSTHESIS (P940019/S043)Boston Scientific Scimed, Inc.2013-12-18
EXPRESS2 MONORAIL AND OTW CORONARY STENT SYSTEM (P020009/S113)Boston Scientific Scimed, Inc.2013-12-18
THERAPY COOL FLEX ABLATION CATHETER (P110016/S008)ABBOTT MEDICAL2013-12-18
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S064)Boston Scientific Corp2013-12-18
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S119)Boston Scientific Scimed, Inc.2013-12-18
BLAZER II XP,BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS (P020025/S051)Boston Scientific2013-12-18
THORATEC VENTRICULAR ASSIST DEVICE(VAD) (P870072/S057)Thoratec Laboratories Corp.2013-12-18
ATTTAIN ABILITY (P080006/S062)Medtronic, Inc.2013-12-18
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S052)Boston Scientific Corp2013-12-18
BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D IPG (P010031/S407)Medtronic Cardiac Rhythm Disease Management2013-12-17
ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S355)Medtronic, Inc.2013-12-17
PUNCTUA CRT-DS, COGNIS CRT-DS, ENERGEN CRT-D'S, INCEPTA CRT-DS (P010012/S344)Boston Scientific Corp2013-12-17
ELLIPSE FAMILY OF ICDS (P910023/S321)ABBOTT MEDICAL2013-12-17
BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S412)Medtronic Cardiac Rhythm Disease Management2013-12-17
EVERA S DR ICD, EVERA VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S450)Medtronic Cardiac Rhythm Disease Management2013-12-17
BRAVA C RT-D; VIVA S CRT-D; VIVA XT CRT-D (P010031/S410)Medtronic Cardiac Rhythm Disease Management2013-12-17
EVERA S DR ICD; EVERA S VR ICD; EVERA XT DR ICD; EVERA XT VR ICD (P980016/S448)Medtronic Cardiac Rhythm Disease Management2013-12-17
PUNTUA ICD'S, TELIGEN ICD'S, ENERGEN ICD'S AND INCEPTA ICD'S (P960040/S308)Boston Scientific2013-12-17
CURRENT,CURRENT ACCEL,CURRENT +,ELLIPSE,FORTIFY,FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S324)ABBOTT MEDICAL2013-12-17
PROMOTE, PROMOTE ACCEL,PROMOTE Q, PROMOTE QUADRA,PROMOTE+,QUADRA ASSURA,UNIFY,UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S255)ABBOTT MEDICAL2013-12-17
BRAVA CRT-D, VIVA S CRT-DAND VIVA XT- CRT-D (P010031/S408)Medtronic Cardiac Rhythm Disease Management2013-12-16
EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD (P980016/S446)Medtronic Cardiac Rhythm Disease Management2013-12-16
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S023)Boston Scientific Corporation2013-12-16
ATTAIN ABILITY LEAD (P080006/S061)Medtronic, Inc.2013-12-16
SPRINT QUANTTRO LEAD (P920015/S124)Medtronic, Inc.2013-12-16
SELECTSURE LEAD (P030036/S067)Medtronic Cardiac Rhythm Disease Management2013-12-16
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S084)Medtronic, Inc.2013-12-15
INTEGRITY RAPID EXCHANGE CORONARY STENT SYSTEMS (P030009/S071)Medtronic, Ireland2013-12-15
RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S030)Medtronic Vascular2013-12-15
ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER (P900056/S129)Boston Scientific Corp2013-12-15
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S022)Syncardia Systems, LLC2013-12-13
TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S007)Endologix, LLC2013-12-13
SUBCUTANEOUS LEAD,TRANSVENE CS/SVC LEAD (P920015/S125)Medtronic, Inc.2013-12-12
ENDURANT STENT GRAFT SYSTEM (P100021/S030)Medtronic Vascular2013-12-12
CAPSURE LEAD (P890003/S293)Medtronic, Inc.2013-12-12
ASSURANT COBALT (P110011/S005)Medtronic, Ireland2013-12-12
ARCTIC FRONT CRYOABLATION CATHETER, ARCTIC FRONT ADVANCE CRYOABLATION CATHETER (P100010/S025)Medtronic Cryocath, LP2013-12-12
BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S409)Medtronic Cardiac Rhythm Disease Management2013-12-12
TRANSVENE CS/SVC LEAD (P980050/S088)Medtronic, Inc.2013-12-12
RESOLUTE INTERGRITY RX ZOTAROLIMUS-ELUTING CORONARY SYSTEM, RESOLUTE INTEGRITY OTW ZOTAROLIMUS-ELUTING CORONARY SYSTEM (P110013/S021)Medtronic Vascular2013-12-12
INTEGRITY CORONARY STENT SYSTEMS (P030009/S070)Medtronic, Ireland2013-12-12
ENVEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S083)Medtronic, Inc.2013-12-12
RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S029)Medtronic Vascular2013-12-12
BRAVA CRT-D, VIVA S CRT-D, VIVA CRT-D (P010031/S411)Medtronic Cardiac Rhythm Disease Management2013-12-12
EVERA S DR ICD, EVERA S VR, EVERA S VR ICD, EVERA XT DR ICD AND EVERA VR ICD (P980016/S449)Medtronic Cardiac Rhythm Disease Management2013-12-12
CAPSUREFIX LEAD (P930039/S097)Medtronic, Inc.2013-12-12
CAPSURE EPICARDIAL PACING LEAD (P950024/S055)Medtronic, Inc.2013-12-12
