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Cardiovascular

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

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RecordFirmDate
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S025)W. L. Gore & Associates, Inc.2008-10-03
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S037)W. L. Gore & Associates, Inc.2008-10-03
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM OVER-THE-WIRE (OTW) & RAPID EXCHANGE (RX) & MULTI EXCHANGE II (P060033/S001)Medtronic, Inc.2008-10-02
INSYNC FAMILIES OF ICDS (P010031/S120)Medtronic Cardiac Rhythm Disease Management2008-10-02
VARIOUS FAMILIES OF ICDS (P980016/S152)Medtronic Cardiac Rhythm Disease Management2008-10-02
AFFINITY/INTEGRITY/VICTORY FAMILIES OF PACEMAKERS (P880086/S168)ABBOTT MEDICAL2008-10-01
MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT (P980035/S098)Medtronic, Inc.2008-10-01
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S047)ABBOTT MEDICAL2008-10-01
MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT (P010031/S101)Medtronic Cardiac Rhythm Disease Management2008-10-01
MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT (P980016/S132)Medtronic Cardiac Rhythm Disease Management2008-10-01
CORONARY FLEXTOME CUTTING BALLOON DEVICE (P950020/S030)Boston Scientific Corp2008-10-01
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK EXCHANGEABLE CATHETER (P900056/S093)Boston Scientific Corp2008-09-30
CORDIS PRECISE NITINOL STENT SYSTEM & RX NITINOL STENT & PRO RX NITINOL STENT SYSTEM (P030047/S011)Cordis US Corporation2008-09-30
EZ STEER THERMOCOOL AND EZ STEER THERMOCOOL NAV DIAGNOSTIC/ABLATION CATHETERS (P030031/S009)Biosense Webster, Inc.2008-09-30
DURA STAR RX PTCA BALLOON DILATATION CATHETER (P880003/S095)Cordis Corp.2008-09-30
EZ STEER THERMOCOOL AND (P040036/S006)Biosense Webster, Inc.2008-09-30
FLEXTOME CUTTING BALLOON MONORAIL(MR) AND OVER THE WIRE (OTW) (P950020/S013)Boston Scientific Corp2008-09-29
FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS (P950020/S015)Boston Scientific Corp2008-09-29
FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS (P950020/S014)Boston Scientific Corp2008-09-29
TAXUS EXPRESS2 OTW PACLITAXEL ELUTING STENT SYSTEM (P030025/S058)Boston Scientific Corp2008-09-26
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S052)Terumo Medical Corporation2008-09-26
MAVERICK OTW PTCA CATHETER AND QUANTUM MAVERICK OTW PTCA CATHETER (P860019/S228)Scimed Life Systems, Inc.2008-09-26
VITALITY AND VITALITY 2 (P960040/S176)Boston Scientific2008-09-26
SJM BIOCOR VALVE & SUPRA VALVE (P040021/S007)ABBOTT MEDICAL2008-09-26
LIBERTE OTW CORONARY STENT SYSTEM (P040016/S033)Boston Scientific Scimed, Inc.2008-09-26
EXPRESS2 OTW CORONARY STENT SYSTEM (P020009/S046)Boston Scientific Scimed, Inc.2008-09-26
CONTAK RENEWAL TR (P030005/S054)Guidant Corp.2008-09-26
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY SYSTEMS (P060033/S002)Medtronic, Inc.2008-09-25
DRIVER & MICRODRIVER CORONARY STENT SYSTEMS (P030009/S019)Medtronic, Ireland2008-09-25
GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETERS (P790017/S094)Medtronic, Ireland2008-09-25
TAXUS EXPRESS2 PACLITAXEL CORONARY STENT SYSTEM (P030025/S021)Boston Scientific Corp2008-09-24
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S034)W. L. Gore & Associates, Inc.2008-09-24
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER -THE-WIRE) (P030025/S028)Boston Scientific Corp2008-09-24
FLAIR ENDOVASCULAR STENT GRAFT (P060002/S003)Bard Peripheral Vascular2008-09-23
DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM (P030009/S021)Medtronic, Ireland2008-09-22
STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S012)Abbott Vascular Devices2008-09-19
CHILLI COOLED ABLATION CATHETER (P980003/S021)Boston Scientific Corp2008-09-19
ABIOMED ARTERIAL CANNULA (P900023/S050)Abiomed Cardiovascular, Inc.2008-09-18
DURATA, RIATA ST OPTIM, RIATA ST, RIATA 8F (P950022/S052)ABBOTT MEDICAL2008-09-18
VARIOUS FAMILIES OF PACEMAKERS (P980035/S112)Medtronic, Inc.2008-09-17
CONCERTO/MAXIMO II/CONSULTA (P010031/S118)Medtronic Cardiac Rhythm Disease Management2008-09-17
VARIOUS FAMILIES OF ICDS (P980016/S149)Medtronic Cardiac Rhythm Disease Management2008-09-17
VARIOUS FAMILIES OF PACEMAKERS (P990001/S043)Medtronic, Inc.2008-09-17
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S013)Medtronic, Inc.2008-09-16
SUTURE MEDIATED CLOSURE (SMC) SYSTEMS (P960043/S064)Abbott Vascular, Inc.2008-09-12
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S057)Cordis Corp.2008-09-12
STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S011)Abbott Vascular Devices2008-09-12
SJM MASTER HP VALVED GRAFT WITH GELWEAVE VALSALVA (P810002/S063)ABBOTT MEDICAL2008-09-12
NC STORMER BALLOON DILATATION CATHETERS (P790017/S097)Medtronic, Ireland2008-09-11
SOLARGEN 2100S LASER (P970029/S012)Cryolife, Inc.2008-09-11
DRIVER AND MICRODRIVER CORONARY STENT SYSTEMS (P030009/S023)Medtronic, Ireland2008-09-11
DRIVER & MICRO-DRIVER CORONARY STENT SYSTEM (P030009/S026)Medtronic, Ireland2008-09-11
VARIOUS FAMILIES OF PACEMAKERS (P980035/S111)Medtronic, Inc.2008-09-11
ANEURX STENT GRAFT SYSTEM (P990020/S032)Medtronic Vascular2008-09-11
ATS MECHANICAL HEART VALVES (P990046/S018)Medtronic Ats Medical, Inc.2008-09-11
KAPPA 400 SR (P970012/S042)Medtronic, Inc.2008-09-11
VARIOUS FAMILIES OF PACEMAKERS (P980035/S110)Medtronic, Inc.2008-09-10
EPIC HF (P030054/S102)ABBOTT MEDICAL2008-09-10
KAPPA 400 DR/SR (P970012/S041)Medtronic, Inc.2008-09-10
CADENCE (P910023/S187)ABBOTT MEDICAL2008-09-10
VARIOUS FAMILIES OF ICDS (P980016/S148)Medtronic Cardiac Rhythm Disease Management2008-09-10
PROGRAMMER APPLICATION SOFTWARE PACKAGE VERSION SMARTVIEW 2.02 UG4 FOR ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS (P980049/S037)MicroPort CRM USA, Inc.2008-09-10
CADENCE FAMILY OF ICDS (P910023/S186)ABBOTT MEDICAL2008-09-10
INSYNC CRT-D/CONCERTO/CONSULTA/MAXIMO II & VARIOUS INSYNC FAMILIES OF ICDS (P010031/S117)Medtronic Cardiac Rhythm Disease Management2008-09-10
CORDIS PRECISE NITINOL STENT SYSTEM (P030047/S012)Cordis US Corporation2008-09-10
