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Cardiovascular

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

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RecordFirmDate
FIRE STAR RX PTCA BALLOON DILATATION CATHETER (P880003/S097)Cordis Corp.2009-11-05
VARIOUS FAMILIES OF ICDS (P980016/S144)Medtronic Cardiac Rhythm Disease Management2009-11-05
INSYNC CRT-D, CONCERTO & VARIOUS INSYNC FAMILIES OF ICDS (P010031/S107)Medtronic Cardiac Rhythm Disease Management2009-11-05
PRODIGY/THERA I IPG (P890003/S143)Medtronic, Inc.2009-11-05
KAPPA 400 DR/SR IPG (P970012/S036)Medtronic, Inc.2009-11-05
SPECTRANETICS LASER SHEATH (SLS) (P960042/S012)Spectranetics (Philips)2009-11-05
CAPSURE FIX LEADS (P980016/S210)Medtronic Cardiac Rhythm Disease Management2009-11-05
TLC-II PLUS PORTABLE VAD DRIVER (P870072/S042)Thoratec Laboratories Corp.2009-11-05
HANCOCK II PORCINE BIOPROSTHESIS (P980043/S022)Medtronic, Inc.2009-11-03
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S057)Edwards Lifesciences, LLC2009-11-03
HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT, MODELS 105 AND 150 (P790007/S023)Medtronic Heart Valves2009-11-03
MOSAIC PORCINE BIOPRSTHESIS (P990064/S029)Medtronic, Inc.2009-11-03
FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S026)Medtronic, Inc.2009-11-03
PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM (P960043/S068)Abbott Vascular, Inc.2009-11-03
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S069)Cordis Corp.2009-10-30
SPRINT FIDELIS & QUATTRO (P920015/S040)Medtronic, Inc.2009-10-30
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (P910077/S096)Boston Scientific2009-10-30
CAPSURE SENSE & SP NOVUS (P830061/S040)Medtronic Cardiac Rhythm Disease Management2009-10-30
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S006)Spectranetics Corp.2009-10-30
CAPSURE SP NOVUS & CAPSURE Z NOVUS (P850089/S057)Medtronic Cardiac Rhythm Disease Management2009-10-30
CAPSURE FIX NOVUS & SUREFIX & CAPSURE FIX (P930039/S025)Medtronic, Inc.2009-10-30
CONSULTA/CONCERTO II/MAXIMO II CRT-DS (P010031/S168)Medtronic Cardiac Rhythm Disease Management2009-10-30
SECURA/VIRTUOSO II/MAXIMO II ICDS (P980016/S207)Medtronic Cardiac Rhythm Disease Management2009-10-30
CAPSURE EPI (P950024/S009)Medtronic, Inc.2009-10-30
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S042)Medtronic, Inc.2009-10-30
PALMAZ BALLOON-EXPANDABLE STENT (P890017/S015)Cordis US Corporation2009-10-30
ENDEAVOR AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S040)Medtronic, Inc.2009-10-29
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S061)ABBOTT MEDICAL2009-10-28
LEAD FIXATION SLEEVE (P070008/S013)Biotronik, Inc.2009-10-28
TELIGEN ICDS (P960040/S205)Boston Scientific2009-10-28
COGNIS CRT-DS (P010012/S220)Boston Scientific Corp2009-10-28
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S180)ABBOTT MEDICAL2009-10-28
SYMPHONY SR/DR, RHAPSODY SR/DR, REPLY SR/DR, AND ESPRIT SR/DR PACEMAKERS (P950029/S047)MicroPort CRM USA, Inc.2009-10-28
CONCERTO II CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D (P010031/S156)Medtronic Cardiac Rhythm Disease Management2009-10-27
