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Cardiovascular

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

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RecordFirmDate
BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S019)Bard Peripheral Vascular, Inc.2010-10-27
TALENT THORACIC STENT GRAFT SYSTEM (P070007/S021)Medtronic Vascular2010-10-26
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S008)Syncardia Systems, LLC2010-10-26
MYNX CADENCE VASCULAR CLOSURE DEVICE (P040044/S033)Cordis US Corporation2010-10-22
FLEXTEND EXTENDABLE/RETRACTABLE ENDOCARDIAL PACING LEADS (P960006/S027)Boston Scientific2010-10-20
ENTRUST ICD FAMILY (P980035/S166)Medtronic, Inc.2010-10-19
ENRYTHM IPG (P980016/S237)Medtronic Cardiac Rhythm Disease Management2010-10-19
ICDS (P910023/S250)ABBOTT MEDICAL2010-10-19
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S051)Medtronic, Inc.2010-10-19
CARELINK DDMA SOFTWARE AND CARELINK MONITOR (P890003/S191)Medtronic, Inc.2010-10-19
GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S106)Medtronic, Ireland2010-10-19
DRIVER & MICRODRIVER CORONARY STENT SYSTEMS (P030009/S042)Medtronic, Ireland2010-10-19
CRT-DS (P030054/S171)ABBOTT MEDICAL2010-10-19
LIFESTENT VASCULAR STENT SYSTEMS (P070014/S014)Bard Peripheral Vascular, Inc.2010-10-18
SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICD (P980016/S260)Medtronic Cardiac Rhythm Disease Management2010-10-15
CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D CONCERTO (P010031/S216)Medtronic Cardiac Rhythm Disease Management2010-10-15
TELIGEN PULSE GENERATORS (P960040/S224)Boston Scientific2010-10-15
MARQUIS/MAXIMO/INTRINSIC ICDS (P980016/S259)Medtronic Cardiac Rhythm Disease Management2010-10-15
INSYNC III/II MARQUIS/INSYNC SENTRY/MAXIMO ICDS (P010031/S215)Medtronic Cardiac Rhythm Disease Management2010-10-15
ATS 3F AORTIC BIOPROSTHESIS (P060025/S007)Medtronic, Inc.2010-10-15
ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM IPGS (P980035/S188)Medtronic, Inc.2010-10-15
COGNIS PULSE GENERATORS (P010012/S244)Boston Scientific Corp2010-10-15
SPECTRANETICS ELCA LASER CATHETERS (P910001/S037)Spectranetics Corp.2010-10-15
ACCULINK CAROTID STENT SYSTEM (P040012/S033)Abbott Vascular2010-10-15
MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS (P970020/S057)Abbott Vascular, Inc.2010-10-15
CORONARY DILATATION CATHETERS (P810046/S240)Advanced Cardiovascular Systems, Inc.2010-10-15
MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS (P020047/S024)Abbott Vascular2010-10-15
LIFESTENT VASCULAR STENT SYSTEMS (P070014/S018)Bard Peripheral Vascular, Inc.2010-10-14
EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S006)Boston Scientific Corporation2010-10-13
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S048)Abbott Vascular, Inc.2010-10-12
PULSE GENERATOR (P010012/S257)Boston Scientific Corp2010-10-08
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S016)Boston Scientific Corp2010-10-08
PULSE GENERATOR (P960040/S237)Boston Scientific2010-10-08
CAPSURE IMPLANTABLE PULSE GENERATOR (P890003/S200)Medtronic, Inc.2010-10-08
HEARTMATE II LVAS (P060040/S013)ABBOTT MEDICAL2010-10-08
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S053)W. L. Gore & Associates, Inc.2010-10-08
EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S007)Boston Scientific Corporation2010-10-08
PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S010)Medtronic Vascular, Inc.2010-10-04
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S013)Boston Scientific Corp2010-10-04
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S047)Abbott Vascular, Inc.2010-10-04
EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S003)Boston Scientific Corporation2010-10-04
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S072)ABBOTT MEDICAL2010-10-01
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S192)ABBOTT MEDICAL2010-10-01
CADENCE FAMILY OF ICDS (P910023/S248)ABBOTT MEDICAL2010-10-01
CELSIUS CATHETER, NON-TEMPERATURE SENSING ABLATION CATHETERS, INTERFACE CABLES (P950005/S030)Biosense Webster, Inc.2010-10-01
MICRONY FAMILY OF PACEMAKERS (P970013/S035)ABBOTT MEDICAL2010-10-01
NAVISTAR CATHETER, INTERFACE CABLES (P990025/S025)Biosense Webster, Inc.2010-10-01
NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS (P010068/S020)Biosense Webster, Inc.2010-10-01
