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Cardiovascular

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

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RecordFirmDate
VARIOUS FAMILIES OF PACEMAKERS (P990001/S025)Medtronic, Inc.2006-03-31
PROSTAR XL 8 & 10F PVS SYSTEM (P960043/S058)Abbott Vascular, Inc.2006-03-31
VENTAK AV/VR/PRIZM (P960040/S111)Boston Scientific2006-03-31
CONTAK CD/EASYTRAK (P010012/S106)Boston Scientific Corp2006-03-31
CONTAK RENEWAL FAMILY OF CRT-DS (P010012/S112)Boston Scientific Corp2006-03-31
INSYNC/INSYNC II CRT-IPG'S (P010015/S021)Medtronic, Inc.2006-03-31
VENTAK AV/VR/PRIZM (P960040/S113)Boston Scientific2006-03-31
CONTAK RENEWAL TR (P030005/S031)Guidant Corp.2006-03-31
CONTAK CD/EASYTRAK (P010012/S115)Boston Scientific Corp2006-03-31
VARIOUS FAMILIES OF ICD'S (P900061/S062)Medtronic Cardiac Rhythm Disease Management2006-03-31
ST JUDE MEDICAL TORONTO SPV VALVE, MODEL SPA-101 (P970030/S006)St. Jude Medical, Inc.2006-03-31
CONTAK CD/EASYTRAK (P010012/S111)Boston Scientific Corp2006-03-31
KAPPA 400 FAMILY OF PACEMAKERS (P970012/S021)Medtronic, Inc.2006-03-31
CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC PROSTHESIS & CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTH (P900060/S032)Corcym S.r.l.2006-03-30
TAXUS EXPRESS2 CORONARY STENT SYSTEM (P030025/S027)Boston Scientific Corp2006-03-29
QWIKSTAR NAVIGATION/ABLATION CATHETER (P990025/S011)Biosense Webster, Inc.2006-03-28
RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS (P040012/S008)Abbott Vascular2006-03-27
RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM (P040012/S012)Abbott Vascular2006-03-24
EASYTRAK 2 LEADS (P010012/S108)Boston Scientific Corp2006-03-24
RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS (P040012/S004)Abbott Vascular2006-03-24
CONTAK RENEWAL RF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) (P010012/S104)Boston Scientific Corp2006-03-24
RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS (P040012/S014)Abbott Vascular2006-03-24
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPORSTHESIS MODELS 2700TFX, 2800TFX,3000TFX AND 6900PTFX (P860057/S032)Edwards Lifesciences, LLC2006-03-24
RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS (P040012/S013)Abbott Vascular2006-03-24
RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM (P040012/S011)Abbott Vascular2006-03-24
RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM (P040012/S005)Abbott Vascular2006-03-24
RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM (P040012/S007)Abbott Vascular2006-03-24
RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS (P040012/S006)Abbott Vascular2006-03-24
ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S007)Cook, Inc.2006-03-23
ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S020)Medtronic Vascular2006-03-17
ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM (P040012/S003)Abbott Vascular2006-03-16
VARIOUS DEFENDER & ALTO ICDS MODELS & ORCHESTRA PROGRAMMER (P980049/S022)MicroPort CRM USA, Inc.2006-03-15
CHORUS & OPUS RATE-RESPONSIVE PACEMAKERS (P900022/S006)MicroPort CRM USA, Inc.2006-03-15
VARIOUS MODELS OF RATE-RESPONSIVE PACEMAKERS (P950029/S025)MicroPort CRM USA, Inc.2006-03-15
EPIC II VR, EPIC II DR, AND EPIC II+ DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P910023/S088)ABBOTT MEDICAL2006-03-14