PARADYM MODEL 8750 CRT-D WITH SMARTVIEW 2.16 UG2 PROGRAMMER SOFTWARE (P060027/S011)MicroPort CRM USA, Inc.2009-10-27
VIRTUOSO II DR/VR/SECURA DR/VR/MAXIMO II DR/VR (P980016/S195)Medtronic Cardiac Rhythm Disease Management2009-10-27
TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT HYDRO DELIVERY SYSTEM (P070027/S012)Medtronic Vascular2009-10-23
ANEURX AAADVANTAGE STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM (P990020/S037)Medtronic Vascular2009-10-23
TALENT THORACIC STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM (P070007/S012)Medtronic Vascular2009-10-23
CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S220)ABBOTT MEDICAL2009-10-22
HOME MONITORING SERVICE CENTER 3 - VERSION 3.6 (P070008/S012)Biotronik, Inc.2009-10-22
HOME MONITORING SERVICE CENTER 3 - VERSION 3.6 (P050023/S026)Biotronik, Inc.2009-10-22
HOME MONITORING SERVICE CENTER 3 - VERSION 3.6 (P950037/S073)Biotronik, Inc.2009-10-22
HOME MONITORING SERVICE CENTER 3 - VERSION 3.6 (P000009/S036)Biotronik, Inc.2009-10-22
COGNIS/LIVIAN/CONTAK RENEWAL/CONTAK RENEWAL 3 RF (P010012/S219)Boston Scientific Corp2009-10-21
PERCLOSE PROGLIDE SUTURE MEDIATED SYSTEM/PERCLOSE A T 6F SUTURE MEDIATED CLOSURE SYSTEM (P960043/S067)Abbott Vascular, Inc.2009-10-21
TELIGEN/CONFIENT/VITALITY PULSE GENERATORS (P960040/S204)Boston Scientific2009-10-21
XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S025)Abbott Vascular, Inc.2009-10-21
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S026)Abbott Vascular, Inc.2009-10-21
CARDIOGENESIS TMR SYSTEM (P970029/S015)Cryolife, Inc.2009-10-20
ENDEAVOR AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S038)Medtronic, Inc.2009-10-19
ON-X PROSTHETIC HEART VALVE (P000037/S016)On-X Life Technologies, Inc.2009-10-16
MYNX VASCULAR CLOSURE DEVICE (P040044/S019)Cordis US Corporation2009-10-16
CADENCE ICDS (P910023/S218)ABBOTT MEDICAL2009-10-14
EPIC HF CRT-DS (P030054/S136)ABBOTT MEDICAL2009-10-14
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S024)Abbott Vascular, Inc.2009-10-14
CYPHER SIROLIMUS-ELUTING STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S068)Cordis Corp.2009-10-09
INSYNC CRT-P/INSYNC III CRT-P (P010015/S072)Medtronic, Inc.2009-10-08
KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S142)Medtronic, Inc.2009-10-08
ADAPTA/VERSA/SENSIA IPG FAMILY/RELIA IPG (P980035/S141)Medtronic, Inc.2009-10-08
KAPPA 400 DR/SR IPG (P970012/S057)Medtronic, Inc.2009-10-08
ANGIOSCULPT SCORING BALLOON CATHETER (P050018/S008)Spectranetics Corp.2009-10-08
MAXIMO II CRT-D/CONSULTA CRT-D/CONCERTO II CRT-D (P010031/S164)Medtronic Cardiac Rhythm Disease Management2009-10-08
CLARITY DDDR, CLARITY SSIR, DIAMOND III, RUBY III, TOPAZ III, JADE III, VITA 2 DDDR, C-SERIES, AND T-SERIES FAMILY OF IP (P990001/S056)Medtronic, Inc.2009-10-08
ADAPTA/VERSA/SENSIA (P980035/S143)Medtronic, Inc.2009-10-08
MARQUIS/MAXIMO/INSTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS (P980016/S204)Medtronic Cardiac Rhythm Disease Management2009-10-08
