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Cardiovascular

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

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RecordFirmDate
CADENCE FAMILY OF ICDS (P910023/S238)ABBOTT MEDICAL2010-07-21
EPIC HF/ATLAS+HF FAMILY OF CRT-DS (P030054/S156)ABBOTT MEDICAL2010-07-21
MULTI-LINK/VISION/MINI VISION FAMILY OF CORONARY STENT SYSTEMS (P020047/S021)Abbott Vascular2010-07-20
MULTI-LINK ZETA CORONARY STENT SYSTEMS (CSS) (P970020/S056)Abbott Vascular, Inc.2010-07-20
XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S040)Abbott Vascular, Inc.2010-07-20
ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM IPGS (P980035/S174)Medtronic, Inc.2010-07-16
VITATRON (P990001/S063)Medtronic, Inc.2010-07-16
SIGMA/MEDTRONIC 350 SERIES/ENRHYTHM IPG/ADAPTA/SENSIA/RELIA/VERSA (P980035/S160)Medtronic, Inc.2010-07-16
COROX OTW STEROID LV LEAD MONITORING (COSMO) (P050023/S035)Biotronik, Inc.2010-07-16
INSYNC III (IPG) (P010015/S081)Medtronic, Inc.2010-07-16
SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/ENTRUST/VIRTUOSO (P980016/S230)Medtronic Cardiac Rhythm Disease Management2010-07-16
SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR VIRTUOSO ICDS (P980016/S247)Medtronic Cardiac Rhythm Disease Management2010-07-16
CONSULTA/MAXIMO II/CONCERTO II/CONCERTO CRT-DS (P010031/S189)Medtronic Cardiac Rhythm Disease Management2010-07-16
CONCERTO II/CONSULTA/MAXIMO II CRT-DS/CONCERTO (P010031/S203)Medtronic Cardiac Rhythm Disease Management2010-07-16
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S191)ABBOTT MEDICAL2010-07-16
KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS (P980035/S169)Medtronic, Inc.2010-07-15
DEMA IPG/C & T SERIES IPGS (P990001/S069)Medtronic, Inc.2010-07-15
DURATA FAMILY OF LEADS (P950022/S071)ABBOTT MEDICAL2010-07-15
ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN (P900061/S089)Medtronic Cardiac Rhythm Disease Management2010-07-15
CADENCE FAMILY OF ICDS (P910023/S237)ABBOTT MEDICAL2010-07-15
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S190)ABBOTT MEDICAL2010-07-15
KAPPA 400 DR/SR IPG (P970012/S069)Medtronic, Inc.2010-07-15
SPECTRANETICS SLS II LASER SHEATH (P960042/S017)Spectranetics (Philips)2010-07-15
ZENITH FLEX AAA ENDOVASCULAR GRAFT & ZENITH RENU AAA ANCILLARY GRAFT WITH Z-TRAK INTRODUCTION SYSTEM (P020018/S036)Cook, Inc.2010-07-15
MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P850051/S073)Medtronic, Inc.2010-07-15
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S062)Terumo Medical Corporation2010-07-15
CONCERTO II/CONSULTA/MAXIMO II CRT-DS (P010031/S199)Medtronic Cardiac Rhythm Disease Management2010-07-15
EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S004)Boston Scientific Corporation2010-07-15
EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S154)ABBOTT MEDICAL2010-07-15
INSYNC CRT-P & INSYNC III CRT-P (P010015/S087)Medtronic, Inc.2010-07-15
SECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS (P980016/S241)Medtronic Cardiac Rhythm Disease Management2010-07-15
SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (P890003/S193)Medtronic, Inc.2010-07-15
JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD (P980050/S049)Medtronic, Inc.2010-07-15
CELSIUS THERMOCOOL CATHETER (P030031/S030)Biosense Webster, Inc.2010-07-15
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S071)ABBOTT MEDICAL2010-07-15
ATS 3F AORTIC BIOPROSTHESIS MODEL 1000 (P060025/S005)Medtronic, Inc.2010-07-13
EPIC HF CRT-D SYSTEM (P030054/S149)ABBOTT MEDICAL2010-07-09
MYNX VASCULAR CLOSURE DEVICE (P040044/S025)Cordis US Corporation2010-07-09
CADENCE ICD SYSTEM (P910023/S233)ABBOTT MEDICAL2010-07-09
PARADYM CRT (P060027/S025)MicroPort CRM USA, Inc.2010-07-09
PARADYM DR/VR (P980049/S058)MicroPort CRM USA, Inc.2010-07-09
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S069)Edwards Lifesciences, LLC2010-07-09
ATTAIN ABILITY (P080006/S009)Medtronic, Inc.2010-07-08
MEDTRONIC VASULAR TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S020)Medtronic Vascular2010-07-08
ATTAIN STARFIX (P060039/S012)Medtronic, Inc.2010-07-08
ENTRUST (P980016/S246)Medtronic Cardiac Rhythm Disease Management2010-07-08
ENRHYTHM IPG (P980035/S172)Medtronic, Inc.2010-07-08
TAXUS LIBERTE & TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P060008/S056)Boston Scientific Corp2010-07-08
SELECTSECURE (P030036/S017)Medtronic Cardiac Rhythm Disease Management2010-07-08
