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Cardiovascular

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

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RecordFirmDate
ENDOTEX NEXSTENT CAROTID STENT AND MONORAIL (P050025/S002)Boston Scientific2007-04-10
EXPRESS2CORONARY STENT SYSTEM (P020009/S038)Boston Scientific Scimed, Inc.2007-04-04
MULTI-LINK VISION RX CORONARY STENT & MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM (P020047/S009)Abbott Vascular2007-04-04
EXPRESS2 MONORAIL (MR) & OVER-THE-WIRE (OTW) CORONARY STENT SYSTEM (P020009/S037)Boston Scientific Scimed, Inc.2007-04-04
TAXUS EXPRESS PACLITAXEL ELUTING STENT SYSTEM (P030025/S046)Boston Scientific Corp2007-04-04
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S045)Boston Scientific Corp2007-04-04
POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER SYSTEM (P040002/S010)Endologix, LLC2007-04-04
LIBERTE CORONARY STENT SYSTEM (P040016/S023)Boston Scientific Scimed, Inc.2007-04-04
XACT CAROTID STENT SYSTEM (P040038/S010)Abbott Vascular, Inc.2007-03-30
NIRFLEX PREMOUNTED CORONARY STENT SYSTEM (P020040/S006)Medinol, Ltd.2007-03-29
ZEPHYR PULSE GENERATORS MODELS XL DR 5826,DR5820 & SR 5620 (P880086/S139)ABBOTT MEDICAL2007-03-29
POWERLINK SYSTEM WITH VISIFLEX SUREPASS DELIVERY CATHETER SYSTEM (P040002/S009)Endologix, LLC2007-03-29
ANGIOSEAL VASCULAR CLOSURE DEVICE (P930038/S049)Terumo Medical Corporation2007-03-29
CONTAK RENEWAL FAMILY (P010012/S149)Boston Scientific Corp2007-03-29
VITALITY FAMILY (P960040/S144)Boston Scientific2007-03-29
CONTAK RENEWAL TR FAMILY OF PULSE GENERATORS (PGS) (P030005/S042)Guidant Corp.2007-03-29
RIATA FAMILY OF LEADS (P950022/S036)ABBOTT MEDICAL2007-03-28
POSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S020)Boston Scientific Corp2007-03-28
CONTAK & RENEWAL FAMILIES OF CRT-DS (P010012/S146)Boston Scientific Corp2007-03-28
LATITUDE PATIENT MANAGEMENT SYSTEM SOFTWARE (P910077/S071)Boston Scientific2007-03-28
CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S033)Cordis Corp.2007-03-28
PRIZM & VITALITY FAMILIES OF ICDS (P960040/S141)Boston Scientific2007-03-28
VARIOUS MODELS OF PHILOS/AXIOS/PROTOS/CYLOS PG'S (P950037/S049)Biotronik, Inc.2007-03-26
VITRTUOSO MODELS D154AWG/D154VWC (P980016/S095)Medtronic Cardiac Rhythm Disease Management2007-03-26
CONCERTO MODEL C154DWK (P010031/S063)Medtronic Cardiac Rhythm Disease Management2007-03-26
LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S068)Boston Scientific2007-03-23
PROGRAMMER SOFTWARE APPLICAION MODEL 2812, VERSION 2.1 (P960040/S084)Boston Scientific2007-03-23
PRECISE AND PRECISE RX NITINOL STENT SYSTEMS (P030047/S002)Cordis US Corporation2007-03-23
CONTAK RENEWAL 1/3/3HE CRT-D DEVICES (P010012/S036)Boston Scientific Corp2007-03-23
TENDRIL LEAD FAMILY (P960013/S027)ABBOTT MEDICAL2007-03-23
STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S005)Abbott Vascular Devices2007-03-23
STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S004)Abbott Vascular Devices2007-03-23
RIATA ST LEADS (P950022/S037)ABBOTT MEDICAL2007-03-23
ZOOM LATITUDE PROGRAMMING SYSTEM (P910077/S057)Boston Scientific2007-03-23
PROGRAMMER SOFTWARE APPLICATION MODEL 2812, VERSION 1.4 (P960040/S083)Boston Scientific2007-03-23
RIATA LEAD FAMILY (P950022/S035)ABBOTT MEDICAL2007-03-23
NAVISTAR RMT DS CATHETER (P010068/S009)Biosense Webster, Inc.2007-03-21
IBI THERAPY CARDIAC ABLATION SYSTEM (P040014/S006)Irvine Biomedical, Inc.2007-03-16
IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF (P060019)Irvine Biomedical, Inc.2007-03-16
THERAPY DUAL 8 ABLATION CATHETER & IBI-1500T6 CARDIAC ABLATION GENERATOR (P040042/S008)Irvine Biomedical,Inc.(Ibi)2007-03-16
VICTORY AF DR PULSE GENERATOR MODEL 5382 (P880086/S123)ABBOTT MEDICAL2007-03-16
CONTAK RENEWAL 3 RF (P010012/S148)Boston Scientific Corp2007-03-16
MEDTRONIC ENTRUST 35J & VIRTUOSO ICDS (P980016/S094)Medtronic Cardiac Rhythm Disease Management2007-03-15
CONCERTO ICD (P010031/S062)Medtronic Cardiac Rhythm Disease Management2007-03-15
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S048)Terumo Medical Corporation2007-03-15
LATITUDE* PATIENT MANAGEMENT SYSTEM MODELS 6481 AND 6482 (P910077/S072)Boston Scientific2007-03-09
ISOFLEX LEAD FAMILY (P960030/S014)ABBOTT MEDICAL2007-03-08
RIATA FAMILY OF LEADS (P950022/S034)ABBOTT MEDICAL2007-03-08
DEXTRUS STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEADS MODELS 4135,4136 & 4137 (P950037/S048)Biotronik, Inc.2007-03-08
ANGIOSCUPLT SCORING BALLOON CATHETER (P050018/S001)Spectranetics Corp.2007-03-07
POSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S021)Boston Scientific Corp2007-03-06
EASYTRAK IS-1 AND EASYTRAK LV-1 LEADS (P010012/S139)Boston Scientific Corp2007-03-06
2490G/H/J CARELINK MONITOR, 2020A CARDIOSIGHT READER (P890003/S111)Medtronic, Inc.2007-03-02
VARIOUS INSYNC FAMILIES OF CRT-ICDS (P010031/S055)Medtronic Cardiac Rhythm Disease Management2007-03-02
KAPPA & ENPULSE FAMILIES OF PACEMAKERS (P980035/S065)Medtronic, Inc.2007-03-02
SELECTED FAMILIES OF ICDS (P980016/S088)Medtronic Cardiac Rhythm Disease Management2007-03-02
GEM FAMILY OF ICDS (P900061/S068)Medtronic Cardiac Rhythm Disease Management2007-03-02
MAVERICK MONORAIL PTCA CATHETER SYSTEM (P860019/S219)Scimed Life Systems, Inc.2007-03-02
AMPLATZER DUCT OCCLUDER (P020024/S013)ABBOTT MEDICAL2007-03-01
AMPLATZER SEPTAL OCCLUDER (P000039/S018)ABBOTT MEDICAL2007-03-01
FINELINE II & THINLINE II (P960004/S038)Boston Scientific2007-02-28
MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S025)Medtronic Vascular2007-02-23
CUTTING BALLOON ULTRA2 MONORAIL (P950020/S025)Boston Scientific Corp2007-02-23
MEDTRONIC ATTAIN OVER THE WIRE (OTW) LEFT VENTRICULAR LEAD (P010015/S026)Medtronic, Inc.2007-02-23
MULTI-LINK VISION CORONARY STENT SYSTEMS (P020047/S008)Abbott Vascular2007-02-16
VITALITY HE (P960040/S142)Boston Scientific2007-02-16
ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S005)LeMaitre Vascular, Inc.2007-02-16
MULTI-LINK VISION CORONARY STENT SYSTEMS (P970020/S048)Abbott Vascular, Inc.2007-02-16
CONTAK RENEWAL 3 (P010012/S147)Boston Scientific Corp2007-02-16
CONTAK RENEWAL TR (P030005/S041)Guidant Corp.2007-02-16
ANEURX AAADAVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S024)Medtronic Vascular2007-02-15
NIRFLEX PREMOUNTED CORONARY STENT SYSTEM (P020040/S004)Medinol, Ltd.2007-02-15
BIOTRONIK PACING AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P950037/S044)Biotronik, Inc.2007-02-15
NIRFLEX PREMOUNTED CORONARY STENT SYSTEM (P020040/S005)Medinol, Ltd.2007-02-15
CONCERTO MODEL C154DWK IMPLANTABLE DEVICES (P010031/S058)Medtronic Cardiac Rhythm Disease Management2007-02-15
VITALITY & VITALITY AVT FAMILY (P960040/S140)Boston Scientific2007-02-15
BIOTRONIK PACING AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980023/S022)Biotronik, Inc.2007-02-15
THE RIATA ST FAMILY OF LEADS (P950022/S033)ABBOTT MEDICAL2007-02-15
KAINOX A+ ICD LEAD (P000009/S018)Biotronik, Inc.2007-02-15
VIRTUOSO MODELS D154AWG/D154VWC (P980016/S090)Medtronic Cardiac Rhythm Disease Management2007-02-15
LUMAX CRT DEVICE & CARDIOMESSENGER II (P050023/S003)Biotronik, Inc.2007-02-13
PHILOS DR-T AND CYLOS DR-T (P950037/S050)Biotronik, Inc.2007-02-13
CARPENTIER-EDWARDS PERIMOUNT MAGNA BIOPROSTHESES MODELS 3000 AND 3000TFX (P860057/S041)Edwards Lifesciences, LLC2007-02-13
EXPRESS2 CORONARY STENT SYSTEM (P020009/S033)Boston Scientific Scimed, Inc.2007-02-12
LIBERTE MR & OTW CORONARY STENT SYSTEM (P040016/S018)Boston Scientific Scimed, Inc.2007-02-12
TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S039)Boston Scientific Corp2007-02-12
BIOGLUE SURGICAL ADHESIVE (P010003/S009)Cryolife, Inc.2007-02-12
MULTI-LINK VISION & MULTI-LINK MINI VISION CORONARY STENT SYSTEM (P020047/S007)Abbott Vascular2007-02-09
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS 3000, 3000TFX(AORTIC), 6900P & 6900PTFX(MITRAL) (P860057/S037)Edwards Lifesciences, LLC2007-02-08
GORE VIABAHN ENDOPROSTHESIS (P040037/S002)W. L. Gore & Associates, Inc.2007-02-08
VIGOR/ DISCOVERY/ MERIDIAN/ PULSAR (P940031/S059)Boston Scientific2007-02-08
VENTAK PRX/ MINI/ CONTAK CD & CD2 (P910077/S066)Boston Scientific2007-02-08
VENTAK AV /PRIZM/ VITALITY (P960040/S135)Boston Scientific2007-02-08
CONTAK RENEWAL TR (P030005/S039)Guidant Corp.2007-02-08
CONTAK CD/CD2/RENEWAL /RENEWAL 3 (P010012/S142)Boston Scientific Corp2007-02-08
XACT CAROTID STENT SYSTEM (P040038/S007)Abbott Vascular, Inc.2007-02-05
XMI AND XMI-RX THROMBECTOMY CATHETERS (P980037/S019)Boston Scientific Corp2007-02-02
NIRFLEX PREMOUNTED CORONARY STENT SYSTEM (P020040/S002)Medinol, Ltd.2007-02-02
CUTTING BALLOON ULTRA2 MONORAIL (MR) PTCA CATHETER (CUTTING BALLOON) (P950020/S024)Boston Scientific Corp2007-02-02
STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S001)Abbott Vascular Devices2007-02-02
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