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Cardiovascular

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

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RecordFirmDate
INVIVE CRT PS, INTUA CRT PS (P030005/S109)Guidant Corp.2014-05-28
PUNCTUA ICDS, TELIGEN ICDS, ENERGEN ICDS, INCEPTA ICDS, ORIGEN ICDS, INOGEN ICDS, DYNAGEN ICDS (P960040/S314)Boston Scientific2014-05-28
GORE VIABAHN ENDOPROSTHESIS (P130006/S003)W. L. Gore & Associates, Inc.2014-05-28
CONSULTA CRT-P, SYNCRA CRT-P (P010015/S240)Medtronic, Inc.2014-05-28
CAPSURE FIX NOVUS LEAD. VITATRON CRYSTALLINE ACTICE FIXATION LEAD (P930039/S108)Medtronic, Inc.2014-05-28
GORE VIABAHN EDOPROSTHESIS (P040037/S063)W. L. Gore & Associates, Inc.2014-05-28
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S094)W. L. Gore & Associates, Inc.2014-05-28
ADVANTIO PACEMAKERS, INGENIO PACEMAKERS, VITALIO PACEMAKERS, FORMIO PACEMAKERS (N970003/S163)Boston Scientific Corp2014-05-28
PUNCTUA CRT-DS,COGNIS CRT-DS,ENERGEN CRT-DS,INCEPTA CRT-D,ORIGEN CRT-DS,DYNAGEN CRT-D (P010012/S353)Boston Scientific Corp2014-05-28
ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS (P910023/S333)ABBOTT MEDICAL2014-05-25
EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD (P980016/S479)Medtronic Cardiac Rhythm Disease Management2014-05-23
CONSULTA CRT-P, SYNCRA CRT-P (P010015/S237)Medtronic, Inc.2014-05-23
REVO MRI IPG (P090013/S138)Medtronic, Inc.2014-05-23
DYNAGEN,INOGEN,ORIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P960040/S315)Boston Scientific2014-05-23
ENDURANTSTENT GRAFT SYSTEM; ENDURANT II STENT GRAFT SYSTEM; ENDURANT II AOTO-UNI-LIAC (AUI) STENT GRAFT SYSTEM (P100021/S037)Medtronic Vascular2014-05-23
CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S335)ABBOTT MEDICAL2014-05-23
INVIVE, INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-PS) (P030005/S110)Guidant Corp.2014-05-23
PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUANDRA FAMILIES OF CRT-D DEVICES (P030054/S267)ABBOTT MEDICAL2014-05-23
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S027)Boston Scientific Corp2014-05-23
WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S041)Boston Scientific Corporation2014-05-23
BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S440)Medtronic Cardiac Rhythm Disease Management2014-05-23
RESOLUTE INTEGRITY RX & OTW ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S040)Medtronic Vascular2014-05-23
BRAVA,CONCERTO II, MAXIMO II PRTECTA CRT-D,CONCERTO CONSULTA,INSYNC II PROTECT, INSYNC III MARQUIS , INSYNC MAXIMOICD (P010031/S438)Medtronic Cardiac Rhythm Disease Management2014-05-23
INGENIO,ADVANTIO,VITALIO,FORMIO IMPLANTABLE PULSE GENERATORS (N970003/S164)Boston Scientific Corp2014-05-23
INTEGRITY RX & OTW CORONARY STENT SYSTEMS (P030009/S078)Medtronic, Ireland2014-05-23
WALLSTENT TIPS ENDOPROSTHESIS (P930031/S052)Boston Scientific Corp2014-05-23
ADAPTA,VERSA,SENSIA,IPG,ADVISA DR IPG,ADVISA DR MRI IPG,ENPULSE E1 IPG, ENPULSE E2 IPG,KAPPA D (KAPPA 700)IPG,KAPPA D (P980035/S372)Medtronic, Inc.2014-05-23
DYNAGEN,INOGEN,ORIGEN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) (P010012/S354)Boston Scientific Corp2014-05-23
WALLSTENT ILIAC ENDOPROSTHESIS (P940019/S044)Boston Scientific Scimed, Inc.2014-05-23
MYCARELINK PATIENT MONITOR (P890003/S306)Medtronic, Inc.2014-05-23
EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD,INTRINSIC 30 ICD,INTRINSIC ICD,MARQUIS DR ICD,MARQUIS (P980016/S477)Medtronic Cardiac Rhythm Disease Management2014-05-23
