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Cardiovascular

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

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RecordFirmDate
ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S020)Cook, Inc.2006-12-06
FLEXTOME CUTTING BALLOON MONORAIL & OVER-THE-WIRE (P950020/S021)Boston Scientific Corp2006-12-06
CONTAK RENEWAL TR FAMILY (P030005/S040)Guidant Corp.2006-12-06
PRIZM/VITALITY FAMILY (P960040/S136)Boston Scientific2006-12-06
MERIDIAN/DISCOVERY FAMILY (P940031/S060)Boston Scientific2006-12-06
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S016)W. L. Gore & Associates, Inc.2006-12-06
CONTAK RENEWAL FAMILY (P010012/S143)Boston Scientific Corp2006-12-06
TENDRILL SDX LEAD MODELS 1488T/1488TC (P960013/S023)ABBOTT MEDICAL2006-12-05
NAVISTAR THERMOCOOL CATHETER (P040036/S001)Biosense Webster, Inc.2006-12-04
BOSTON SCIENTIFIC XP APM (AUTOMATIC PERSONALITY MODULE) UNIT, MODEL 822T (P920047/S035)Boston Scientific Corp2006-12-01
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S136)ABBOTT MEDICAL2006-11-30
EPIC HF/ATLAS+HF FAMILY OF CRT-DS (P030054/S043)ABBOTT MEDICAL2006-11-30
MICRONY FAMILY OF PACEMAKERS PACEMAKER PROGRAMMER (P970013/S014)ABBOTT MEDICAL2006-11-30
CADENCE FAMILY OF ICDS (P910023/S124)ABBOTT MEDICAL2006-11-30
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S047)St. Jude Medical, Inc.2006-11-30
PARAGON/PHOENIX FAMILY OF PACEMAKERS (P830045/S104)St. Jude Medical, Inc.2006-11-30
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S026)ABBOTT MEDICAL2006-11-30
ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S021)Cook, Inc.2006-11-29
VICTORY PULSE GENERATORS (P880086/S138)ABBOTT MEDICAL2006-11-29
SELECTED FAMILIES OF ICD'S (P980016/S089)Medtronic Cardiac Rhythm Disease Management2006-11-29
MEDTRONIC 2490 A/C/D/E/G/H/J CARELINK MONITORS (P890003/S112)Medtronic, Inc.2006-11-29
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S028)Cordis Corp.2006-11-29
VARIOUS FAMILIES OF ICD'S (P900061/S069)Medtronic Cardiac Rhythm Disease Management2006-11-29
INSYNC FAMILIES OF CRT-ICD'S (P010031/S056)Medtronic Cardiac Rhythm Disease Management2006-11-29
VARIOUS FAMILIES OF PACEMAKERS (P980035/S066)Medtronic, Inc.2006-11-29
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S137)ABBOTT MEDICAL2006-11-21
CADENCE FAMILY ICDS (P910023/S125)ABBOTT MEDICAL2006-11-21
ANGIOJET ULTRA THROMBECTOMY SYSTEM (XMI CATHETER) (P980037/S015)Boston Scientific Corp2006-11-21
XACT CAROTID STENT SYSTEM (P040038/S006)Abbott Vascular, Inc.2006-11-21
DRIVER AND MICRODRIVER CORONARY STENT SYSTEMS (P030009/S007)Medtronic, Ireland2006-11-21
PERCLOSE PROGLIDE 6 FRENCH SUTURE-MEDIATED CLOSURE (SMC) SYSTEMS (P960043/S060)Abbott Vascular, Inc.2006-11-21
MULTI-LINK RX AND OTW VISION AND MINI VISION CORONARY STENT SYSTEMS (P020047/S005)Abbott Vascular2006-11-21
EPIC HF FAMILY CRT-DS (P030054/S044)ABBOTT MEDICAL2006-11-21
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S027)ABBOTT MEDICAL2006-11-21
CADENCE FAMILY ICDS (P910023/S123)ABBOTT MEDICAL2006-11-16
