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Cardiovascular

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

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RecordFirmDate
ELCA CORONARY ATHRECTOMY CATHETERS (P910001/S070)Spectranetics Corp.2014-04-17
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S134)Boston Scientific Corp2014-04-17
PERCLOSE PROGLIDE/ AT AND PROSTAR XL (P960043/S088)Abbott Vascular, Inc.2014-04-17
RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STNET SYSTEM (P110013/S038)Medtronic Vascular2014-04-17
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S051)Edwards Lifesciences, LLC2014-04-17
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S091)Medtronic, Inc.2014-04-17
SMART AND SMART CONTROL VASCULAR STENT SYSTEM (P120002/S001)Cordis US Corporation2014-04-16
SMART AND SMART CONTROL NITINOL STENT SYSTEM (P020036/S026)Cordis US Corporation2014-04-16
PARADYM RF VR (P980049/S095)MicroPort CRM USA, Inc.2014-04-16
PARADYM RF CRT-D (P060027/S062)MicroPort CRM USA, Inc.2014-04-16
RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S004)Bolton Medical, Inc.2014-04-16
ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S370)Medtronic, Inc.2014-04-15
XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S121)Abbott Vascular, Inc.2014-04-15
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S065)Abbott Vascular2014-04-15
S-ICD SYSTEM (P110042/S028)Boston Scientific Corporation2014-04-15
EVERA S DR ICD, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD,PROTECTA ICD, PROTECTA (P980016/S475)Medtronic Cardiac Rhythm Disease Management2014-04-15
REVO MRI IPG (P090013/S137)Medtronic, Inc.2014-04-15
MULTI-LINK VISION / MULTI-LINK MINI VISION / MULTI-LINK 8 CORONARY STENT SYSTEMS (P020047/S057)Abbott Vascular2014-04-15
BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA S CRT-D, VIVA XT (P010031/S436)Medtronic Cardiac Rhythm Disease Management2014-04-15
DYNAGEN EL & MINI ICD'S; INOGEN EL & MINI ICD'S; ORIGEN EL & MINI ICD'S; TELIGEN ICD (P960040/S306)Boston Scientific2014-04-11
MODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM) (P910077/S139)Boston Scientific2014-04-11
DYNAGEN & DYNAGEN X4 CRT-D'S; INOGEN & INOGEN X4 CRT-D'S; ORIGEN & ORIGEN X4 CRT-D'S; COGNIS CRT-D (P010012/S341)Boston Scientific Corp2014-04-11
CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S420)Medtronic Cardiac Rhythm Disease Management2014-04-11
ADAPTA, VERSA, SENSIA IPG, RELIA IPG (P980035/S371)Medtronic, Inc.2014-04-11
MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S458)Medtronic Cardiac Rhythm Disease Management2014-04-11
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S091)Boston Scientific Corp2014-04-11
GORE VIABAHN ENDOPROSTHESIS AND GORE BIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S001)W. L. Gore & Associates, Inc.2014-04-10
SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S081)St. Jude Medical, Inc.2014-04-10
CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES (P010015/S205)Medtronic, Inc.2014-04-10
MICRONY FAMILY OF PACEMAKERS (P970013/S050)ABBOTT MEDICAL2014-04-10
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICES (P010031/S381)Medtronic Cardiac Rhythm Disease Management2014-04-10
FRONTIER/ FRONTIER II /ANTHEM FAMILY OF CRT-P'S (P030035/S098)ABBOTT MEDICAL2014-04-10
EPIC HF/ATLAS + HF/QUANDRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S (P030054/S226)ABBOTT MEDICAL2014-04-10
EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S476)Medtronic Cardiac Rhythm Disease Management2014-04-10
CADENCE/ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S (P910023/S297)ABBOTT MEDICAL2014-04-10
AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S220)ABBOTT MEDICAL2014-04-10
BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S437)Medtronic Cardiac Rhythm Disease Management2014-04-10
HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S035)Medtronic2014-04-10
GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S002)W. L. Gore & Associates, Inc.2014-04-10
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSEM (P060033/S090)Medtronic, Inc.2014-04-09
PARADYM RF CRT-D9750 (P060027/S060)MicroPort CRM USA, Inc.2014-04-09
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS (P060040/S034)ABBOTT MEDICAL2014-04-09
REPLY SR, REPLY DR, ESPIRIT SR, ESPIRIT DR (P950029/S088)MicroPort CRM USA, Inc.2014-04-09
RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S037)Medtronic Vascular2014-04-09
PARADYM VR 8750, PARADYM DR 8750, PARADYM RF CRT-D (P980049/S093)MicroPort CRM USA, Inc.2014-04-09
MULTI-LINK ULTRA RX AND OTW CORONARY STENT SYSTEM (P970020/S079)Abbott Vascular, Inc.2014-04-07
BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S434)Medtronic Cardiac Rhythm Disease Management2014-04-04
BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D (P010031/S431)Medtronic Cardiac Rhythm Disease Management2014-04-04
BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS (P920047/S067)Boston Scientific Corp2014-04-04
BLAZER II XP,BLAZER PRIME XP, INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S055)Boston Scientific2014-04-04
