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Cardiovascular

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

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RecordFirmDate
TELIGEN (P960040/S213)Boston Scientific2010-03-12
OVATIO VR 6250 & OVATIO DR 6550 (P980049/S054)MicroPort CRM USA, Inc.2010-03-12
NAVISTAR THERMOCOOL (P040036/S020)Biosense Webster, Inc.2010-03-12
LINOX SD & LINOX S (P980023/S039)Biotronik, Inc.2010-03-12
OVATIO CRT 6750 (P060027/S021)MicroPort CRM USA, Inc.2010-03-12
NAVISTAR/EZ STEER NAV/QWIKSTAR (P990025/S024)Biosense Webster, Inc.2010-03-12
ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/SECURA/VIRTUOSO/VIRTUOSO II ICDS (P980016/S225)Medtronic Cardiac Rhythm Disease Management2010-03-05
EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003)Boston Scientific Corporation2010-03-05
INSYNC II PROTECT/SENTRY/MARQUIS/MAXIMO ICDS/CONCERTO/CONSULTA/MAXIMO II/CONCERTO II CRT-DS (P010031/S185)Medtronic Cardiac Rhythm Disease Management2010-03-05
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000, 7000TFX AND MODELS 7200TFX (P860057/S065)Edwards Lifesciences, LLC2010-03-05
MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO ICDS/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR (P980016/S226)Medtronic Cardiac Rhythm Disease Management2010-03-05
CADENCE FAMILY OF ICDS (P910023/S230)ABBOTT MEDICAL2010-03-05
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S185)ABBOTT MEDICAL2010-03-05
LUMAX FAMILIES OF ICDS & CRT-DS (P050023/S027)Biotronik, Inc.2010-03-05
CONCERTO/II/CONSULTA/INSYNC II/III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO II CRT-DS (P010031/S184)Medtronic Cardiac Rhythm Disease Management2010-03-05
EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S145)ABBOTT MEDICAL2010-03-05
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S066)ABBOTT MEDICAL2010-03-05
NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/ EZ STEER THERMOCOOL NAV (P040036/S019)Biosense Webster, Inc.2010-03-04
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S032)Abbott Vascular, Inc.2010-03-04
NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/ EZ STEER THERMOCOOL NAV (P030031/S026)Biosense Webster, Inc.2010-03-04
NAVISTAR/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR (P990025/S023)Biosense Webster, Inc.2010-03-04
VIGOR FAMILY (P940031/S066)Boston Scientific2010-03-04
RENEWAL 3 RF/LIVIAN/COGNIS (P010012/S235)Boston Scientific Corp2010-03-04
VENTAK FAMILY (P960040/S217)Boston Scientific2010-03-04
PARADYM CRT-D (P060027/S020)MicroPort CRM USA, Inc.2010-03-04
TELIGEN/CONFIENT (P960040/S215)Boston Scientific2010-03-04
CONTAK RENEWAL TR FAMILY (P030005/S061)Guidant Corp.2010-03-04
NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS (P010068/S019)Biosense Webster, Inc.2010-03-04
CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S224)ABBOTT MEDICAL2010-03-03
CADENCE ICD SYSTEM (P910023/S223)ABBOTT MEDICAL2010-03-03
EPIC HF CRT-D SYSTEM (P030054/S139)ABBOTT MEDICAL2010-03-03
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S007)Boston Scientific Corp2010-03-01
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S043)Boston Scientific Corp2010-03-01
EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S060)Boston Scientific Scimed, Inc.2010-03-01
VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S053)Boston Scientific Scimed, Inc.2010-03-01
PTCA CATHETERS (P860019/S250)Scimed Life Systems, Inc.2010-03-01
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S083)Boston Scientific Corp2010-03-01
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S048)Medtronic, Inc.2010-02-26
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S051)Boston Scientific Scimed, Inc.2010-02-25
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S041)Boston Scientific Corp2010-02-25
FLEXTOME CUTTING BALLOON (P950020/S037)Boston Scientific Corp2010-02-25
MAVERICK2 PTCA CATHETER/APEX PTCA CATHETER (P860019/S248)Scimed Life Systems, Inc.2010-02-25
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROTHESIS MODELS 2700/TFX/2800/TFX/3000/TFX/3300TFX/6900/P/PTFX/7000/TFX (P860057/S067)Edwards Lifesciences, LLC2010-02-24
CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS MODELS 2625/6625 (P870056/S039)Edwards Lifesciences, LLC2010-02-24
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650 (P010041/S024)Edwards Lifesciences, LLC2010-02-24
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS MODELS 6625LP/6625-ESR-LP (P870077/S036)Edwards Lifesciences, LLC2010-02-24
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P030025/S082)Boston Scientific Corp2010-02-22
WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S016)Boston Scientific Corporation2010-02-22
BLAZER PRIME/BLAZER II/BLAZER XP/BLAZER HTD TEMPERATURE ABLATION CATHETERS (P920047/S041)Boston Scientific Corp2010-02-22
EPT-1000 XP CARDIAC ABLATION SYSTEM CONTROLLER AND ACCESSORIES AND MAESTRO 3000 CARDIAC ABLATION SYSTEM AND ACCESSORIES (P020025/S022)Boston Scientific2010-02-22