CORDIS PRECISE OTW 5.5 FR AND 6.0 FR NITINOL STENT SYSTEM (P030047/S001)Cordis US Corporation2006-11-16
EPIC HF FAMILY CRT-DS (P030054/S042)ABBOTT MEDICAL2006-11-16
VARIOUS FAMILIES OF PACEMAKERS (P990001/S027)Medtronic, Inc.2006-11-15
INSYNC/INSYNC III CRT-IPGS (P010015/S025)Medtronic, Inc.2006-11-15
MEDTRONIC VIRTUOSO MODEL D154AWG/ D154VWC IMPLANTABLE DEVICES (P980016/S084)Medtronic Cardiac Rhythm Disease Management2006-11-15
VARIOUS FAMILIES OF ICDS (P980016/S087)Medtronic Cardiac Rhythm Disease Management2006-11-15
VARIOUS FAMILIES OF PACEMAKERS AND MEDTRONIC CARELINK MONITOR (MODEL 2490H) (P890003/S110)Medtronic, Inc.2006-11-15
KAPPA, ENPULSE, ADAPTA, SENSIA AND VERSA PACEMAKERS (P980035/S063)Medtronic, Inc.2006-11-15
RIATA FAMILY OF LEADS (P950022/S031)ABBOTT MEDICAL2006-11-15
KAPPA 700, KAPPA 900, ENPULSE, ADAPTA/VERSA/SENSIA, SIGMA, MEDTRONIC 350 SERIES, ENRHYTHM, AT500 (P980035/S064)Medtronic, Inc.2006-11-15
INSYNC II PROTECT, INSYNC III PROTECT, INTRINSIC 30, INTRINSIC, INSYNC SENTRY, INSYNC MAXIMO, CONCERTO (P010031/S054)Medtronic Cardiac Rhythm Disease Management2006-11-15
KAPPA 400 FAMILY OF PACEMAKERS (P970012/S025)Medtronic, Inc.2006-11-15
JEWEL AF, GEM II AT FAMILY OF ICDS (P980050/S025)Medtronic, Inc.2006-11-15
CONCERTO MODELS C154DWK (P010031/S051)Medtronic Cardiac Rhythm Disease Management2006-11-15
INSYNC MARQUIS MODEL 7277LINSYNC II MARQUIS MODEL 7289; INSYNC III MARQUIS MODEL 7279,INSYNC II PROTECT MODEL 7295; UNSY (P010031/S053)Medtronic Cardiac Rhythm Disease Management2006-11-15
MARQUIS DR/VR MODELS 7274,7230B,7230CX,7230E:MAXIMO DR/VR MODELS 7278,7232B,7232CX,7232E INTRINSIC MODELS 7288:ENTRUST D (P980016/S086)Medtronic Cardiac Rhythm Disease Management2006-11-15
GEM FAMILY OF ICDS (P900061/S067)Medtronic Cardiac Rhythm Disease Management2006-11-15
ST. JUDE MEDICAL BIOCOR VALVE AND BIOCOR SUPRA VALVE (P040021/S005)ABBOTT MEDICAL2006-11-14
THERAPY ABLATION CATHETER AND IBI 1500T CARDIAC ABLATION GENERATOR (P040014/S003)Irvine Biomedical, Inc.2006-11-13
CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S023)Cordis Corp.2006-11-09
SOLUS, ADDVENT, SOLUS II, SYNCHRONY, PHOENIX III, TRILOGY, AFFINITY, INTEGRITY, ENTITY, IDENTITY, VERITY AND VICTORY PAC (P880086/S135)ABBOTT MEDICAL2006-11-09
S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S006)Cordis US Corporation2006-11-09
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX (P860057/S040)Edwards Lifesciences, LLC2006-11-08
SPRINT LEADS, TUNNELING TOOLS (P920015/S035)Medtronic, Inc.2006-11-07
INSYNC III, INSYNC, ATTAIN (P010015/S023)Medtronic, Inc.2006-11-07
MEDTRONIC HALL (P790018/S046)Medtronic Cardiac Surgery2006-11-07
CAPSURE EPICARDIAL LEADS (P950024/S008)Medtronic, Inc.2006-11-07
KAPPA 700, VITATRON, KAPPA 900, ENPULSE, SIGMA, MEDTRONIC 350 SERIES, ENRHYTHM, AT500 (P980035/S057)Medtronic, Inc.2006-11-07
KAPPA 400 (P970012/S023)Medtronic, Inc.2006-11-07
VARIOUS FAMILIES OF ICDS (P980016/S074)Medtronic Cardiac Rhythm Disease Management2006-11-07
