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Cardiovascular

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

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RecordFirmDate
COGNIS CRT-DS (P010012/S209)Boston Scientific Corp2009-06-12
THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF ABLATION GENERATOR (P060019/S005)Irvine Biomedical, Inc.2009-06-12
ACCENT/ZEPHYR/ VICTORY PACEMAKERS (P880086/S175)ABBOTT MEDICAL2009-06-12
ANTHEM/FRONTIER II CRT-PS (P030035/S055)ABBOTT MEDICAL2009-06-12
TELIGEN ICDS (P960040/S195)Boston Scientific2009-06-12
ESPRIT MODELS SR AND DR PACEMAKER SYSTEMS WITH THE PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.16 UG1 (P950029/S041)MicroPort CRM USA, Inc.2009-06-11
GORE VIABAHN ENDOPROSTHESIS (P040037/S019)W. L. Gore & Associates, Inc.2009-06-10
RF CONDUCTR ABLATION CATHETERS (P930029/S022)Medtronic, Inc.2009-06-10
ENDOTAK RELIANCE TACHY LEAD (P910073/S078)Boston Scientific2009-06-10
PROMOTE/PROMOTE+ CRT-D (P030054/S125)ABBOTT MEDICAL2009-06-10
CURRENT/CURRENT+ ICD (P910023/S210)ABBOTT MEDICAL2009-06-10
FINELINE II/THINLINE II BRADY LEADS (P960004/S042)Boston Scientific2009-06-05
MODEL 4194 ATTAIN BIPOLAR OVER-THE-WIRE LEAD (P010015/S068)Medtronic, Inc.2009-06-05
IPULSE CIRCULATORY SUPPORT SYSTEM (P900023/S051)Abiomed Cardiovascular, Inc.2009-06-05
TELIGEN ICDS (P960040/S196)Boston Scientific2009-06-03
COGNIS CRT-D (P010012/S210)Boston Scientific Corp2009-06-03
THERAPY ABLATION CATHETERS (P040014/S010)Irvine Biomedical, Inc.2009-06-01
SPECTRANETICS LASER SHEATH (SLS) (P960042/S013)Spectranetics (Philips)2009-06-01
THERAPY COOL PATH ABLATION CATHETERS (P060019/S008)Irvine Biomedical, Inc.2009-06-01
CVX-300 CORONARY LASER CATHETER (P910001/S031)Spectranetics Corp.2009-06-01
THERAPY DUAL 8 ABLATION CATHETERS (P040042/S015)Irvine Biomedical,Inc.(Ibi)2009-06-01
XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S016)Abbott Vascular, Inc.2009-05-29
TELIGEN FAMILY (P960040/S193)Boston Scientific2009-05-26
TENDRIL STS LEAD MODEL 2088TC (P960013/S046)ABBOTT MEDICAL2009-05-26
COGNIS CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR (P010012/S207)Boston Scientific Corp2009-05-26
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S231)Advanced Cardiovascular Systems, Inc.2009-05-26
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P060008/S017)Boston Scientific Corp2009-05-26
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S096)Boston Scientific Corp2009-05-22
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S016)Boston Scientific Corp2009-05-22
LEAD END CAP KIT/ LEAD ADAPTOR SLEEVE KIT/UPSIZING SLEEVE KIT (P900061/S083)Medtronic Cardiac Rhythm Disease Management2009-05-21
TENDRIL FAMILIES OF LEADS (P960013/S044)ABBOTT MEDICAL2009-05-21
PRIZM/VITALITY/CONFIENT FAMILIES (P960040/S194)Boston Scientific2009-05-21
LEGEND PLUS FAMILY OF PACEMAKERS (P930022/S009)Medtronic, Inc.2009-05-21
TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S003)Medtronic Vascular2009-05-21
RENEWAL TR FAMILY (P030005/S057)Guidant Corp.2009-05-21
CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS (P980016/S184)Medtronic Cardiac Rhythm Disease Management2009-05-21
TALENT THORACIC STENT GRAFT SYSTEM (P070007/S003)Medtronic Vascular2009-05-21
KAPPA 400 DR/SR IPG (P970012/S053)Medtronic, Inc.2009-05-21
MEDTRONIC / VITATRON CARELINK PROGRAMMING OPERATING SYSTEM AND MEDICAL DEVICE APPLICATION SOFTWARE (P890003/S168)Medtronic, Inc.2009-05-21
TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S008)Boston Scientific Corp2009-05-21
ZENITH TX2 TAA ENDOVASCULAR GRAFT (P070016/S004)William Cook Europe Aps2009-05-21
DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR (P820003/S091)Medtronic Cardiac Rhythm Disease Management2009-05-21
CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS (P010031/S147)Medtronic Cardiac Rhythm Disease Management2009-05-21
RENEWAL/LIVIAN FAMILIES (P010012/S208)Boston Scientific Corp2009-05-21
KAPPA 600/700/650&800/900 & SIGMA/MEDTRONIC 350/RELIA/ENPULSE II/AT500/ADAPTA/VERSA/SENSIA/ENRHYTHM FAMILIES OF IPG (P980035/S131)Medtronic, Inc.2009-05-21
DEMA FAMILIES/C & T SERIES DEVICES (P990001/S052)Medtronic, Inc.2009-05-21
TRANSVENE CS/SVC LEAD (P980050/S041)Medtronic, Inc.2009-05-21
VARIOUS FAMILIES OF PACEMAKERS (P850051/S070)Medtronic, Inc.2009-05-21