ATTAIN OTW & ATTAIN BIPOLAR OTW (P010015/S090)Medtronic, Inc.2010-07-08
CVX-300 LASER SYSTEM (P910001/S033)Spectranetics Corp.2010-07-08
VERIFLEX (LIBERTE) STENT DELIVERY SYSTEM (P040016/S060)Boston Scientific Scimed, Inc.2010-07-08
MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S007)Corcym Canada Corp2010-07-08
MEDTRONIC VASCULAR TALENT THORACIC STENT GRAFT SYSTEM (P070007/S020)Medtronic Vascular2010-07-08
EZ STEER THERMOCOOL NAV CATHETER (P030031/S022)Biosense Webster, Inc.2010-07-07
EZ STEER THERMOCOOL NAV CATHETER (P040036/S015)Biosense Webster, Inc.2010-07-07
ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR SECURA DR/VR ICDS (P980016/S245)Medtronic Cardiac Rhythm Disease Management2010-07-07
CONCERTO/CONSULTA CRT-DS/CONCERTO II ICD/MAXIMO II CRT-D (P010031/S202)Medtronic Cardiac Rhythm Disease Management2010-07-07
LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S016)Zoll Manufacturing Corporation2010-07-02
DRIVER & MICRODRIVER CORONARY STENT SYSTEMS (P030009/S043)Medtronic, Ireland2010-07-01
TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S019)Medtronic Vascular2010-07-01
TALENT THORACIC STENT GRAFT SYSTEM (P070007/S019)Medtronic Vascular2010-07-01
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S056)Medtronic, Inc.2010-07-01
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S053)Medtronic, Inc.2010-07-01
GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S108)Medtronic, Ireland2010-07-01
ANEURX STENT GRAFT SYSTEM (P990020/S040)Medtronic Vascular2010-07-01
ADAPTA/SENSIA/VERSA/RELIA/ENRHYTHM IPGS (P980035/S171)Medtronic, Inc.2010-06-30
INSYNC III CRT-P (P010015/S089)Medtronic, Inc.2010-06-30
MEDTRONIC ATTAIN STARFIX MODEL 4195 LEAD (P060039/S010)Medtronic, Inc.2010-06-30
ST JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S071)ABBOTT MEDICAL2010-06-30
BLAZER PRIME HTD CATHETER (P920047/S042)Boston Scientific Corp2010-06-30
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S055)Medtronic, Inc.2010-06-30
INSYNC ICD MODEL 7272 (P010031/S201)Medtronic Cardiac Rhythm Disease Management2010-06-30
SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR ICDS (P980016/S244)Medtronic Cardiac Rhythm Disease Management2010-06-30
BLAZER PRIME XP CATHETER (P020025/S023)Boston Scientific2010-06-30
OVATIO CRT-D AND PARADYM CRT-D (P060027/S024)MicroPort CRM USA, Inc.2010-06-28
NAVISTAR RMT THERMOCOOL CATHETER (P030031/S024)Biosense Webster, Inc.2010-06-28
CADENCE ICDS (P910023/S229)ABBOTT MEDICAL2010-06-28
OVATIO VR/DR AND PARADYM VR/DR ICDS (P980049/S057)MicroPort CRM USA, Inc.2010-06-28
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P060008/S013)Boston Scientific Corp2010-06-28
CELSIUS RMT THERMOCOOL CATHETER (P040036/S017)Biosense Webster, Inc.2010-06-28
REPLY / ESPRIT PACEMAKERS (P950029/S053)MicroPort CRM USA, Inc.2010-06-28
EPIC HF CRT-DS (P030054/S144)ABBOTT MEDICAL2010-06-28
RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER (P020052/S006)St Jude Medical2010-06-25
DA+ C-SERIES AND DA+ T-SERIES (P990001/S070)Medtronic, Inc.2010-06-25
KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS (P980035/S170)Medtronic, Inc.2010-06-25
INSYNC CRT-P & INSYNC III CRT-P (P010015/S088)Medtronic, Inc.2010-06-25
LIVEWIRE TC AND SAFIRE ABLATION CATHETERS (P960016/S029)St Jude Medical2010-06-25
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S079)Cordis Corp.2010-06-24
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERCARDIAL BIOPRSTHESIS MODELS 7300 AND 7300TFX (P860057/S068)Edwards Lifesciences, LLC2010-06-24
GORE VIABAHN ENDOPROSTHESIS (P040037/S026)W. L. Gore & Associates, Inc.2010-06-23
SECURA VR/MAXIMO II VR/VIRTUOSO II VR (P980016/S243)Medtronic Cardiac Rhythm Disease Management2010-06-23
EXPRESS2 STENT DELIVERY SYSTEM (P020009/S064)Boston Scientific Scimed, Inc.2010-06-23
MULTI-LINK MINI VISION CORONARY STENT SYSTEMS (P020047/S020)Abbott Vascular2010-06-23
VERIFLEX (LIBERTÉ) CORONARY STENT SYSTEM (P040016/S058)Boston Scientific Scimed, Inc.2010-06-23
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S068)ABBOTT MEDICAL2010-06-23
CADENCE FAMILY OF ICDS (P910023/S234)ABBOTT MEDICAL2010-06-23
MAVERICK2 MONORAIL & MAVERICK OTW PTCA DILATATION CATHETERS (P860019/S256)Scimed Life Systems, Inc.2010-06-23
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S100)Boston Scientific Corp2010-06-23
EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S151)ABBOTT MEDICAL2010-06-23
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