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Cardiovascular

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

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RecordFirmDate
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S108)Boston Scientific Corp2014-02-13
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S087)Boston Scientific Corp2014-02-13
ION PACLITAXEL-ELUTING C ORONAY STENT SYSTEM (P100023/S084)Boston Scientific Corp2014-02-13
EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S054)Boston Scientific Corp2014-02-13
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S068)Boston Scientific Corp2014-02-13
CHILLI COOLED ABLATION CATHETER AND CABLE (P980003/S046)Boston Scientific Corp2014-02-13
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S034)Edwards Lifesciences, LLC2014-02-12
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S047)Edwards Lifesciences, LLC2014-02-12
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM (P040036/S037)Biosense Webster, Inc.2014-02-11
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM (P030031/S053)Biosense Webster, Inc.2014-02-11
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR ( S-ICD) SYSTEM (P110042/S026)Boston Scientific Corporation2014-02-07
BLAZER PRIME XP AND INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S052)Boston Scientific2014-02-07
ARTIC FRONT CARDIC CRYOABLATION CATHETERS, ARTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS, FREEZOR MAX CARIAC CRYOAB (P100010/S033)Medtronic Cryocath, LP2014-02-07
FREEZOR CARDIAC CRYOABLATION CATHETER, ETRA SURGICAL CARDIAC CRYOABLATION DEVICE, MAX SURGICAL CARDIAC CRYOABLATION DEVI (P020045/S052)Medtronic Cryocath, LP2014-02-07
ARCTIC FRONT CARDIAC CRYOABLATION CATHETER, ARCTIC FRONT ADVANCED CARDIAC CRYOABALATION CATHETER (P100010/S034)Medtronic Cryocath, LP2014-02-07
FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CRYOABLATION DEVICE (P020045/S051)Medtronic Cryocath, LP2014-02-07
AFX ENDOVASCULAR AAA SYSTEM (P040002/S045)Endologix, LLC2014-02-06
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S085)Boston Scientific Corp2014-02-06
EXPRESS/EXPRESS2 MONORAIL AND OVER-THE-WIRE CONRONARY STENT SYSTEM (P020009/S116)Boston Scientific Scimed, Inc.2014-02-06
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OTW) (P110010/S067)Boston Scientific Corp2014-02-06
FORTIFY, FORTIFY ASSURA, AND ELLIPSE ICD'S (P910023/S325)ABBOTT MEDICAL2014-02-06
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S083)Boston Scientific Corp2014-02-06
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEM (P110010/S066)Boston Scientific Corp2014-02-06
UNIFY, UNIFY ASSURA, UNIFY QUADRA AND QUADRA ASSURA CRT-D'S (P030054/S256)ABBOTT MEDICAL2014-02-06
HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S034)Medtronic2014-02-06
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE -WIRE) (P100023/S086)Boston Scientific Corp2014-02-06
VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM (P040016/S122)Boston Scientific Scimed, Inc.2014-02-06
RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S007)Medtronic Vascular2014-02-05
RESOLUTE INTEGRITY RX ZOTAROLIMUS ELUTING CORONARY SYSTEM (P110013/S024)Medtronic Vascular2014-02-05
COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA (P110040/S003)Medtronic Vascular2014-02-05
MOSIAC PORCINE BIOPROSTHESIS (P990064/S053)Medtronic, Inc.2014-02-05
COMPLETE SE VASCULAR STENT SYSTEM-ILIAC (P090006/S013)Medtronic Vascular2014-02-05
BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S418)Medtronic Cardiac Rhythm Disease Management2014-02-04
CAPSUREFIX NOVUS LEAD (P930039/S103)Medtronic, Inc.2014-02-04
CAPSUREFIX MRI LEAD (P090013/S127)Medtronic, Inc.2014-02-04
CAPSURE LEAD (P830061/S106)Medtronic Cardiac Rhythm Disease Management2014-02-04
ADAPTA, VERSA SENSIA IPG (P980035/S363)Medtronic, Inc.2014-02-04
EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD (P980016/S456)Medtronic Cardiac Rhythm Disease Management2014-02-04
ENDEAVOR SPRINT ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM (P060033/S086)Medtronic, Inc.2014-02-03
RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM (P110013/S033)Medtronic Vascular2014-02-03
CAMERON HEALTH SUBCUTANCOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S025)Boston Scientific Corporation2014-01-31
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S037)Edwards Lifesciences, LLC2014-01-31
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S024)Edwards Lifesciences, LLC2014-01-31
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S020)Boston Scientific Corporation2014-01-31
RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM (P110013/S028)Medtronic Vascular2014-01-30
PERCLOSE PROGLIDE/PERCLOSE AT SUTURE MEDIATED CLOSURE SYSTEM (P960043/S086)Abbott Vascular, Inc.2014-01-30
ROTABLATOR ROTALINK ADVANCER AND ROTALINK PLUS (P900056/S130)Boston Scientific Corp2014-01-30
EXPRESS CORONARY STENT SYSTEM (P020009/S114)Boston Scientific Scimed, Inc.2014-01-29
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S053)Boston Scientific Corp2014-01-29
PERCLOSE PROGLIDE AND PERCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEMS (P960043/S085)Abbott Vascular, Inc.2014-01-29
EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S030)Boston Scientific Corporation2014-01-29
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S120)Boston Scientific Scimed, Inc.2014-01-29
PEARL 8.0 HANDPIECE (P970029/S025)Cryolife, Inc.2014-01-28
MITRACLIP CLIP DELIVERY SYSTEM (P100009/S002)ABBOTT MEDICAL2014-01-28
NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETER,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV CATH (P040036/S041)Biosense Webster, Inc.2014-01-24
AFX VELA PROXIMAL ENDOGRAFT DELIVERY SYSTEM (P040002/S044)Endologix, LLC2014-01-24
NAVISTAR ,NAVISTAR RMT ,EZ STEER NAV CATHETERS AND,BIOSENSE WEBSTER CABLES (P990025/S039)Biosense Webster, Inc.2014-01-24
ENDURANT STENT GRAFT SYSTEM (P100021/S027)Medtronic Vascular2014-01-24
MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S050)Cordis US Corporation2014-01-24
NAVISTAR RMT DS ,EZ STEER NAV DS ,CELSIUS FLTR, CELSIUS DS, & NAVISTAR DS CATHETERS (P010068/S038)Biosense Webster, Inc.2014-01-24
OPEN PIVOT HEART VALVE AND AORTIC VALVE GRAFT (P990046/S037)Medtronic Ats Medical, Inc.2014-01-24
CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CATHETER,EZ STEER DS CATHETER, DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS, (P950005/S049)Biosense Webster, Inc.2014-01-24
CELCIUS/ RMT THERMOCOOL ,NAVISTAR THERMOCOOL ,NAVISTAR RMT THERMOCOOL, THERMOCOOL, EZ STEER THERMOCOOL SF CATHETERS (P030031/S058)Biosense Webster, Inc.2014-01-24
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROTHESIS,CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICA (P860057/S116)Edwards Lifesciences, LLC2014-01-24
BIOSENSE WEBSTER CABLES (P990071/S025)Biosense Webster, Inc.2014-01-24
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOP (P860057/S117)Edwards Lifesciences, LLC2014-01-23
