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Cardiovascular

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

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RecordFirmDate
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S052)Medtronic, Inc.2010-06-23
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P060008/S055)Boston Scientific Corp2010-06-23
BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S016)Bard Peripheral Vascular, Inc.2010-06-23
BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S015)Bard Peripheral Vascular, Inc.2010-06-23
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S187)ABBOTT MEDICAL2010-06-23
BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S017)Bard Peripheral Vascular, Inc.2010-06-23
CURRENT, CURRENT+, CURRENT ACCEL AND FORTIFY CRT-D'S (P910023/S232)ABBOTT MEDICAL2010-06-22
DURATA FAMILY OF LEADS (P950022/S070)ABBOTT MEDICAL2010-06-22
PROMOTE, PROMOTE+, PROMOTE ACCEL AND UNIFY CRT-D'S AND LEADS AND MERLIN PROGRAMMER (P030054/S148)ABBOTT MEDICAL2010-06-22
MULTI-LINK 8 AND MULTI-LINK 8 LL CORONARY STENT SYSTEM (P020047/S017)Abbott Vascular2010-06-22
CARDIOMESSENGER-S AND CARDIOMESSENGER-S TLINE (P950037/S081)Biotronik, Inc.2010-06-18
CARDIOMESSENGER-S AND CARDIOMESSENGER-S TLINE (P050023/S031)Biotronik, Inc.2010-06-18
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S188)ABBOTT MEDICAL2010-06-18
PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S009)Medtronic Vascular, Inc.2010-06-18
MICRONY FAMILY OF PACEMAKERS (P970013/S033)ABBOTT MEDICAL2010-06-18
TALENT TAA STENT GRAFT DELIVERY SYSTEM (P070007/S018)Medtronic Vascular2010-06-18
THE TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S017)Medtronic Vascular2010-06-18
CADENCE FAMILY OF ICDS (P910023/S235)ABBOTT MEDICAL2010-06-18
TALENT AAA STENT GRAFT DELIVERY SYSTEM (P070027/S018)Medtronic Vascular2010-06-18
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S066)St. Jude Medical, Inc.2010-06-18
EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S152)ABBOTT MEDICAL2010-06-18
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S069)ABBOTT MEDICAL2010-06-18
ELA MEDICAL'S REPLY PACEMAKERS (P950029/S048)MicroPort CRM USA, Inc.2010-06-18
XC202 CERAMIC CAPACITOR (P980035/S153)Medtronic, Inc.2010-06-18
REPLY (V2) AND ESPRIT DEVICES (P950029/S049)MicroPort CRM USA, Inc.2010-06-18
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S054)Boston Scientific Corp2010-06-18
5F & 6/7F MYNX VASCULAR CLOSURE DEVICE (P040044/S032)Cordis US Corporation2010-06-17
ATS 3F AORTIC BIOPROSTHESIS MODEL 100 (P060025/S006)Medtronic, Inc.2010-06-17
ATTAIN ABILITY (P080006/S008)Medtronic, Inc.2010-06-16
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S070)Cordis Corp.2010-06-15
LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS (P070014/S007)Bard Peripheral Vascular, Inc.2010-06-11
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S037)Abbott Vascular, Inc.2010-06-11
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S035)Boston Scientific Corp2010-06-11
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S047)Boston Scientific Scimed, Inc.2010-06-11
TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S080)Boston Scientific Corp2010-06-11
BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S009)Bard Peripheral Vascular, Inc.2010-06-11
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S046)Medtronic, Inc.2010-06-11
EXPRESS LD LLIAC PERMOUNTED STENT SYSTEM (P090003/S002)Boston Scientific Corporation2010-06-11
TENDRIL STS MODELS 2088TC & 1988TC LEADS (P960013/S060)ABBOTT MEDICAL2010-06-10
BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S008)Bard Peripheral Vascular, Inc.2010-06-09
LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S020)Zoll Manufacturing Corporation2010-06-09
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S047)Medtronic, Inc.2010-06-04
GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S104)Medtronic, Ireland2010-06-04
DRIVER & MICRODRIVER CORONARY STENT SYSTEMS (P030009/S038)Medtronic, Ireland2010-06-04
STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S026)Abbott Vascular Devices2010-06-03
CONCERTO II/CONSULTA/MAXIMO II CRT-DS (P010031/S197)Medtronic Cardiac Rhythm Disease Management2010-06-03
SECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS (P980016/S239)Medtronic Cardiac Rhythm Disease Management2010-06-03
KAPPA 400 DR/SR IPG (P970012/S067)Medtronic, Inc.2010-06-02
INSYNC/MARQUIS/II & III MARQUIS/II PROTECT/SENTRY/MAXIMO ICDS & CONCERTO/CONCERTO II/MAXIMO II/CONSULTA CRT-DS (P010031/S196)Medtronic Cardiac Rhythm Disease Management2010-06-02
KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS (P980035/S167)Medtronic, Inc.2010-06-02
GEM/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/SECURA DR/VR (P980016/S238)Medtronic Cardiac Rhythm Disease Management2010-06-02
INSYNC CRT-P & INSYNC III CRT-P (P010015/S085)Medtronic, Inc.2010-06-02
DEMA IPG/C & T SERIES IPGS (P990001/S067)Medtronic, Inc.2010-06-02
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S237)Advanced Cardiovascular Systems, Inc.2010-06-01
MOSAIC PORCINE BIOPROSTHESIS MODELS 305/310/305U (P990064/S033)Medtronic, Inc.2010-05-28
AMPLATZER SEPTAL OCCLUDER (P000039/S036)ABBOTT MEDICAL2010-05-28
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S006)Boston Scientific Corp2010-05-28
HANCOCK II PORCINE BIOPROSTHESIS MODELS T505/T510 (P980043/S026)Medtronic, Inc.2010-05-28
HANCOCK I LOW POROSITY & MODIFIED ORIFICE VALVED CONDUIT MODEL 150 (P790007/S025)Medtronic Heart Valves2010-05-28
HANCOCK PORCINE BIOPROSTHESIS (P870078/S009)Medtronic, Inc.2010-05-28
FREESTYLE AORTIC ROOT BIOPROSTHESIS MODELS 995/955CS/995MS (P970031/S029)Medtronic, Inc.2010-05-28
AMPLATZER DUCT OCCLUDER (P020024/S029)ABBOTT MEDICAL2010-05-28
AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S013)ABBOTT MEDICAL2010-05-28
CELSIUS RMT THERMOCOOL CATHETER (P040036/S022)Biosense Webster, Inc.2010-05-27
NAVISTAR RMT THERMOCOOL CATHETER (P030031/S029)Biosense Webster, Inc.2010-05-27
APEX PTCA DILATATION CATHETER (P860019/S255)Scimed Life Systems, Inc.2010-05-27
PARADYM CRT 8750 (P060027/S023)MicroPort CRM USA, Inc.2010-05-26
SYMPHONY SR 2250 & DR 2550/RHAPSODY SR 2210/DR 2510/2530 & REPLY SR/DR & ESPRIT SR/DR (P950029/S052)MicroPort CRM USA, Inc.2010-05-26
PARADYM VR/DR (P980049/S056)MicroPort CRM USA, Inc.2010-05-26
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S033)W. L. Gore & Associates, Inc.2010-05-25
CONTAK RENEWAL TR (P030005/S062)Guidant Corp.2010-05-21
LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S019)Zoll Manufacturing Corporation2010-05-21
PROMUS & XIENCE V OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S035)Abbott Vascular, Inc.2010-05-21
STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S025)Abbott Vascular Devices2010-05-21
ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM (P990020/S039)Medtronic Vascular2010-05-21
RELIANCE LEADS (P910073/S083)Boston Scientific2010-05-21
MULTILINK VISION & MULTI LINK MINI VISION OTW CORONARY STENT SYSTEMS (P020047/S019)Abbott Vascular2010-05-21
CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) (P030005/S064)Guidant Corp.2010-05-20
CONTAK RENEWAL 3 AND LIVIAN FAMILIES OF CRT-DS (P010012/S242)Boston Scientific Corp2010-05-20
PULSE GENERATOR (P010012/S243)Boston Scientific Corp2010-05-20
CONFIENT AND VITALITY FAMILIES OF ICDS (P960040/S223)Boston Scientific2010-05-20
DUAL-CHAMBER ADAPTIVE-RATE PACEMAKER (P940031/S067)Boston Scientific2010-05-20
CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL 3 RF, CONTAK RENEWAL 3 RF HE, LIVIAN SE, LIVIAN HE (P010012/S241)Boston Scientific Corp2010-05-19
LIVIAN/RENEWAL 3/RENEWAL 3RF/RENEWAL 3 AVT PULSE GENERATOR FAMILIES (P010012/S240)Boston Scientific Corp2010-05-19
MODEL 3120 ZOOM LATITUDE PROGRAMMER (P910077/S104)Boston Scientific2010-05-19
CONTAK RENEWAL TR FAMILY OF CRT-PS (P030005/S063)Guidant Corp.2010-05-19
CAPSURE SENSE/VITATRON (P830061/S051)Medtronic Cardiac Rhythm Disease Management2010-05-19
OPTISENSE 1999 LEAD (P960013/S058)ABBOTT MEDICAL2010-05-19
CONFIENT AND VITALITY HE FAMILIES OF PULSE GENERATORS (P960040/S221)Boston Scientific2010-05-19
VENTAK PRIZM, VENTAK PRIZM 2, VITALITY, VITALITY HE, VITALITY 2, VITALITY AVT, AND CONFIENT FAMILIES OF ICDS (P960040/S222)Boston Scientific2010-05-19
CAPSUREFIX NOVUS/VITATRON (P930039/S037)Medtronic, Inc.2010-05-19
BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S006)Bard Peripheral Vascular2010-05-18
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S047)Boston Scientific Corp2010-05-17
MEDTRONIC MODEL 2090 & 2090X CARELINK PROGRAMMER (P890003/S190)Medtronic, Inc.2010-05-14
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S034)Abbott Vascular, Inc.2010-05-14
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P060008/S049)Boston Scientific Corp2010-05-13
DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S041)Medtronic, Ireland2010-05-13
HANCOCK II BIOPROSTHESIS MODEL T505 (P980043/S025)Medtronic, Inc.2010-05-13
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S057)Boston Scientific Scimed, Inc.2010-05-13
MOSAIC PORCINE BIOPROSTHESIS MODEL 305 (P990064/S032)Medtronic, Inc.2010-05-13
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