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S050)Boston Scientific Scimed, Inc.2010-02-22
WALLSTENT LLIAC ENDOPROSTHESIS (P940019/S022)Boston Scientific Scimed, Inc.2010-02-22
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S042)Boston Scientific Corp2010-02-22
VIRTUOSO ICD (P980016/S224)Medtronic Cardiac Rhythm Disease Management2010-02-22
WALLSTENT TIPS ENDOPROSTHESIS (P930031/S027)Boston Scientific Corp2010-02-22
CHILI/CHILI II COOLED ABLATION SYSTEM AND CATHETER (P980003/S022)Boston Scientific Corp2010-02-22
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S040)Boston Scientific Corp2010-02-22
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S005)Boston Scientific Corp2010-02-22
PTCA CATHETERS (P860019/S249)Scimed Life Systems, Inc.2010-02-22
FLEXTOME CUTTING BALLOON DILATATIONS DEVICE (P950020/S038)Boston Scientific Corp2010-02-22
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S003)Boston Scientific Corp2010-02-22
VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S052)Boston Scientific Scimed, Inc.2010-02-22
CONCERTO CRT-D (P010031/S183)Medtronic Cardiac Rhythm Disease Management2010-02-22
ROTABLATOR ATHERECTOMY DEVICES (P900056/S097)Boston Scientific Corp2010-02-22
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S061)Terumo Medical Corporation2010-02-22
EXPRESS2 CORONARY STENT SYSTEMS (P020009/S058)Boston Scientific Scimed, Inc.2010-02-22
EXPRESS2 CORONARY STENT SYSTEM (P020009/S059)Boston Scientific Scimed, Inc.2010-02-22
KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S157)Medtronic, Inc.2010-02-19
INSYNC/INSYNC MARQUIS/II/III/INSYNC II PROTECT/III/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/II/MAXIMO/CONSULTA CRT-DS (P010031/S182)Medtronic Cardiac Rhythm Disease Management2010-02-19
GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS (P980016/S223)Medtronic Cardiac Rhythm Disease Management2010-02-19
INSYNC CRT-P/INSYNC III CRT-P (P010015/S078)Medtronic, Inc.2010-02-19
PRODIGY/THERA I IPG (P890003/S185)Medtronic, Inc.2010-02-19
KAPPA 400 DR/SR IPG (P970012/S063)Medtronic, Inc.2010-02-19
EPICARDIAL PATCH LEAD & SIZING/UPSIZING SLEEVE (P900061/S086)Medtronic Cardiac Rhythm Disease Management2010-02-18
INSYNC ICD/MARQUIS/II MARQUIS/III MARQUIS/II PROTECT/III PROTECT/SENTRY/MAXIMOICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS (P010031/S180)Medtronic Cardiac Rhythm Disease Management2010-02-18
CAPSUREFIX LEAD/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO FAMILY OF ICDS (P980016/S222)Medtronic Cardiac Rhythm Disease Management2010-02-18
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES MODELS 2700/2700TFX/2800/2800TFX/3000/3000TFX/3300TFX/6900P/PTFX (P860057/S066)Edwards Lifesciences, LLC2010-02-18
MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR (P980016/S220)Medtronic Cardiac Rhythm Disease Management2010-02-18
CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS MODELS 6625L/6625-ESR-LP (P870077/S035)Edwards Lifesciences, LLC2010-02-18
CAPSURE SP NOVUS LEADS/CAPSURE LEADS/CAPSURE SP LEADS/CAPSURE SENSE/EXCELLENCE PS +/EXCELLENCE + (P830061/S049)Medtronic Cardiac Rhythm Disease Management2010-02-18
KAPPA 400 DR/SR IPG (P970012/S062)Medtronic, Inc.2010-02-18
ATTAIN OTW/ATTAIN LV LEAD/ATTAIN CS LEAD (P010015/S077)Medtronic, Inc.2010-02-18
ATTAIN SD LH LEAD/INSYNC SENTRY/INSYNC MAXIMO (P010031/S181)Medtronic Cardiac Rhythm Disease Management2010-02-18
CSS-SVC TRANSVENE LEAD (P980050/S046)Medtronic, Inc.2010-02-18
DEMA IPG/C-SERIES IPG/T-SERIES IPG (P990001/S060)Medtronic, Inc.2010-02-18
SELECTSECURE LEAD (P030036/S015)Medtronic Cardiac Rhythm Disease Management2010-02-18
SUREFIX LEAD/CAPSUREFIX LEAD/CAPSUREFIX NOVUS/PIROUET (P930039/S035)Medtronic, Inc.2010-02-18
CAPSURE VDD LEADS/VITATRON LEGACY DR/D/II/VISA/CAPSURE LEAD/BRILLIANT S+VDD (P890003/S184)Medtronic, Inc.2010-02-18
KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S156)Medtronic, Inc.2010-02-18
CARPENTIER EDWARDS PORCINE BIOPROSTHESIS MODELS 2625/6625 (P870056/S038)Edwards Lifesciences, LLC2010-02-18
INSYNC CRT-P/INSYNC III CRT-P (P010015/S076)Medtronic, Inc.2010-02-18
ATTAIN STARFIX LEAD (P060039/S009)Medtronic, Inc.2010-02-18
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S024)Edwards Lifesciences, LLC2010-02-18
PRODIGY/THERA I IPG (P890003/S182)Medtronic, Inc.2010-02-18
CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS MODEL 2650 (P010041/S023)Edwards Lifesciences, LLC2010-02-18
CAPSURE EPI UNIPOLAR & BIPOLAR LEAD (P950024/S019)Medtronic, Inc.2010-02-18
CAPSURE Z/NOVUS LEADS/ CAPSURE SP/NOVUS LEADS/EXCELLENCE S+/IMPULSE/VITATRON IMPULSE II (P850089/S064)Medtronic Cardiac Rhythm Disease Management2010-02-18
SPRINT/SPRINT QUATTRO/SPRINT QUATTRO SECURE LEAD/TRANSVENE SVC/DF-1 LEADS/SPRINT QUATTRO SINGLE COIL/END CAP ACCESSORY (P920015/S058)Medtronic, Inc.2010-02-18
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S034)W. L. Gore & Associates, Inc.2010-02-12
FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S028)Medtronic, Inc.2010-02-05
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