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Cardiovascular

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

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RecordFirmDate
BOSTON SCIENTIFIC CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (CAROTID WALLSTENT ENDOPROSTHESIS) (P050019/S007)Boston Scientific Corp2011-05-02
VENTAK/VENTAK P/VENTAK P2 FAMILIES (P830060/S068)Boston Scientific2011-04-29
THINLINE/FINELINE FAMILIES (P960004/S049)Boston Scientific2011-04-29
FREEZOR/FREEZOR XTRA/FREEZOR MAX CRYOABLATION CATHETERS AND THE CRYOCONSOLE (P020045/S038)Medtronic Cryocath, LP2011-04-29
SWEET TIP RX/SWEET PICOTIP RX/FLEXTEND FAMILIES (P960006/S030)Boston Scientific2011-04-29
UNIVERSAL CRYOCONSOLE (P020045/S036)Medtronic Cryocath, LP2011-04-29
ENDOTAK RELIANCE (P910073/S095)Boston Scientific2011-04-29
DELTA/VISTA FAMILIES (P840068/S049)Boston Scientific2011-04-29
VIGOR DR/SR/DISCOVERY/MERIDIAN FAMILIES (P940031/S071)Boston Scientific2011-04-29
SELUTE LEAD FAMILY (P950001/S022)Boston Scientific2011-04-29
VENTAK/VENTAK P/VENTAK P2 FAMILIES (P890061/S019)Boston Scientific2011-04-29
MEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD (P080006/S005)Medtronic, Inc.2011-04-29
BALLOON CATHETER (P100010/S009)Medtronic Cryocath, LP2011-04-29
VENTAK AV/VENTAK PRIZM DR/VR/VITALITY/CONFIENT/LIVIAN FAMILIES (P960040/S243)Boston Scientific2011-04-29
VENTAK PRX/MINI FAMILIES (P910077/S113)Boston Scientific2011-04-29
VENTAK/VENTAK P/VENTAK P2 FAMILIES (P930035/S020)Boston Scientific2011-04-29
XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S066)Abbott Vascular, Inc.2011-04-29
LATITUDE COMMUNICATORS (P910077/S112)Boston Scientific2011-04-29
ACUITY STEERABLE FAMILY (P050046/S010)Guidant Corp.2011-04-29
XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S065)Abbott Vascular, Inc.2011-04-29
ENDOTAK FAMILY (P910073/S096)Boston Scientific2011-04-29
CONTAK CD/EASYTRAK/LIVIAN/COGNIS/ACUITY SPIRAL FAMILIES (P010012/S266)Boston Scientific Corp2011-04-29
CONTAK RENEWAL TR FAMILY (P030005/S074)Guidant Corp.2011-04-29
RES-Q/RES-Q MICRON FAMILIES (P940008/S027)Boston Scientific2011-04-29
CADENCE ICDS (P910023/S253)ABBOTT MEDICAL2011-04-25
EPIC HF CRT-DS (P030054/S176)ABBOTT MEDICAL2011-04-25
ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS) (P100023)Boston Scientific Corp2011-04-22
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S042)Spectranetics Corp.2011-04-20
RELIATY / MODEL 3145 FAMILY OF PACING SYSTEM ANALYZERS (P950037/S088)Biotronik, Inc.2011-04-20
ST JUDE MEDICAL TRIFECTA VALVE (P100029)ABBOTT MEDICAL2011-04-20
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S063)Medtronic, Inc.2011-04-20
GORE VIABAHN ENDOPROSTHESIS & GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S033)W. L. Gore & Associates, Inc.2011-04-20
TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S025)Medtronic Vascular2011-04-19
LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S023)Zoll Manufacturing Corporation2011-04-19
FREESTYLE AORTICROOT BIOPROSTHESIS (P970031/S032)Medtronic, Inc.2011-04-15
IMPLANTABLE CV DEFIBRILLATOR/PACEMAKER PROGRAMMER/ICD MONITORING SYSTEM (P000009/S042)Biotronik, Inc.2011-04-15
LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T (P050023/S039)Biotronik, Inc.2011-04-15
HANCOCK II PORCINE BIOPROSTHESIS (P980043/S030)Medtronic, Inc.2011-04-15
IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMING (P950037/S089)Biotronik, Inc.2011-04-15
STRATOS LV/LV-T (P070008/S019)Biotronik, Inc.2011-04-15
MEDTRONIC REVO MRI SURESCAN PACING SYSTEM (P090013/S006)Medtronic, Inc.2011-04-15
MOSIAC PORCINE BIOPROSTHESIS (P990064/S037)Medtronic, Inc.2011-04-15
ENDEAVOR SPRINT CORONARY STENT SYSTEM (P060033/S061)Medtronic, Inc.2011-04-12
TALENT THORACIC STENT GRAFT SYSTEM (P070007/S026)Medtronic Vascular2011-04-12
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S060)Medtronic, Inc.2011-04-12
ANEURX AAADVANTAGE STENT GRAFT (P990020/S043)Medtronic Vascular2011-04-12
DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S050)Medtronic, Ireland2011-04-12
DRIVER/MICRO-DRIVER AND INTEGRITY CORONARY STENT SYSTEMS (P030009/S051)Medtronic, Ireland2011-04-12
TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S027)Medtronic Vascular2011-04-12
AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S018)ABBOTT MEDICAL2011-04-08
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S061)Abbott Vascular, Inc.2011-04-08