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S022)Boston Scientific Corporation2013-12-12
EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S447)Medtronic Cardiac Rhythm Disease Management2013-12-12
VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S014)Medtronic Vascular2013-12-12
CAPSURE SENSE LEAD,VITATRON CRYSTALLINE LEAD (P830061/S101)Medtronic Cardiac Rhythm Disease Management2013-12-12
VERSATRAX PACING SYSTEM (P820003/S123)Medtronic Cardiac Rhythm Disease Management2013-12-11
SYNERGYST II PACING SYSTEM (P890003/S281)Medtronic, Inc.2013-12-11
THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S055)Thoratec Laboratories Corp.2013-12-10
ADVISA DR MRI A2DR01 (P980035/S334)Medtronic, Inc.2013-12-06
EASYTRAK 2,EASYTRAK 3,ACUITY SPIRAL CRTS (P010012/S343)Boston Scientific Corp2013-12-06
REVO DR MRI RVDR01 (P090013/S105)Medtronic, Inc.2013-12-06
ACUITY STEERABLE CRTS (P050046/S022)Guidant Corp.2013-12-06
MAESTRO 3000 CARDIAC ABLATION SYSTEM (P020025/S049)Boston Scientific2013-12-05
ATTAIN ABILITY LV LEAD (P080006/S057)Medtronic, Inc.2013-12-05
MAESTRO 3000 CARDIAC ABLATION SYSTEM (P980003/S045)Boston Scientific Corp2013-12-05
GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006)W. L. Gore & Associates, Inc.2013-12-05
MAESTRO 3000 CARDIAC ABLATION SYSTEM (P920047/S063)Boston Scientific Corp2013-12-05
ACCENT DR, ACCENT DR RF, ACCENT SR, ACCENT SR RF PACEMAKERS (P880086/S236)ABBOTT MEDICAL2013-12-04
WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S049)Boston Scientific Corp2013-12-04
ANTHEM & ANTHEM RF CRT-P'S (P030035/S114)ABBOTT MEDICAL2013-12-04
WALLSTENT (VENOUS) ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S038)Boston Scientific Corporation2013-12-04
FINELINE II STEROX (P960004/S064)Boston Scientific2013-12-04
STRATOS LV AND LV-T CRT-P'S (P070008/S048)Biotronik, Inc.2013-12-03
LUMAX FAMILIES OF ICD'S (P050023/S070)Biotronik, Inc.2013-12-03
CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S- ICD SYSTEM (P110042/S021)Boston Scientific Corporation2013-12-03
INTELLA TIP MIFI XP ABLATION CATHETER (P020025/S050)Boston Scientific2013-12-03
LUMAX FAMILIES OF ICD'S & CRT-D'S (P050023/S071)Biotronik, Inc.2013-12-03
EVIA FAMILY OF PACEMAKERS (P950037/S130)Biotronik, Inc.2013-12-03
EVIA FAMILY OF PACEMAKERS (P950037/S129)Biotronik, Inc.2013-12-03
TRI VASCULAR, INC OVATION ABDOMINAL STENT GRAFT SYSTEM; TRI VASCULAR, INC OVATION PRIME ABDOMINAL ABDOMINAL STENT GRAFT (P120006/S008)Endologix, LLC2013-12-02
MULTI-LINK ULTRA RX AND OTW CORONARY STENT SYSTEMS (P970020/S077)Abbott Vascular, Inc.2013-11-26
CAPSURE EPICARDIAL PACING LEAD (P950024/S054)Medtronic, Inc.2013-11-26
ATTAIN BIPOLAR OTW LEAD , LEAD VENTRICULAR PACING LEAD (P010015/S226)Medtronic, Inc.2013-11-26
REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S085)MicroPort CRM USA, Inc.2013-11-26
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S019)Boston Scientific Corporation2013-11-26
EDWARD SAPIEN TRANSCATHETER HEART VALVE AND ACCESSIRUES (P110021/S029)Edwards Lifesciences, LLC2013-11-26
CELSIUS FLTR CATHETERS (P010068/S037)Biosense Webster, Inc.2013-11-26
CAPSURE FIX MRI LEAD (P090013/S120)Medtronic, Inc.2013-11-26
COGNIS,ENERGEN,INCEPTA,PUNCTUA CRT-DS (P010012/S342)Boston Scientific Corp2013-11-26
INVIVE,INTUA CRT-PS (P030005/S104)Guidant Corp.2013-11-26
Y ADAPTOR EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CIONNECTIR PORT PIN PLUG, LEAD ADAPTOR, SPRINT QUATTRO LEAD (P920015/S123)Medtronic, Inc.2013-11-26
BIOSENSE WEBSTER CELSIUS FLTR CATHETER (P950005/S048)Biosense Webster, Inc.2013-11-26
FORMIO,VITALIO,ADVANTIO,INGENIO,ALTRUA,INSIGNIA PACEMAKERS (N970003/S157)Boston Scientific Corp2013-11-26
ATTAIN STARFIX LEAD (P060039/S053)Medtronic, Inc.2013-11-26
UNIFY AND UNIFY QUADRA CRT-D'S (P030054/S253)ABBOTT MEDICAL2013-11-26
CAPSURE LEAD, SERVICE KIT PACEMAKER REPAIR KIT (P890003/S291)Medtronic, Inc.2013-11-26
FORTIFY VR/DR ICD'S (P910023/S322)ABBOTT MEDICAL2013-11-26
PARADYM VR/DR 8750, PARADYM RF VR/RF DR 9750 (P980049/S089)MicroPort CRM USA, Inc.2013-11-26
CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS+LEAD (P830061/S100)Medtronic Cardiac Rhythm Disease Management2013-11-26
CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATION IMPULSE II LEAD (P850089/S103)Medtronic Cardiac Rhythm Disease Management2013-11-26
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Every clearance here is in the API, with alerts when new ones post.