ATTAIN STARFIX LEAD (P060039/S058)Medtronic, Inc.2014-04-04
EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD (P980016/S470)Medtronic Cardiac Rhythm Disease Management2014-04-04
ASSURITY, ASSURITY+ AND ENDURITY FAMILIES OF PACEMAKER DEVICES (P880086/S240)ABBOTT MEDICAL2014-04-04
CONSULTA CRT-P, SYNCRA CRT-P (P010015/S235)Medtronic, Inc.2014-04-04
HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S041)Medtronic2014-04-04
EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S473)Medtronic Cardiac Rhythm Disease Management2014-04-04
REVO MRI IPG (P090013/S135)Medtronic, Inc.2014-04-04
ALLURE AND ALLURE QUADRA FAMILIES OF CRT-P DEVICES (P030035/S118)ABBOTT MEDICAL2014-04-04
ADAPTA,VERSA,SENSIA IPG, ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG (P980035/S368)Medtronic, Inc.2014-04-04
HEARTMATE II LVAS (P060040/S033)ABBOTT MEDICAL2014-04-03
ARCTIC FRONT CRYOABLATION CATHETER; ARCTIC FRONT ADVANCE CRYOABLATION CATHETER (P100010/S035)Medtronic Cryocath, LP2014-04-03
COMPLETE SE VASCULAR STENT SYSTEM-ILIAC (P090006/S014)Medtronic Vascular2014-04-03
COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA (P110040/S005)Medtronic Vascular2014-04-03
MEDTRONIC COREVALUE TM SYSTEM, (P130021/S003)Medtronic, Inc.2014-04-03
TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S040)Medtronic Vascular2014-04-03
BIOCOR AND EPIC VALVE (P040021/S025)ABBOTT MEDICAL2014-04-02
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S017)Boston Scientific Corporation2014-04-02
CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D AND PROTECTA XT CRT-D (P010031/S432)Medtronic Cardiac Rhythm Disease Management2014-04-02
GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S062)W. L. Gore & Associates, Inc.2014-04-02
ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (P020018/S050)Cook, Inc.2014-04-02
MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD AND VIRTUOSO II DR VR ICD (P980016/S471)Medtronic Cardiac Rhythm Disease Management2014-04-02
INCEPTA,ENERGEN,PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATORS (P010012/S348)Boston Scientific Corp2014-03-31
INCEPTA,ENERGEN,PUNCTUA,TELIGEN IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATORS (P960040/S311)Boston Scientific2014-03-31
REGENT/STANDARD/MASTERS MECHANICAL HEART VALVES (P810002/S089)ABBOTT MEDICAL2014-03-31
PROMOTE,QUADRA ASSURA,UNIFY,UNIFY ASSURA,UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S259)ABBOTT MEDICAL2014-03-31
IDENTITY,SUSTAINXL,VERITY,VICTORY,ZEPHYR,ACCENT FAMILIES OF PACEMAKER DEVICES (P880086/S238)ABBOTT MEDICAL2014-03-31
CURRENT,FORTIFY,FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S328)ABBOTT MEDICAL2014-03-31
ANTHEM FAMILY OF CRT-P DEVICES (P030035/S116)ABBOTT MEDICAL2014-03-31
VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM/ LEAD TUNNELER KIT (P830060/S078)Boston Scientific2014-03-31
ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S012)LeMaitre Vascular, Inc.2014-03-28
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S030)ABBOTT MEDICAL2014-03-28
FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM (P100028/S003)Cook Medical Incorporated2014-03-28
MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (MYNX PRODUCT FAMILY) (P040044/S049)Cordis US Corporation2014-03-28
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S028)Edwards Lifesciences, LLC2014-03-28
SUPERA PERIPHERAL STENT SYSTEM (P120020)Abbott Vascular (Idef Technologies Inc)2014-03-28
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S041)Edwards Lifesciences, LLC2014-03-28
CARPENTIER-EDEARDS DURAFLEX LOW PRESSURE PROCINE MITRAL BIOPROSTHESIS (P870077/S060)Edwards Lifesciences, LLC2014-03-27
CARPENTIER-EDWARDS PROCINE AORTIC BIOPROSTHESIS ,PROCINE MITRAL BIOPROSTHESIS (P870056/S066)Edwards Lifesciences, LLC2014-03-27
LIFESTENT VASCULAR STENT SYSTEMS (P070014/S042)Bard Peripheral Vascular, Inc.2014-03-27
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S049)Edwards Lifesciences, LLC2014-03-27
EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S045)Edwards Lifesciences, LLC2014-03-27
CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S049)Edwards Lifesciences, LLC2014-03-27
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S036)Edwards Lifesciences, LLC2014-03-27
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS WITH TERMAFIX TISSUE PROCESS, RSR PERICARDIAL AORTIC BIOP (P860057/S120)Edwards Lifesciences, LLC2014-03-27
EXPRESS 2 MONORAIL AND OVER-THE-WIRE (P020009/S118)Boston Scientific Scimed, Inc.2014-03-26
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S124)Boston Scientific Scimed, Inc.2014-03-26
HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S032)Medtronic2014-03-26
CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S047)Boston Scientific Corp2014-03-26
BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S054)Boston Scientific2014-03-26
OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEMS (P120006/S005)Endologix, LLC2014-03-26
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Every clearance here is in the API, with alerts when new ones post.