GEM III AT ICD & TRANSVENE LEAD (P980050/S023)Medtronic, Inc.2006-11-07
VARIOUS MODELS OF INSYNC ICDS (P010031/S041)Medtronic Cardiac Rhythm Disease Management2006-11-07
IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) GEM (P900061/S065)Medtronic Cardiac Rhythm Disease Management2006-11-07
CAPSURE PACING LEADS (P850089/S054)Medtronic Cardiac Rhythm Disease Management2006-11-07
MEDTRONIC SELECTSECURE LEADS (P030036/S001)Medtronic Cardiac Rhythm Disease Management2006-11-07
LEGACY D, LEGACY S, LEGACY II, VISA, CAPSURE PACING LEADS (P890003/S104)Medtronic, Inc.2006-11-07
FLEXTOME CUTTING BALLOON MONORAIL (P950020/S020)Boston Scientific Corp2006-11-05
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S037)Corcym S.r.l.2006-11-03
ANGIOLINK VASCULAR CLOSURE SYSTEM (P040022/S002)Medtronic Vascular2006-11-01
ENDOLOGIX POWERLINK SYSTEM (P040002/S007)Endologix, LLC2006-11-01
LIFEVEST (WCD 3100) DEVICE (P010030/S007)Zoll Manufacturing Corporation2006-11-01
TUPOS LV/ATX & KRONOS LV-T CRT-DS & COROX OTW STEROID LV PACING LEAD (P050023/S002)Biotronik, Inc.2006-10-30
AFFINITY/INTREGITY/VICTORY FAMILY PACEMAKERS (P880086/S134)ABBOTT MEDICAL2006-10-27
FRONTIER/FRONTIER II FAMILY OF CRT-P'S (P030035/S025)ABBOTT MEDICAL2006-10-27
CADENCE FAMILY OF ICDS (P910023/S122)ABBOTT MEDICAL2006-10-27
EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S041)ABBOTT MEDICAL2006-10-27
ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM (P050025)Boston Scientific2006-10-27
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S040)Boston Scientific Corp2006-10-26
ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S017)Cook, Inc.2006-10-25
SENSOLOG/DIALOG/REGENCY FAMILY PACEMAKERS (P880006/S045)St. Jude Medical, Inc.2006-10-25
PARAGON/PHOENIX FAMILY PACEMAKERS (P830045/S102)St. Jude Medical, Inc.2006-10-25
AFFINITY/INTEGRITY/VICTORY FAMILY PACEMAKERS (P880086/S132)ABBOTT MEDICAL2006-10-25
ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S018)Cook, Inc.2006-10-25
FRONTIER/FRONTIER II FAMILY CRT-PS (P030035/S023)ABBOTT MEDICAL2006-10-25
GORE VIATORR TIPS (P040027/S003)W. L. Gore & Associates, Inc.2006-10-25
EPIC HF/ATLAS + HF FAMILY CRT-DS (P030054/S039)ABBOTT MEDICAL2006-10-25
CADENCE FAMILY ICDS (P910023/S120)ABBOTT MEDICAL2006-10-25
MICRONY FAMILY PACEMAKERS (P970013/S012)ABBOTT MEDICAL2006-10-25
CARELINK MONITORS 2490H, AND MODEL 2020A CARDIOSIGHT READER (P890003/S109)Medtronic, Inc.2006-10-20
GEM DR, GEM II DR/VR, GEM III DR/VR, ONYX, MARQUIS DR/VR, MAXIMO DR/VR, INTRINSIC AND INTRINSIC 30 IMPLANTABLE DEVICES (P980016/S085)Medtronic Cardiac Rhythm Disease Management2006-10-20
CADENCE FAMILY OF ICD'S (P910023/S121)ABBOTT MEDICAL2006-10-20
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S024)ABBOTT MEDICAL2006-10-20
PARAGON/PHOENIX FAMILY OF PACEMAKERS (P830045/S103)St. Jude Medical, Inc.2006-10-20
KAPPA 600/700/800/900 AND ENPULSE FAMILIES OF PACEMAKERS (P980035/S062)Medtronic, Inc.2006-10-20
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S133)ABBOTT MEDICAL2006-10-20
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