VARIOUS FAMILIES OF PACEMAKERS (P990001/S042)Medtronic, Inc.2008-09-10
PROMOTE FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P030054/S101)ABBOTT MEDICAL2008-09-10
GEM & GEM II VR (P900061/S078)Medtronic Cardiac Rhythm Disease Management2008-09-10
GEM II AT (P980050/S036)Medtronic, Inc.2008-09-10
OVATIO CRT-D SYSTEM (P060027/S001)MicroPort CRM USA, Inc.2008-09-10
CHORUS PACEMAKERS (P900022/S011)MicroPort CRM USA, Inc.2008-09-10
VARIOUS FAMILIES OF PACEMAKERS (P950029/S036)MicroPort CRM USA, Inc.2008-09-10
INSYNC PULSE GENERATOR; INSYNC III (P010015/S051)Medtronic, Inc.2008-09-10
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S166)ABBOTT MEDICAL2008-09-09
CADENCE FAMILY OF ICDS (P910023/S184)ABBOTT MEDICAL2008-09-09
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S060)St. Jude Medical, Inc.2008-09-09
MICRONY FAMILY OF PACEMAKERS (P970013/S027)ABBOTT MEDICAL2008-09-09
FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S024)Medtronic, Inc.2008-09-09
EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S099)ABBOTT MEDICAL2008-09-09
FRONTIER/FRONTIERII FAMILY OF CRT-PS (P030035/S045)ABBOTT MEDICAL2008-09-09
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S005)Abbott Vascular, Inc.2008-09-09
MEDTRONIC HALL PROSTHETIC HEART VALVE (P790018/S049)Medtronic Cardiac Surgery2008-09-09
XIENCE V RX EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S004)Abbott Vascular, Inc.2008-09-05
LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE MODELS: 6482 AND 6488 (P910077/S091)Boston Scientific2008-09-05
MAXIMO II DR/VR (P980016/S147)Medtronic Cardiac Rhythm Disease Management2008-09-04
EPIC HF / ATLAS + FAMILY OF CRT-DS (P030054/S103)ABBOTT MEDICAL2008-09-04
MAXIMO II CRT-D (P010031/S116)Medtronic Cardiac Rhythm Disease Management2008-09-04
CADENCE FAMILY OF ICDS (P910023/S188)ABBOTT MEDICAL2008-09-04
TALENT THORACIC STENT GRAFT SYSTEM (P070007/S002)Medtronic Vascular2008-09-03
MULTI-LINK VISION OTW FAMILY OF CORONARY STENT SYSTEMS (P020047/S012)Abbott Vascular2008-09-03
MULTI-LINK OTW ZETA CORONARY STENT SYSTEMS (P970020/S052)Abbott Vascular, Inc.2008-09-03
MEDTRONIC SELECTSECURE MODEL 3830 LEAD (P030036/S008)Medtronic Cardiac Rhythm Disease Management2008-08-29
ACUITY STEERABLE FAMILY OF LEADS (P050046/S003)Guidant Corp.2008-08-29
SJM MASTERS SERIES AORTIC VALVED GRAFT (MODEL CAVGJ), AND THE SJM MASTERS HP VALVED GRAFT (MODEL VAVGJ) (P810002/S067)ABBOTT MEDICAL2008-08-29
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX (P860057/S029)Edwards Lifesciences, LLC2008-08-29
EASYTRAK 3 IS-1 & LV-1 (P010012/S190)Boston Scientific Corp2008-08-29
CYPHER SIROLIMUS-ELUTING CORONARY STENTS (P020026/S056)Cordis Corp.2008-08-28
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S003)Abbott Vascular, Inc.2008-08-28
CONTAK RENEWAL 3 RF AND LIVIAN FAMILIES OF CRT-D (P010012/S188)Boston Scientific Corp2008-08-28
VIRTUOSO DR/VR/ENTRUST DR/VR/MAXIMO DR/VR/INTRINSIC DR (P980016/S135)Medtronic Cardiac Rhythm Disease Management2008-08-28
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