MITRACLIP CLIP DELIVERY SYSTEM (P100009/S005)ABBOTT MEDICAL2014-05-22
ION PACLITAXEL-ELUTING PLATNIUM CHROMIUM CORONARY STENT SYSTEM (P100023/S097)Boston Scientific Corp2014-05-22
MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S482)Medtronic Cardiac Rhythm Disease Management2014-05-22
PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS (P110010/S084)Boston Scientific Corp2014-05-22
CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S444)Medtronic Cardiac Rhythm Disease Management2014-05-22
EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S046)Edwards Lifesciences, LLC2014-05-20
FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S045)Medtronic, Inc.2014-05-19
CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROTHESIS (P870056/S067)Edwards Lifesciences, LLC2014-05-19
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOP (P860057/S121)Edwards Lifesciences, LLC2014-05-19
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LO (P870077/S061)Edwards Lifesciences, LLC2014-05-19
HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S041)Medtronic Heart Valves2014-05-19
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S080)Boston Scientific Corp2014-05-19
HANCOCK II PORCINE BIOPROSTHESIS (P980043/S045)Medtronic, Inc.2014-05-19
COOL POINT(TM) TUBING SET (P060019/S025)Irvine Biomedical, Inc.2014-05-19
QUADRA ASSURA, UNIFY, UNIFY ASSURA, AND UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S266)ABBOTT MEDICAL2014-05-19
CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROTHESIS (P010041/S050)Edwards Lifesciences, LLC2014-05-19
FORTIFY AND FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S334)ABBOTT MEDICAL2014-05-19
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S037)Edwards Lifesciences, LLC2014-05-19
HANCOCK LOW POROSITY VALVED CONDUIT (P870078/S025)Medtronic, Inc.2014-05-19
LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S049)Zoll Manufacturing Corporation2014-05-19
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S050)Edwards Lifesciences, LLC2014-05-19
MOSAIC PORCINE BIOPROSTHESIS (P990064/S054)Medtronic, Inc.2014-05-19
EN TRUST, VIRTUSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, SECURA, VIRTUOSO II, INSYNC MARQUIS, PROTECTA DR,XT, DR, PROT (P980016/S472)Medtronic Cardiac Rhythm Disease Management2014-05-16
BARD ABLATION SYSTEM (P000020/S018)Boston Scientific Corp2014-05-16
RF MARINR MC/SC /SCXL/ SCXS/SCXXL/, RF CONTACTR, RF CONDUCTR & RF CONDUCTR II CARDIAC ABLATION CATHETERS. (P930029/S043)Medtronic, Inc.2014-05-16
CONSULTA CRT-P, SYNCRA CRT-P (P010015/S236)Medtronic, Inc.2014-05-16
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S040)Edwards Lifesciences, LLC2014-05-16
MAXIMO II CRT-D, CONCERTO, CONCERTO II CRT-D, CONSULTA, INSYNC II & IIIMARQUIS, MAXIMO, SENTRY, MARQUIS INSYNC II PROTEC (P010031/S433)Medtronic Cardiac Rhythm Disease Management2014-05-16
ADVISA, ENRHYTHRM MRI (P980035/S369)Medtronic, Inc.2014-05-16
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S053)Edwards Lifesciences, LLC2014-05-16
REVEAL DX. REVEAL XT, REVEAL LINQ INSERTABLE CARDIAC MONITOR (P890003/S305)Medtronic, Inc.2014-05-16
REVO MRI (P090013/S136)Medtronic, Inc.2014-05-16
ADVANTIO, INGENIO PG FAMILIES (N970003/S160)Boston Scientific Corp2014-05-15
ATTAIN ABILITY MODEL 4X96 LEAD (P080006/S063)Medtronic, Inc.2014-05-15