CARPENTIER-EDWARDS PORCINE AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROTHESIS (P870056/S064)Edwards Lifesciences, LLC2014-01-23
DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOSTHESIS WITH EXTENDED RING (P870077/S058)Edwards Lifesciences, LLC2014-01-23
CARPENTIER-EDWARDS SAV AORTIC PORCINE BIOPROSTHESIS (P010041/S047)Edwards Lifesciences, LLC2014-01-23
SPRINT QUATTRO LEADS, SPRINT FIDELIS (P920015/S122)Medtronic, Inc.2014-01-22
CAPSURE VDD-2 LEAD (P890003/S290)Medtronic, Inc.2014-01-22
REVO MRI IPG (P090013/S125)Medtronic, Inc.2014-01-22
CELSIUS FLTR CATHETER UNIDIRECTIONAL, CELSIUS FLTR CATHETER BIDIRECTIONAL (P950005/S047)Biosense Webster, Inc.2014-01-22
LIFESTENT VASCULAR STENT SYSTEM (P070014/S041)Bard Peripheral Vascular, Inc.2014-01-22
LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S047)Zoll Manufacturing Corporation2014-01-22
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S024)Boston Scientific Corporation2014-01-22
VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM (P100040/S012)Medtronic Vascular2014-01-22
CONSULTA CRT-P,SYNCRA CRT-P (P010015/S230)Medtronic, Inc.2014-01-22
COMPLETE SE VASCULAR STENT SYSTEM (P090006/S009)Medtronic Vascular2014-01-22
CELSIUS FLTR CATHER UNIDIRECTIONAL,CELSIUS FLTR CATHETER BIDIRECTIONAL (P010068/S036)Biosense Webster, Inc.2014-01-22
BARD E-LUMINEXX VASCULAR STENT (P080007/S019)Bard Peripheral Vascular, Inc.2014-01-22
ADAPTA,VERSA,SENSIA IPG, ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG (P980035/S361)Medtronic, Inc.2014-01-22
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S107)Boston Scientific Corp2014-01-21
LUMAX 3XO/5X10 (P050023/S073)Biotronik, Inc.2014-01-17
MEDTRONIC COREVALVE SYSTEM (P130021)Medtronic, Inc.2014-01-17
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S089)W. L. Gore & Associates, Inc.2014-01-17
LINOX (P980023/S054)Biotronik, Inc.2014-01-17
ETHICON OMNEX SURGICAL SEALANT (P060029/S005)ETHICON, Inc.2014-01-17
CAPSURE SENSE LEAD,CAPSURE SP NOVUS LEAD,VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+LEAD (P830061/S105)Medtronic Cardiac Rhythm Disease Management2014-01-16
TRANSVENE CS/SVC LEAD (P980050/S090)Medtronic, Inc.2014-01-16
CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,VITATRON IMPULSE II LEAD (P850089/S105)Medtronic Cardiac Rhythm Disease Management2014-01-16
ADVISA DR IPG,ADVISA DR MRI IPG (P980035/S362)Medtronic, Inc.2014-01-16
ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P,SYNCRA CRT-P (P010015/S228)Medtronic, Inc.2014-01-16
BRAVA CRT-D; CONCERTO II CRT-D; CONSULTA ICD,MAXIMO II CRT-D, PROTECTA XI C RT-D, VIVA S/X CRT-D; (P010031/S415)Medtronic Cardiac Rhythm Disease Management2014-01-16
PERCLOSE PROGLIDE/PERCLOSE AT SUTURE MEDIATED CLOSURE SYSTEMS AND SNARED KNOT PUSHER (P960043/S083)Abbott Vascular, Inc.2014-01-16
DISPOSABLE EPG COVER; DUAL CHAMBER TEMPORARY PACEMANKER; SINGLE CHAMBER TEMPORARY PACEMAKER (P820003/S126)Medtronic Cardiac Rhythm Disease Management2014-01-16
CAPSURE SENSE, SP, SP NOVUS LEADS, VITATRON CRYSTALLINE & EXCELLENCE PS LEADS (P830061/S104)Medtronic Cardiac Rhythm Disease Management2014-01-16
ADAPTA, VERSA, SENSIA IPG, ADVISA DR/DR MRI IPG; RELIA IPG (P980035/S359)Medtronic, Inc.2014-01-16
CAPSUREFIX MRI LEAD,REVO MRI IPG (P090013/S126)Medtronic, Inc.2014-01-16
APPLICATION SOFTWARE CAPSUREFIX MRI LEAD REVO MRI IPG (P090013/S123)Medtronic, Inc.2014-01-16
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