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Cardiovascular

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

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RecordFirmDate
EPIC + HF, ATLAS + HF, EPIC II + HF, ATLAS II + HF CARDIAC RESYNCHRONIZATION DEFIBRILLATORS (P030054/S034)ABBOTT MEDICAL2007-02-02
NIRFLEX PREMOUNTED CORONARY STENT SYSTEM (P020040/S003)Medinol, Ltd.2007-02-02
SELECTED MODELS OF DUAL CHAMBER ICD DEVICES (P000009/S021)Biotronik, Inc.2007-01-30
SELECTED MODELS OF IPG BRADY CARDIA DEVICES (P950037/S047)Biotronik, Inc.2007-01-30
SELECTED MODELS OF SINGLE CHAMBER ICD DEVICES (P980023/S026)Biotronik, Inc.2007-01-30
VARIOUS PAVEMAKERS, CARELINK MONITOR, CARDIOSIGHT READER (P890003/S115)Medtronic, Inc.2007-01-30
INSYNC MARQUIS/SENTRY/MAXIMO/CONCERTO & VIRTUOSO CRT-ICDS (P010031/S061)Medtronic Cardiac Rhythm Disease Management2007-01-30
SELECTED FAMILIES OF PACEMAKERS (P980035/S071)Medtronic, Inc.2007-01-30
AMPLATZER DUCT OCCLUDER (P020024/S014)ABBOTT MEDICAL2007-01-30
AMPLATZER SEPTAL OCCLUDER (P000039/S020)ABBOTT MEDICAL2007-01-30
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROTHESIS (P870077/S022)Edwards Lifesciences, LLC2007-01-29
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S038)Edwards Lifesciences, LLC2007-01-29
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S011)Edwards Lifesciences, LLC2007-01-29
CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS (P010041/S011)Edwards Lifesciences, LLC2007-01-29
STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESIS (P870038/S009)Edwards Lifesciences, LLC2007-01-29
CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S024)Edwards Lifesciences, LLC2007-01-29
CONTAK RENEWAL RF PULSE GENERATORS (P010012/S102)Boston Scientific Corp2007-01-26
LINOX S & LINOX T IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS (P980023/S027)Biotronik, Inc.2007-01-26
XACT CAROTID STENT SYSTEM (P040038/S009)Abbott Vascular, Inc.2007-01-25
POSSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM-SPIROFLEX CATHETER (P980037/S017)Boston Scientific Corp2007-01-25
VARIOUS INSYNC FAMILIES OF CRT-ICDS (P010031/S049)Medtronic Cardiac Rhythm Disease Management2007-01-24
PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS (P060001)Medtronic Vascular, Inc.2007-01-24
ENRHYTHM (IPG) (P980035/S060)Medtronic, Inc.2007-01-24
SELECTED FAMILIES OF ICDS (P980016/S082)Medtronic Cardiac Rhythm Disease Management2007-01-24
MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT (P790018/S047)Medtronic Cardiac Surgery2007-01-24
STARR-EDWARDS SILASTIC BALL HEART VALVE, MODELS 1260 AND 6120 (P870038/S011)Edwards Lifesciences, LLC2007-01-19
CADENCE FAMILY ICDS (P910023/S130)ABBOTT MEDICAL2007-01-19
XACT CAROTID STENT SYSTEM (P040038/S008)Abbott Vascular, Inc.2007-01-19
EPIC HF FAMILY CRT-DS (P030054/S048)ABBOTT MEDICAL2007-01-19
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S012)Edwards Lifesciences, LLC2007-01-18
POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER (P040002/S008)Endologix, LLC2007-01-18
BIOPROSTHESIS MODEL 2625,6625, VALVED CONDUIT MODEL 4300 (P870056/S025)Edwards Lifesciences, LLC2007-01-18
PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S039)Edwards Lifesciences, LLC2007-01-18
SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODELS 2650,6650 (P010041/S012)Edwards Lifesciences, LLC2007-01-18
DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S023)Edwards Lifesciences, LLC2007-01-18
RX ACCULINK & ACCULINK CAROTID STENT SYSTEMS (P040012/S025)Abbott Vascular2007-01-18
SILASTIC BALL HEART VALVE PROSTHESIS (P870038/S010)Edwards Lifesciences, LLC2007-01-18
MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S023)Medtronic Vascular2007-01-18
STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S002)Abbott Vascular Devices2007-01-16
ST JUDE MEDICAL ICDS & CRT-DS (P910023/S129)ABBOTT MEDICAL2007-01-11
ST JUDE MEDICAL ICDS & CRT-DS (P030054/S047)ABBOTT MEDICAL2007-01-11
KAPPA 700 IPG, KAPPA 900 IPG, ENPULSE IPG, ADAPATA/ VERSA/ SENSIA IPG (P980035/S070)Medtronic, Inc.2007-01-11
INSYNC ICD (P010031/S060)Medtronic Cardiac Rhythm Disease Management2007-01-11
VIRTUOSO ICDS (P980016/S093)Medtronic Cardiac Rhythm Disease Management2007-01-11
POSSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM-ANGIOJET XMI-RX+CATHETER (P980037/S013)Boston Scientific Corp2007-01-10
THERAPY ABLATION CATHETERS (P040014/S004)Irvine Biomedical, Inc.2007-01-10
CYPHER SIROLIMUS-ELUTING CORONARY STENTS ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM (P020026/S030)Cordis Corp.2007-01-10
THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR (P040042/S006)Irvine Biomedical,Inc.(Ibi)2007-01-10
ANGIOSCULPT SCORING BALLOON CATHETER (P050018)Spectranetics Corp.2007-01-08
PERIMOUNT, PERIMOUNT MAGNA AND PERIMOUNT PLUS PERCARDIAL BIOPROSTHESES (P860057/S036)Edwards Lifesciences, LLC2007-01-08
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S012)W. L. Gore & Associates, Inc.2007-01-05
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S018)W. L. Gore & Associates, Inc.2007-01-05
RX ACCULINK & ACCULINK CAROTID STENT SYSTEMS (P040012/S020)Abbott Vascular2007-01-05
VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT (P990037/S024)Vascular Solutions, Inc.2006-12-22
VITALITY (P960040/S139)Boston Scientific2006-12-21
VITALITY (P960040/S137)Boston Scientific2006-12-21
AFFINITY/ENTITY/IDENTITY ADX/INTREGRITY/INTEGRITY MICRO/VERITY ADX PACEMAKERS (P880086/S126)ABBOTT MEDICAL2006-12-21
CONTAK RENEWAL 3 (P010012/S144)Boston Scientific Corp2006-12-21
FRONTIER BIVENTRICULAR PACEMAKERS (P030035/S019)ABBOTT MEDICAL2006-12-21
LIBERTE CORONARY STENT SYSTEM (P040016/S012)Boston Scientific Scimed, Inc.2006-12-21
BLAZER II CARDIAC ABLATION CATHETER AND STEEROCATH-T CARDIAC ABLATION CATHETER (P920047/S036)Boston Scientific Corp2006-12-21
BLAZER II XP CATHETERS (P020025/S018)Boston Scientific2006-12-21
CONTAK RENEWAL (P010012/S145)Boston Scientific Corp2006-12-21
KAPPA 400 MEDTRONIC IMPLANTABLE PULSE GENERATORS (P970012/S026)Medtronic, Inc.2006-12-21
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S033)Boston Scientific Corp2006-12-21
KAPPA 700, KAPPA 900, ENPULSE, ADAPTA/VERSA/ SENSIA (P980035/S067)Medtronic, Inc.2006-12-21
ST JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S061)ABBOTT MEDICAL2006-12-20
TAXUS EXPRESS PACLITAXEL- ELUTING CORONARY STENT SYSTEM (P030025/S041)Boston Scientific Corp2006-12-20
CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM & EPIC HF (P030054/S046)ABBOTT MEDICAL2006-12-14
ENRHYTHM IMPLANTABLE PULSE GENERATOR AND ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980035/S068)Medtronic, Inc.2006-12-14
ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR, EPIC II/II+ DR/VR/HR, ATLAS, ATLAS+, AND ATLAS II/II+ ICD SYSTEMS (P910023/S128)ABBOTT MEDICAL2006-12-14
ENRHYTHM IMPLANTABLE PULSE GENERATOR AND ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980016/S091)Medtronic Cardiac Rhythm Disease Management2006-12-14
ST. JUDE MEDICAL HOUSECALL PLUS SYSTEM (P910023/S127)ABBOTT MEDICAL2006-12-14
RIATA LEAD MODELS 1580, 1581 AND 1582; RIATA, RIATA ST AND RIATA ST OPTIM LEAD FAMILIES (P950022/S032)ABBOTT MEDICAL2006-12-14
RX ACCULINK & ACCULINK CAROTID STENT SYSTEM (P040012/S024)Abbott Vascular2006-12-14
FLEXTOME CUTTING BALLOON MONORAIL & OVER-THE-WIRE (P950020/S022)Boston Scientific Corp2006-12-14
GORE HELEX SEPTAL OCCLUDER (P050006/S002)W. L. Gore & Associates, Inc.2006-12-13
ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS (P030054/S045)ABBOTT MEDICAL2006-12-13
ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS (P910023/S126)ABBOTT MEDICAL2006-12-13
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S035)Boston Scientific Corp2006-12-11
PIN PLUG, DF-1 Y-ADAPTER/ EXTENDER, LEAD ASSEMBLY SILICONE DEFIBRILLATOR (P920015/S036)Medtronic, Inc.2006-12-11
TENDRIL 1688T/TC LEADS (P960013/S024)ABBOTT MEDICAL2006-12-11
CORONARY DILATATION CATHETERS (P810046/S220)Advanced Cardiovascular Systems, Inc.2006-12-11
LIBERTE MR & OTW CORONARY STENT SYSTEM (P040016/S016)Boston Scientific Scimed, Inc.2006-12-11
ACTIVE CAN EMULATOR CONNECTOR, TRANSVERSE EPICARDIAL DEFIBRILLATION LEAD, LEAD SLEEVE ADAPTER KIT (P900061/S070)Medtronic Cardiac Rhythm Disease Management2006-12-11
VOYAGER RX CORONARY DILATATION CATHETER (P810046/S221)Advanced Cardiovascular Systems, Inc.2006-12-11
FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM (P890043/S039)Abbott Vascular2006-12-11
EXPRESS2 CORONARY STENT SYSTEM (P020009/S029)Boston Scientific Scimed, Inc.2006-12-11
LEGACY SR IPG (P850051/S064)Medtronic, Inc.2006-12-11
LEGACY DR, WRENCH ACCESSORY KIT (P890003/S113)Medtronic, Inc.2006-12-11
VASCULAR DRIVER MX2 CORONARY STENT SYSTEM& MIRCODRIVER MX2 CORONARY STENT SYSTEM (P030009/S008)Medtronic, Ireland2006-12-08
CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S031)Cordis Corp.2006-12-07
LUMAX FAMILY OF ICDS/CRT-DS (P000009/S020)Biotronik, Inc.2006-12-07
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S032)Cordis Corp.2006-12-07
LUMAX FAMILY OF ICDS/CRT-DS (P050023/S001)Biotronik, Inc.2006-12-07
ANGIOJET ULTRA THROMBECTOMY SYSTEM (P980037/S014)Boston Scientific Corp2006-12-07
LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P950037/S046)Biotronik, Inc.2006-12-07
LUMAX FAMILY OF ICDS/CRT-DS (P980023/S025)Biotronik, Inc.2006-12-07
MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P910077/S067)Boston Scientific2006-12-06
ZENITH AAA ENDOCASCULAR GRAFT WITH H + L-B ONE-SHOT INTRODUCTION SYSTEM (P020018/S019)Cook, Inc.2006-12-06
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