INVIVE CRT-P FAMILY (P030005/S107)Guidant Corp.2014-05-15
ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S375)Medtronic, Inc.2014-05-15
COGNIS CRT-D FAMILY (P010012/S349)Boston Scientific Corp2014-05-15
TELIGEN,INCEPTA,PUNCTUA,ENERGEN ICDS, INCEPTA, PUNCTUA,ENERGEN CRT-DS (P960040/S312)Boston Scientific2014-05-15
REVO MRI IPG (P090013/S140)Medtronic, Inc.2014-05-15
ENDURANT AND ENDURANT II STENT GRAFT SYSTEM (P100021/S036)Medtronic Vascular2014-05-14
CRYOCONSOLE (P020045/S053)Medtronic Cryocath, LP2014-05-14
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S025)Boston Scientific Corp2014-05-14
EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S474)Medtronic Cardiac Rhythm Disease Management2014-05-13
MULTI-LINK ULTRA CORONARY STENT SYSTEMS, MULTI-LINK ZETA CORONARY STENT SYSTEM (P970020/S080)Abbott Vascular, Inc.2014-05-13
BRAVA CRT-D,VIVA S CRT-D, VIVA XT CRT-D (P010031/S435)Medtronic Cardiac Rhythm Disease Management2014-05-13
XIENCE PRIME/XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S067)Abbott Vascular2014-05-13
MULTI-LINK VISION CORONARY STENT SYSTEMS, MULTI-LINK MINI VISION CORONARY STENT SYSTEMS, MULTI-LINK 8 CONONARY STENT (P020047/S058)Abbott Vascular2014-05-13
ENDURANT AND ENDURANT II STENT GRAFT SYSTEM (P100021/S035)Medtronic Vascular2014-05-13
CARPENTIER-EDWARDS PERIMOUNT PERICARDFIAL AORTIC BIOPROSTHESIS (P860057/S124)Edwards Lifesciences, LLC2014-05-13
OMNILINK ELITE VACULAR SYSTEM (P110043/S006)Abbott Vascular-Cardiac Therapies2014-05-13
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S123)Abbott Vascular, Inc.2014-05-13
NIRXCELL COCR CORONARY SENT ON RX (P110004/S003)Medinol, Ltd.2014-05-12
INVIVE AND INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-P) (P010012/S351)Boston Scientific Corp2014-05-12
ADVANTIO, INGENIO, VITALIO AND FORMIO IMPLANTABLE PULSE GENERATOR (PG) (N970003/S162)Boston Scientific Corp2014-05-12
CORDIS SMART CONTROL NITINOL STENT SYSTEM (P020036/S028)Cordis US Corporation2014-05-12
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S082)Boston Scientific Corp2014-05-12
CORDIS SMART CONTROL VASCULAR STENT SYSTEMS (P120002/S003)Cordis US Corporation2014-05-12
THE MYNX VASCULAR CLOSURE DEVICE PRODCUT FAMILY (P040044/S055)Cordis US Corporation2014-05-08
TRIFECTA VALVE (P100029/S015)ABBOTT MEDICAL2014-05-08
THINLINE AND FINELINE TRANSVENOUS ENDOCARDIAL PACING LEADS (P960004/S065)Boston Scientific2014-05-07
VENTAK P2 AICD SYSTEM (P930035/S026)Boston Scientific2014-05-07
AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM (P830060/S079)Boston Scientific2014-05-07
CARDIOGENESIS TMR SYSTEM (P970029/S026)Cryolife, Inc.2014-05-07
VIGOR DR PACEMAKER SYSTEM/VIGOR SR PACEMAKER SYSTEM (P940031/S077)Boston Scientific2014-05-07
VENTAK PRX AICD SYSTEM. PRESCRIPTOR PROGRAMMER AND PROGRAM AND PROGRAM DISK (P910077/S142)Boston Scientific2014-05-07
FLEXTEND PACING LEADS AND FIXATION TOOL (P960006/S042)Boston Scientific2014-05-07
RES-Q ACD (ARRHYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTMY LEAD (NTL) SYSTEMS (P940008/S031)Boston Scientific2014-05-07
CONTAK CD CRT-D &EASYTRAK CORONARY VENOUS STEROID ELUTING SINGLE ELCTRODE PACE/SENSE LEAD (P010012/S352)Boston Scientific Corp2014-05-07
ENDOTAK TRANSVENOUS DEFIBRILLATION SYSTEM (P910073/S125)Boston Scientific2014-05-07
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Every clearance here is in the API, with alerts when new ones post.