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Cardiovascular

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

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RecordFirmDate
CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD (P850089/S093)Medtronic Cardiac Rhythm Disease Management2013-04-18
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S024)Edwards Lifesciences, LLC2013-04-18
ATTAIN ABILITY LEAD (P080006/S050)Medtronic, Inc.2013-04-18
CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S368)Medtronic Cardiac Rhythm Disease Management2013-04-18
BI-DIRECTIONAL THERAPY COOL PATH DUO IRRIGATED ABLATION CATHETERS (P110016/S006)ABBOTT MEDICAL2013-04-18
WALLSTENT (VENOUS) ENDOPROSTHESIS (P980033/S031)Boston Scientific Corporation2013-04-18
POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM (P040002/S039)Endologix, LLC2013-04-16
LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S041)Zoll Manufacturing Corporation2013-04-16
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROTHESIS (P860057/S106)Edwards Lifesciences, LLC2013-04-16
ENDURANT II AUI STENT GRAFT SYSTEM (P100021/S021)Medtronic Vascular2013-04-16
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S067)Terumo Medical Corporation2013-04-15
PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM (P960043/S080)Abbott Vascular, Inc.2013-04-15
INTEGRITY CORONARY STENT SYSTEMS (P030009/S063)Medtronic, Ireland2013-04-12
MODEL 5019 HV SPLITTER/ADAPTOR (P920015/S106)Medtronic, Inc.2013-04-12
THERMOCOOL SF CATHETERS (P990071/S018)Biosense Webster, Inc.2013-04-12
LIFESTENT VASCULAR STENT SYSTEMS (P070014/S036)Bard Peripheral Vascular, Inc.2013-04-12
PUNCTUA, COGNIS, ENERGEN, AND INCEPTA CRT-DS (P010012/S326)Boston Scientific Corp2013-04-12
CELSIUS DS, NAVISTAR DS,NAVISTAR RMT DS, EZ STEER NAV DS CATHETERS (P010068/S028)Biosense Webster, Inc.2013-04-12
CELSIUS THERMOCOOL, CELSIUS RMT THERMOCOOL, NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL CATHETERS (P030031/S042)Biosense Webster, Inc.2013-04-12
RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S009)Medtronic Vascular2013-04-12
CELSIUS, CELSIUS RMT, EZ STEER, EZ STEER DS CATHETERS (P950005/S038)Biosense Webster, Inc.2013-04-12
E-LUMINEXX VASCULAR STENT (P080007/S015)Bard Peripheral Vascular, Inc.2013-04-12
NAVISTAR, NAVISTAR RMT, EZ STEER NAV CATHETERS (P990025/S032)Biosense Webster, Inc.2013-04-12
PUNCTUA, TELIGEN, ENERGEN AND INCEPTA ICDS (P960040/S291)Boston Scientific2013-04-12
NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, EZ STEER THERMOCOOL NAV CATHETERS (P040036/S031)Biosense Webster, Inc.2013-04-12
REVO MRI IPG (P090013/S090)Medtronic, Inc.2013-04-11
CAPSUREFIX LEAD, APSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE LEAD (P930039/S084)Medtronic, Inc.2013-04-11
ATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD (P010015/S195)Medtronic, Inc.2013-04-11
CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, EXCELLENCE SS+ LEAD, IMPULSE II LEAD (P850089/S094)Medtronic Cardiac Rhythm Disease Management2013-04-11
ATTAIN ABILITY LEAD (P080006/S051)Medtronic, Inc.2013-04-11
END CAP, SIZING SLEEVE, UPSIZING SLEEVE (P900061/S119)Medtronic Cardiac Rhythm Disease Management2013-04-11
ATTAIN STARFIX LEAD (P060039/S043)Medtronic, Inc.2013-04-11
CAPSURE LEAD, SERVICE KIT-PACEMAKER REPAIR KIT (P890003/S271)Medtronic, Inc.2013-04-11