STARCLOSURE SE VASCULAR CLOSURE SYSTEM (P050007/S022)Abbott Vascular Devices2009-10-08
INSYNC/INSYNC MARQUIS II/III/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO/CONCERTO/II CRT-D/MAXIMO II/CONSULTA CRT-D (P010031/S165)Medtronic Cardiac Rhythm Disease Management2009-10-08
MEDTRONIC MODEL 2490C CARELINK MONITORS (P890003/S174)Medtronic, Inc.2009-10-08
PROCOL VASCULAR BIOPROSTHESIS (P020049/S001)LeMaitre Vascular, Inc.2009-10-08
MAXIMO II ICD/SECURA ICD/VIRTUOSO II ICD (P980016/S203)Medtronic Cardiac Rhythm Disease Management2009-10-08
EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S134)ABBOTT MEDICAL2009-10-02
BLAZER PRIME HTD CARDIAC ABLATION CATHETERS (P920047/S039)Boston Scientific Corp2009-10-02
CADENCE FAMILY OF ICDS (P910023/S217)ABBOTT MEDICAL2009-10-02
SJM BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES (P040021/S011)ABBOTT MEDICAL2009-10-02
BLAZER PRIME XP CARDIAC ABLATION CATHETERS (P020025/S020)Boston Scientific2009-10-02
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S001)Abbott Vascular, Inc.2009-10-01
AMPLATZER SEPTAL OCCLUDER (P000039/S032)ABBOTT MEDICAL2009-10-01
INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO/INSYNC MARQUIS ICDS (P010031/S144)Medtronic Cardiac Rhythm Disease Management2009-10-01
OPTISENSE RIGHT ATRIAL LEAD (P960013/S038)ABBOTT MEDICAL2009-10-01
ENRHYTHM IPG (P980035/S129)Medtronic, Inc.2009-10-01
MARQUIS DR/VR/MAXIMO DR/VR/INTRINSIC ICDS (P980016/S180)Medtronic Cardiac Rhythm Disease Management2009-10-01
BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S004)Bard Peripheral Vascular, Inc.2009-10-01
TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S019)Boston Scientific Corp2009-09-30
LIVEWIRE TC & SAFIRE CARDIAC ABLATION SYSTEMS (P960016/S024)St Jude Medical2009-09-30
FLEXTOME CUTTING BALLOON OTW PTCA CATHETER (P950020/S034)Boston Scientific Corp2009-09-30
QUANTUM MAVERICK PTCA CATHETER/MAVERICK OTW PTCA CATHETER (P860019/S240)Scimed Life Systems, Inc.2009-09-30
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S064)Boston Scientific Corp2009-09-30
EXPRESS2 CORONARY STENT SYSTEM (P020009/S050)Boston Scientific Scimed, Inc.2009-09-30
LIBERTE' CORONARY STENT SYSTEM (P040016/S036)Boston Scientific Scimed, Inc.2009-09-30
MOSAIC PORCINE BIOPROSTHESIS (P990064/S028)Medtronic, Inc.2009-09-29
DURATA, RIATA, RIATA ST, AND RIATA ST OPTIM FAMILY OF LEADS (P950022/S063)ABBOTT MEDICAL2009-09-29
HANCOCK II BIOPROSTHESIS (P980043/S021)Medtronic, Inc.2009-09-29
CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S001)Boston Scientific Corp2009-09-25
TENDRIL/TENDRIL ST & OPTISENSE FAMILIES OF LEADS (P960013/S051)ABBOTT MEDICAL2009-09-25
ADAPTA, VERSA, SENSIA AND RELIA IPG FAMILIES (P980035/S140)Medtronic, Inc.2009-09-25
RIATA/RIATA ST & DURATA FAMILIES OF LEADS (P950022/S064)ABBOTT MEDICAL2009-09-25
QUICKSITE/QUICKFLEX FAMILIES OF LEADS (P030054/S132)ABBOTT MEDICAL2009-09-25
VERIFLEX FOR LIBERTE BARE METAL STENTS (P040016/S037)Boston Scientific Scimed, Inc.2009-09-25
AESCULA FAMILY OF LEFT HEART LEADS (P030035/S058)ABBOTT MEDICAL2009-09-25
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