INSYNC III (P010015/S065)Medtronic, Inc.2009-05-21
LIBERTE CORONARY STENT SYSTEM (P040016/S022)Boston Scientific Scimed, Inc.2009-05-15
EXPRESS2 CORONARY STENT SYSTEM (P020009/S036)Boston Scientific Scimed, Inc.2009-05-15
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S044)Boston Scientific Corp2009-05-15
VARIOUS FAMILIES OF PACEMAKERS/ DEFIBRILLATORS/ CRTS (P920015/S054)Medtronic, Inc.2009-05-14
CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATHETERS (P950005/S026)Biosense Webster, Inc.2009-05-13
CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATHETERS (P990025/S018)Biosense Webster, Inc.2009-05-13
CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATHETERS (P010068/S014)Biosense Webster, Inc.2009-05-13
APEX PTCA BALLOON DILATION CATHETER (P860019/S235)Scimed Life Systems, Inc.2009-05-13
LUMAX FAMILY OF ICDS (P050023/S020)Biotronik, Inc.2009-05-12
LUMOS DR-T AND LUMOS VR-T (P000009/S033)Biotronik, Inc.2009-05-12
AMPLATZER SEPTAL OCCLUDER (P000039/S031)ABBOTT MEDICAL2009-05-12
PHILOS II DR-T (P950037/S068)Biotronik, Inc.2009-05-12
MYNX VASCULAR CLOSURE DEVICE (P040044/S014)Cordis US Corporation2009-05-12
STRATOS LV-T (P070008/S009)Biotronik, Inc.2009-05-12
ATS MEDICAL OPEN PIVOT BI-LEAFLET MECHANICAL HEART VALVE (P990046/S021)Medtronic Ats Medical, Inc.2009-05-12
ATTAIN ABILITY LEAD (P080006/S001)Medtronic, Inc.2009-05-08
APEX MONORAIL & OVER-THE-WIRE PTCA CATHETERS (P860019/S236)Scimed Life Systems, Inc.2009-05-08
XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S015)Abbott Vascular, Inc.2009-05-08
OVATIO VR/DR (P980049/S048)MicroPort CRM USA, Inc.2009-05-08
CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II (P010031/S154)Medtronic Cardiac Rhythm Disease Management2009-05-08
CAPSURE VDD LEAD (P890003/S171)Medtronic, Inc.2009-05-08
SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR (P980016/S193)Medtronic Cardiac Rhythm Disease Management2009-05-08
CAPSUREFIX NOVUS LEAD (P930039/S032)Medtronic, Inc.2009-05-08
OVATIO CRT (P060027/S014)MicroPort CRM USA, Inc.2009-05-08
XACT CAROTID STENT SYSTEM (P040038/S018)Abbott Vascular, Inc.2009-05-07
CADENCE FAMILY ICDS (P910023/S206)ABBOTT MEDICAL2009-05-07
TAXUS LIBERTE PACLITAXEL-ELUTING STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P060008/S010)Boston Scientific Corp2009-05-07
RIATA ST OPTIM/DURATA LEADS (P950022/S056)ABBOTT MEDICAL2009-05-07
ATLAS II+ HF CRT-D & PROMOTE HE CRT-D (P030054/S114)ABBOTT MEDICAL2009-05-07
ANGIO-SEAL VASULAR CLOSURE DEVICE (P930038/S058)Terumo Medical Corporation2009-05-07
TAXUS LIBERTE PACLITAXEL-ELUTING STENT SYSTEM (P060008/S015)Boston Scientific Corp2009-05-07
EPIC HF FAMILY CRT-DS (P030054/S122)ABBOTT MEDICAL2009-05-07
SJM MODEL 3510 PROGRAMMER(FOR ATLAS II CRT-D)/MERLIN MODEL 3650 PROGRAMMER( FOR ATLAS II & PROMOTE CRT-D) (P910023/S200)ABBOTT MEDICAL2009-05-07
CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S042)Edwards Lifesciences, LLC2009-05-07
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S063)Cordis Corp.2009-05-06
SJM BIOCOR/BIOCOR SUPRA VALVES (P040021/S008)ABBOTT MEDICAL2009-05-04
SYMPHONY SR/DR/RHAPSODY SR/DR/REPLY VR/DR (P950029/S044)MicroPort CRM USA, Inc.2009-05-01
BIOGLUE SURGICAL ADHESIVE (P010003/S013)Cryolife, Inc.2009-05-01
CARELINK MONITOR (P890003/S154)Medtronic, Inc.2009-05-01
STARCLOSURE SE VASCULAR CLOSURE SYSTEM (P050007/S013)Abbott Vascular Devices2009-05-01
CONCERTO/CONCERTO II CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D (P010031/S132)Medtronic Cardiac Rhythm Disease Management2009-05-01
OVATIO CRT (P060027/S013)MicroPort CRM USA, Inc.2009-05-01
VIRTUOSO/VIRTUOSO II DR/VR ICD/SECURA DR/VR ICD/MAXIMO II DR/VR ICD (P980016/S165)Medtronic Cardiac Rhythm Disease Management2009-05-01
OVATIO VR/DR (P980049/S047)MicroPort CRM USA, Inc.2009-05-01
CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S207)ABBOTT MEDICAL2009-04-30
SJM MASTERS VALVED GRAFT (P810002/S070)ABBOTT MEDICAL2009-04-30
LATTITUDE INDUCTIVE COMMUNICATOR (P910077/S092)Boston Scientific2009-04-28
ATTAIN OTW (P010015/S067)Medtronic, Inc.2009-04-28
PROMOTE / PROMOTE+ CRT-D (P030054/S121)ABBOTT MEDICAL2009-04-28
CADENCE ICD SYSTEM (P910023/S208)ABBOTT MEDICAL2009-04-28
MYNX VASCULAR CLOSURE DEVICE (P040044/S013)Cordis US Corporation2009-04-28
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