ANCHORING SLEEVE KIT, SELECTSECURE LEAD (P030036/S055)Medtronic Cardiac Rhythm Disease Management2013-04-11
RF CONDUCTR 5 MM (7FR, 8FR TIP), RF CONDUCTR 4 MM (7FR), RF CONTACTR 5 MM (7FR, 8FR TIP), RF CONTACTR 5 MM (7FR, 8FR TIP (P930029/S039)Medtronic, Inc.2013-04-11
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S006)Boston Scientific Corporation2013-04-11
ADVISA DR IPG,ADVISA DR MRI IPG (P980035/S316)Medtronic, Inc.2013-04-11
CAPSURE EPICARDIAL PACING LEAD (P950024/S047)Medtronic, Inc.2013-04-11
DF-1 CONNECTOR PORT PIN PLUG, IS-1 CONNECTOR PORT PIN PLUG KIT, SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE SVC (P920015/S107)Medtronic, Inc.2013-04-11
TRANSVENE LEAD (P980050/S080)Medtronic, Inc.2013-04-11
CONSULTA CRT-P, SYNCRA CRT-P (P010015/S196)Medtronic, Inc.2013-04-11
CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S088)Medtronic Cardiac Rhythm Disease Management2013-04-11
CAPSUREFIX MRI LEAD (P090013/S089)Medtronic, Inc.2013-04-11
PROMOTE, PROMOTE+. PROMOTE RF, PROMOTE ACCEL, UNIFY, QUICKSITE, QUICKFLEX, (P030054/S244)ABBOTT MEDICAL2013-04-11
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S010)Boston Scientific Corp2013-04-10
BRAVA CRT-D, CONCERTOII CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA S CRT-D, VIVA XT (P010031/S366)Medtronic Cardiac Rhythm Disease Management2013-04-04
VITATRON C20 SR IPG,VITATRON C60 DR IPG,VITATRON T20 SR IPG,VITATRON T60 DR IPG (P990001/S110)Medtronic, Inc.2013-04-04
INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO VR ICD,PROTECTA ICD,PROTECTA XT ICD, SECURA ICD,VIRTUOS (P980016/S404)Medtronic Cardiac Rhythm Disease Management2013-04-04
MAXIMOII ICD, PROTECTA ICD,PROTECTA XT ICD, SECURA ICD, VIRTUOSOII DR/VR ICD (P980016/S403)Medtronic Cardiac Rhythm Disease Management2013-04-04
EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER (P910001/S059)Spectranetics Corp.2013-04-04
ADAPTA,VERSA,SENSIA IPG,ADVISA DRIPG,ADVISA MRI IPG, RELIA IPG (P980035/S314)Medtronic, Inc.2013-04-04
CONSULTA CRT-P,SYNCRA CRT-P (P010015/S194)Medtronic, Inc.2013-04-04
REVO MRI IPG (P090013/S088)Medtronic, Inc.2013-04-04
BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAX (P010031/S367)Medtronic Cardiac Rhythm Disease Management2013-04-04
MEDTRONIC EVERA XT DR, EVERA XT VR, EVERA S DR, EVERA S VR IMPLANTABLE CARDIOVERTER DEFINRILLATORS (P980016/S382)Medtronic Cardiac Rhythm Disease Management2013-04-03
MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS (P890003/S259)Medtronic, Inc.2013-04-03
3F AORTIC BIOPROSTHESIS (P060025/S011)Medtronic, Inc.2013-04-02
HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S018)Medtronic2013-04-02
BLAZER PRIME HTD (P920047/S056)Boston Scientific Corp2013-04-01
THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS) (P060040/S025)ABBOTT MEDICAL2013-04-01
BLAZER PRIME XP CARDIAC ABLATION CATHETERS (P020025/S039)Boston Scientific2013-04-01
THORATEC VENTRICULAR ASSIST DEVICE (P870072/S052)Thoratec Laboratories Corp.2013-04-01
OPEN PIVOT HEART VALVE (P990046/S031)Medtronic Ats Medical, Inc.2013-03-29
ADVISA MRI (A2DR01) (P980035/S315)Medtronic, Inc.2013-03-28
CONSULTA CRT-P,SYNCRA CRT-P (P010015/S192)Medtronic, Inc.2013-03-28
BRAVA CRT-P,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S364)Medtronic Cardiac Rhythm Disease Management2013-03-28