FRONTIER AND FRONTIER II BIVENTRICULAR PACING SYSTEMS (P030035/S007)ABBOTT MEDICAL2006-03-14
RENEWAL FAMILY OF CRT-DS (P010012/S105)Boston Scientific Corp2006-03-14
MICRONY PACEMAKERS (P970013/S004)ABBOTT MEDICAL2006-03-14
EPIC/EPIC+ AND ATLAS/ATLAS+ FAMILY OF PULSE GENERATORS (P910023/S101)ABBOTT MEDICAL2006-03-14
SELECT MODELS OF SYNCHRONY, TRILOGY AND AFFINITY FAMILY OF PACEMAKERS, SOLUS,ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, Y (P880086/S114)ABBOTT MEDICAL2006-03-14
META AND TEMPO PACEMAKERS (P900070/S031)St. Jude Medical, Cardiac Rhythm Management Divisi2006-03-14
EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.0M SOFTWARE (P030054/S019)ABBOTT MEDICAL2006-03-14
PARAGON,PHOENIX, MULTILOG, AND SENSORITHM PACEMAKERS (P830045/S094)St. Jude Medical, Inc.2006-03-14
RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS (P040012/S010)Abbott Vascular2006-03-14
AURORA/QUADRA, REFLEX, SIMPLEX,META PACEMAKERS (P820018/S074)St. Jude Medical, Inc.2006-03-14
REGENCY, SENSOLOG III, DIALOG II PACEMAKERS (P880006/S037)St. Jude Medical, Inc.2006-03-14
THINLINE/FINELINE ENDOCARDIAL PACING LEADS (P960004/S034)Boston Scientific2006-03-09
MARQUIS, MAXIMO, INSYNC, ENTRUST, AND INTRINSIC FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P980016/S069)Medtronic Cardiac Rhythm Disease Management2006-03-09
MARQUIS, MAXIMO, INSYNC, ENTRUST, AND INTRINSIC FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P010031/S036)Medtronic Cardiac Rhythm Disease Management2006-03-09
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S009)W. L. Gore & Associates, Inc.2006-03-09
EPIC HF & ATLAS + HF (P030054/S022)ABBOTT MEDICAL2006-03-07
REGENCY PACEMAKERS (P880006/S038)St. Jude Medical, Inc.2006-03-07
VARIOUS MODELS OF SYNCHRONY TRILOGY AND AFFINITY FAMILY OF PACEMAKERS (P880086/S115)ABBOTT MEDICAL2006-03-07
EPIC,EPIC+,ATLAS+, ATLAS, PHOTON MICRO,PHOTON, ICD'S (P910023/S100)ABBOTT MEDICAL2006-03-07
PARAGON AND PHOENIX PACEMAKERS (P830045/S095)St. Jude Medical, Inc.2006-03-07
MICRONY PACEMAKERS (P970013/S005)ABBOTT MEDICAL2006-03-07
INSYNC III BIVENTRICULAR PACING SYSTEM (MODEL 8041) (P010015/S016)Medtronic, Inc.2006-03-07
RIATA ST MODELS 7000, 7001, 7002, 7010, 7011, & 7012 (P950022/S027)ABBOTT MEDICAL2006-03-07
RIATA ST PASSIVE LEAD MODELS 7040, 7041, 7042,7050,7051 AND 7052 (P950022/S028)ABBOTT MEDICAL2006-03-07
FRONTIER CRT-P (P030035/S008)ABBOTT MEDICAL2006-03-07
X-SITE SUTURE-MEDIATED CLOSURE DEVICE (P020035/S002)St. Jude Medical, Inc.2006-03-03
PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S026)Boston Scientific Corp2006-03-03
EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM (P020009/S025)Boston Scientific Scimed, Inc.2006-03-03
LIBERTE CORONARY STENT SYSTEM (P040016/S008)Boston Scientific Scimed, Inc.2006-03-03
ACCELEROMETER TANTALUM CAPACITOR CHANGE (P980016/S066)Medtronic Cardiac Rhythm Disease Management2006-03-02
MICRONY/REGENCY AND FRONTIER (P030054/S020)ABBOTT MEDICAL2006-03-02
GENERATOR AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAMILIES (P030035/S006)ABBOTT MEDICAL2006-03-02
ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S004)LeMaitre Vascular, Inc.2006-03-02
PROGRAMMERS TO SUPPORT VARIOUS PACEMAKERS AND DEFIBRILLATORS (P830045/S093)St. Jude Medical, Inc.2006-03-02