AMPLATZER SEPTAL OCCLUDER (P000039/S041)ABBOTT MEDICAL2011-04-08
ST JUDE MEDICAL MECHANICAL HEART VALVE/SJM MASTERS SERIES & SJM REGENT HEART VALVES (P810002/S073)ABBOTT MEDICAL2011-04-08
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM (P960040/S227)Boston Scientific2011-04-08
REPLY (P950029/S058)MicroPort CRM USA, Inc.2011-04-08
IMPLANTABLE PULSE GENERATOR, PACEMAKER (P010012/S247)Boston Scientific Corp2011-04-08
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S066)Terumo Medical Corporation2011-04-08
MULTI-LINK VISION & MULTI-LINK MINI-VISION CORONARY STENT SYSTEM (P020047/S033)Abbott Vascular2011-04-08
ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S004)Medtronic Cryocath, LP2011-04-08
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S061)W. L. Gore & Associates, Inc.2011-04-08
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S062)Abbott Vascular, Inc.2011-04-08
AMPLATZER DUCT OCCLUDER (P020024/S033)ABBOTT MEDICAL2011-04-08
CONTAK RENEWAL TR (P030005/S067)Guidant Corp.2011-04-08
CHILLI COOLED ABLATION SYSTEM (P980003/S025)Boston Scientific Corp2011-04-08
MULTI-LINK ZETA CORONARY STENT SYSTEMS (P970020/S062)Abbott Vascular, Inc.2011-04-08
XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S063)Abbott Vascular, Inc.2011-04-08
ANGIOSCULPT PTCA SCORING BALLOON CATHETER, EASY EXCHANGE (EX0 (P050018/S013)Spectranetics Corp.2011-04-08
ACUITY SPIRAL LEAD (P010012/S264)Boston Scientific Corp2011-04-07
ANJIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S035)Boston Scientific Corp2011-04-07
EZ STEER NAV DS AND QWIKSTAR DS CATHETERS (P010068/S024)Biosense Webster, Inc.2011-04-06
NAVISTAR/RMT/EZ STEER NAV/QWIKSTAR/INTERFACE CABLES (P990025/S028)Biosense Webster, Inc.2011-04-06
MODEL 2490C/G/H/J CARELINK REMOTE HOME MONITOR/2020A ANALYZER (P890003/S217)Medtronic, Inc.2011-04-06
CELSIUS/RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION/INTERFACE CABLES (P950005/S034)Biosense Webster, Inc.2011-04-06
1782 TENDRIL LEADS (P960013/S064)ABBOTT MEDICAL2011-04-06
CELSIUS THERMOCOOL/RMT//NAVISTAR/NAVISTAR RMT/EZ STEER/EZ STEER THERMOCOOL NAV CATHETERS (P030031/S032)Biosense Webster, Inc.2011-04-06
NAVISTAR THERMOCOOL//NAVISTAR RMT//EZ STEER/EZ STEER THERMOCOOL NAV CATHETERS (P040036/S023)Biosense Webster, Inc.2011-04-06
INTERFACE CABLES (P990071/S012)Biosense Webster, Inc.2011-04-06
EVIA FAMILY OF PULSE GENERATORS (P950037/S094)Biotronik, Inc.2011-04-06
MYNX CADENCE VASCULAR CLOSURE DEVICE (P040044/S037)Cordis US Corporation2011-04-05
CADENCE FAMILY OF ICDS (P910023/S254)ABBOTT MEDICAL2011-04-04
CARELINK MONITOR & CARDIOSIGHT READER (P890003/S169)Medtronic, Inc.2011-04-04
ADVISA DR IPG (P980035/S134)Medtronic, Inc.2011-04-04
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S070)St. Jude Medical, Inc.2011-04-04
EPIC HF/ATLAS+HF HAMILY OF CRT-DS (P030054/S177)ABBOTT MEDICAL2011-04-04
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S075)ABBOTT MEDICAL2011-04-04
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S195)ABBOTT MEDICAL2011-04-04
CONSULTA CRT-D/CONCERTO II CRT-D/MAXIMO CRT-D ICDS (P010031/S150)Medtronic Cardiac Rhythm Disease Management2011-04-04
SECURA DR/VR, VIRTUOSO II DR/VR, MAXIMO II DR/VR ICDS (P980016/S187)Medtronic Cardiac Rhythm Disease Management2011-04-04
MICRONY FAMILY OF PACEMAKERS (P970013/S038)ABBOTT MEDICAL2011-04-04
ADAPTA/VERSA/SENSIA & RELIA IPGS (P980035/S208)Medtronic, Inc.2011-04-04
ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VLAVES (P040021/S014)ABBOTT MEDICAL2011-04-01
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S014)Boston Scientific Corp2011-04-01
EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S065)Boston Scientific Scimed, Inc.2011-04-01
VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S059)Boston Scientific Scimed, Inc.2011-04-01
MEDTRONIC ATTAIN ABILITY PLUS MODEL 4296 LEAD (P080006/S002)Medtronic, Inc.2011-04-01
ARCTIC FRONT CARDIAC CRYOBLATION CATHETER (P100010/S002)Medtronic Cryocath, LP2011-04-01
VALIANT THORACIC STENT GRAFT SYSTEM (P100040)Medtronic Vascular2011-04-01
ADAPTA/RELIA/SENSIA/VERSA IPGS (P980035/S207)Medtronic, Inc.2011-03-31
EXPRESS2 MONORAIL & OTW (P020009/S066)Boston Scientific Scimed, Inc.2011-03-31
CHILLI II COOLED ABLATION CATHETER & CABLE (P980003/S024)Boston Scientific Corp2011-03-31
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