SPACE DATA COLLECTOR AND NIKON ROUTER (P980016/S401)Medtronic Cardiac Rhythm Disease Management2013-03-28
REVO MRI IPG (P090013/S086)Medtronic, Inc.2013-03-28
ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG (P980035/S312)Medtronic, Inc.2013-03-28
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S073)Medtronic, Inc.2013-03-27
RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S008)Medtronic Vascular2013-03-27
HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S017)Medtronic2013-03-27
CONCERTO ICD,CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, PROTECTA CRT-D, DF4 CRT-D, XT CRT-D, XT DR, XT DF4 CRT-D (P010031/S310)Medtronic Cardiac Rhythm Disease Management2013-03-26
BRAVA CRT-D, CONCENTOIICRT-D, CONSULTA ICD,MAXIMOII CRT,PROTECTA CRT-D, PROTECAXT CRT-D,VIVA S CRT-D,VIVAXT CRT-D (P010031/S365)Medtronic Cardiac Rhythm Disease Management2013-03-26
PARADYM VR AND DR, PARADYM RF VR AND DR (P980049/S081)MicroPort CRM USA, Inc.2013-03-26
PARADYM/PARADYM RF CRT-D (P060027/S048)MicroPort CRM USA, Inc.2013-03-26
ADAPTA,VERSA,SENSIA,ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG (P980035/S313)Medtronic, Inc.2013-03-26
CAPSUREFIX MRI LEAD (P090013/S084)Medtronic, Inc.2013-03-26
CONSULTA CRT-P, SYNCRA CRT-P (P010015/S193)Medtronic, Inc.2013-03-26
ADVISA DR IPG, AT501 DDDRP PACING SYSTEM IPG (P980035/S272)Medtronic, Inc.2013-03-26
REPLY SR AND DR, ESPRIT SR AND DR (P950029/S078)MicroPort CRM USA, Inc.2013-03-26
MAXIMOII ICD (P980016/S402)Medtronic Cardiac Rhythm Disease Management2013-03-26
ENTRUST ICD, PROTECTA DF4 ICD, ICD, XT DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO ICD VIRTUOSO II DR/VR ICD (P980016/S357)Medtronic Cardiac Rhythm Disease Management2013-03-26
PARADYM CRT-D, PARADYM RF CRT-D (P060027/S049)MicroPort CRM USA, Inc.2013-03-26
PARADYM/PARADYM RF ICD (P980049/S080)MicroPort CRM USA, Inc.2013-03-26
RENO MRI IPG (P090013/S087)Medtronic, Inc.2013-03-26
STRATOS (P070008/S039)Biotronik, Inc.2013-03-25
ECURO, EFFECTA, ENTOVIS, ESTELLA, EVIA (P950037/S119)Biotronik, Inc.2013-03-25
LUMAX (P050023/S061)Biotronik, Inc.2013-03-25
PROMUS ELEMENT PLUS EVEROLIMUS-ELEUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S035)Boston Scientific Corp2013-03-25
ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM (P100021/S023)Medtronic Vascular2013-03-25
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S042)Abbott Vascular2013-03-22
ARCTIC FRONT CRYOABLATION CATHETER, ARCTIC FRONT ADVANCE CRYOABLATION CATHETER (P100010/S023)Medtronic Cryocath, LP2013-03-21
MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S399)Medtronic Cardiac Rhythm Disease Management2013-03-20
REPLY/ESPRIT SR/DR PACEMAKERS (P950029/S077)MicroPort CRM USA, Inc.2013-03-20
ADAPTA VERSA, SENSIA IPG, RELIA IPG (P980035/S310)Medtronic, Inc.2013-03-20
CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S362)Medtronic Cardiac Rhythm Disease Management2013-03-20
CONSULTA CRT-P, SYNCRA CRT-P (P010015/S191)Medtronic, Inc.2013-03-20
ADVISA DR IPG, ADVISA MRI IPG (P980035/S309)Medtronic, Inc.2013-03-20
MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO DR/VR ICD (P980016/S397)Medtronic Cardiac Rhythm Disease Management2013-03-20
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Every clearance here is in the API, with alerts when new ones post.