PERCUTANEOUS TRANSPLUMINAL CORONARY ANGIOPLASTY CATHETERS MAVERICK2 MONORAIL PTCA CATHETERS AND NC MONORAIL PTCA CATHETE (P860019/S207)Scimed Life Systems, Inc.2006-03-02
IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P910023/S092)ABBOTT MEDICAL2006-03-02
IMPLANTABLE PULSE GENERATOR, MODEL AT501 (P980035/S050)Medtronic, Inc.2006-03-02
MEDTRONIC EN-TRUST 30J/35J ICD FAMILY (P980016/S067)Medtronic Cardiac Rhythm Disease Management2006-03-02
GENERATOR AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAMILIES (P880006/S036)St. Jude Medical, Inc.2006-03-02
TENDRILL MODEL 1488T/TC AND 1688T/TC LEADS (P960013/S017)ABBOTT MEDICAL2006-03-02
FRONTIER II DEVICE MODEL 5586 (P030035/S010)ABBOTT MEDICAL2006-03-02
MARQUIS, MAXIMO, INSYNC, ENTRUST, AND INTRINSIC FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P010031/S034)Medtronic Cardiac Rhythm Disease Management2006-03-02
MICRONY PULSE GENERATORS (P970013/S003)ABBOTT MEDICAL2006-03-02
IMPLANTABLE PACEMAKERS (P880086/S113)ABBOTT MEDICAL2006-03-02
TENDRIL MODEL 1488T/TC AND 1688T/TC LEADS (P960013/S016)ABBOTT MEDICAL2006-03-02
EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM (P020009/S024)Boston Scientific Scimed, Inc.2006-03-02
GEM MODEL 7227 IMPLANTABLE DEVICE (P900061/S061)Medtronic Cardiac Rhythm Disease Management2006-02-28
INTRASTENT DOUBLE STRUT STENT (P030045/S001)Medtronic Vascular, Inc.2006-02-28
INSYNC MAQUIS, INSYNC MAXIMO, INSYNC SENTRY AND IMSYNC II MARQUIS IMPLANTABLE DEVICES (P010031/S035)Medtronic Cardiac Rhythm Disease Management2006-02-28
CARELINK MONITORS, MODELS 2490G, 2490H, 2490J (P890003/S099)Medtronic, Inc.2006-02-28
GEM DR, GEM II DR/VR, GEM III DR/VR, ONYX, MARQUIS DR/VR, MAXIMO DR/VR, INTRINSIC, INTRINSIC 30 IMPLANTABLE DEVICES (P980016/S068)Medtronic Cardiac Rhythm Disease Management2006-02-28
LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER ? SAFIRE MODEL (P960016/S014)St Jude Medical2006-02-24
QUICKSITE MODEL 1056K LEAD (P030054/S021)ABBOTT MEDICAL2006-02-24
MEDTRONIC P1501 DR ENRHYTHM IPG SYSTEM (P980035/S053)Medtronic, Inc.2006-02-22
MEDTRONIC ENTRUST MODELS D153ATG, D153DRG,D153VRC,D254ATG,D154DRG,D154VRC (P980016/S065)Medtronic Cardiac Rhythm Disease Management2006-02-22
THE AMPLATZER SEPTAL OCCLUDER (P000039/S015)ABBOTT MEDICAL2006-02-22
PHOTON MICRO, EPIC, ATLAS, EPIC+, AND ATLAS+ FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P910023/S095)ABBOTT MEDICAL2006-02-16
NAVISTAR DIAGNOSTIC ABLATION TIP CATHETER,QWIKSTAR DIAGNOSTIC ABLATION CATHETER (P990025/S010)Biosense Webster, Inc.2006-02-16
NAVISTAR DIAGNOSTIC ABLATION TIP CATHETER, CELSIUS DIAGNOSTIC (P950005/S020)Biosense Webster, Inc.2006-02-16
MARQUIS DR, MARQUIS VR, MAXIMO DR, MAXIMO VR, INTRINSIC 30, INTRINSIC, ENTRUST 30J/35J (P980016/S059)Medtronic Cardiac Rhythm Disease Management2006-02-16
MEDTRONIC KAPPA 400 SERIES PACEMAKER SYSTEMS (P970012/S018)Medtronic, Inc.2006-02-16
MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR SYSTEM (P010031/S029)Medtronic Cardiac Rhythm Disease Management2006-02-16
ST JUDE MEDICAL HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM (P910023/S094)ABBOTT MEDICAL2006-02-16
THERA/PRODIGY (P890003/S092)Medtronic, Inc.2006-02-16
MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW) (P910031/S023)Abbott Vascular Devices2006-02-16
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