CELSIUS THERMOCOOL & NAVISTAR THERMOCOOL (P030031/S028)Biosense Webster, Inc.2010-10-01
CONTRAK RENEWAL TR/TR2 PULSE GENERATOR (P030005/S071)Guidant Corp.2010-10-01
AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S014)ABBOTT MEDICAL2010-10-01
NAVISTAR THERMOCOOL (P040036/S021)Biosense Webster, Inc.2010-10-01
EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S167)ABBOTT MEDICAL2010-10-01
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S068)St. Jude Medical, Inc.2010-10-01
EZ STEER THERMOCOOL CATHETERS (P990071/S010)Biosense Webster, Inc.2010-10-01
THORATEC HEARTMATE2 LVAS (P060040/S008)ABBOTT MEDICAL2010-09-30
VIRTUOSO, VIRTUOSO 2, SECURA AND MAXIMO 2 (P010031/S208)Medtronic Cardiac Rhythm Disease Management2010-09-29
LATITUDE COMMUNICATORS & PROGRAMMER (P910077/S107)Boston Scientific2010-09-29
CONCERTO, CONCERTO2 CONSULTA AND MAXIMO 2 (P980016/S252)Medtronic Cardiac Rhythm Disease Management2010-09-29
RELIANCE LEADS (P910073/S084)Boston Scientific2010-09-28
QUICKFLEX FAMILY OF LEFT HEART LEADS (P030054/S170)ABBOTT MEDICAL2010-09-24
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S098)Boston Scientific Corp2010-09-23
EPIC/+/II, ATLAS/+/II, CURRENT/CURRENT+ AND PROMOTE+ FAMILY OF DEVICES (P030054/S165)ABBOTT MEDICAL2010-09-23
FORTIFY VR/DR (P910023/S239)ABBOTT MEDICAL2010-09-23
ON-X PROSTHETIC HEART VALVE (P000037/S019)On-X Life Technologies, Inc.2010-09-23
EPIC/+/II, ATLAS/+/II, CURRENT/CURRENT+ AND PROMOTE+ FAMILY OF DEVICES (P910023/S246)ABBOTT MEDICAL2010-09-23
UNIFY CRT-D (P030054/S157)ABBOTT MEDICAL2010-09-23
EASYTRAK (P010012/S253)Boston Scientific Corp2010-09-22
THINLINE/FINELINE (P960004/S046)Boston Scientific2010-09-22
ACUITY STEERABLE/SPIRAL (P050046/S007)Guidant Corp.2010-09-22
TELIGEN HE DR/VR /CONFIENT (P960040/S233)Boston Scientific2010-09-22
HANCOCK APICAL LEFT VENTRICLE CONNECTOR (P870078/S008)Medtronic, Inc.2010-09-20
PHILOS DR/SR/PHILOS II DR /SR/CYLOS DR/DR-T/VR/EVIA DR/DR-T/ENTOVIS DR PULSE GENERATORS (P950037/S086)Biotronik, Inc.2010-09-17
RENEWAL (P030005/S069)Guidant Corp.2010-09-17
COROX OTW/STRATOS LV/LV-T (P070008/S018)Biotronik, Inc.2010-09-17
VITALITY/PRIZM/CONFIENT/TELIGEN (P960040/S232)Boston Scientific2010-09-17
FREEZOR/FREEZOR XTRA SURGICAL/FREEZOR MAX SURGICAL CATHETERS AND CRYOCONSOLE (P020045/S034)Medtronic Cryocath, LP2010-09-17
LIVIAN/RENEWAL/COGNIS (P010012/S252)Boston Scientific Corp2010-09-17
LEXOS/LUMOS ICDS (P000009/S041)Biotronik, Inc.2010-09-17
LINOX SMART STEROID-ELUTING DUAL-COIL ICD LEADS (P980023/S038)Biotronik, Inc.2010-09-17
LUMAX ICDS/COROX OTW UP STEROID (P050023/S037)Biotronik, Inc.2010-09-17
BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS) (P010012/S230)Boston Scientific Corp2010-09-16
BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S010)Bard Peripheral Vascular2010-09-15
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S036)W. L. Gore & Associates, Inc.2010-09-15
GORE HELEX SEPTAL OCCLUDER (P050006/S018)W. L. Gore & Associates, Inc.2010-09-15
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S055)W. L. Gore & Associates, Inc.2010-09-15
GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S019)W. L. Gore & Associates, Inc.2010-09-15
SPECTRANTICS SLS II LASER SHEATH (P960042/S020)Spectranetics (Philips)2010-09-15
GORE VIABAHN ENDOPROSTHESIS (P040037/S029)W. L. Gore & Associates, Inc.2010-09-15
VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S031)Vascular Solutions, Inc.2010-09-15
BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S012)Bard Peripheral Vascular, Inc.2010-09-15
SPECTRANTICS SLS II LASER SHEATH (P960042/S021)Spectranetics (Philips)2010-09-15
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S038)Abbott Vascular, Inc.2010-09-15
E-LUMINEXX VASCULAR STENT (P080007/S003)Bard Peripheral Vascular, Inc.2010-09-15
OVATIO CRT & SITUS OTW LV (P060027/S027)MicroPort CRM USA, Inc.2010-09-14
CONTAK CD/EASYTRAK CRT-D SYSTEM (P010012/S254)Boston Scientific Corp2010-09-14
VENTAK AV AICD SYSTEM (P960040/S234)Boston Scientific2010-09-14
DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S044)Medtronic, Ireland2010-09-14
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S058)Medtronic, Inc.2010-09-14
CONTAK RENEWAL TR CRT-P SYSTEM (P030005/S070)Guidant Corp.2010-09-14
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