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Cardiovascular

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

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RecordFirmDate
CONFIENT (P960040/S231)Boston Scientific2010-09-14
GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S109)Medtronic, Ireland2010-09-14
INTEGRITY CORONARY STENT SYSTEM (P030009/S039)Medtronic, Ireland2010-09-14
LIVIAN & RENEWAL 3 PULSE GENERATORS (P010012/S251)Boston Scientific Corp2010-09-14
BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S013)Bard Peripheral Vascular, Inc.2010-09-14
VIGOR DR/SR PACEMAKER SYSTEM (P940031/S069)Boston Scientific2010-09-14
DELTA PACEMAKER SYSTEM (P840068/S047)Boston Scientific2010-09-14
VENTAK PRX AICD SYSTEM (P910077/S108)Boston Scientific2010-09-14
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S011)ABBOTT MEDICAL2010-09-13
PHILOS DR/SR & PHILOS II DR/SR (P950037/S085)Biotronik, Inc.2010-09-10
LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S032)St Jude Medical2010-09-10
RIATA ST OPTIM AND RIATA STS OPTIM LEADS (P950022/S073)ABBOTT MEDICAL2010-09-09
ADAPTA/VERSA/SENSIA/RELIA IPGS (P980035/S186)Medtronic, Inc.2010-09-09
PARADYM IMPLANT SOFTWARE VERSION W2.8.4, AND ASSOCIATED PROGRAMMER SOFTWARE SMARTVIEW 2.22UG1 (P980049/S059)MicroPort CRM USA, Inc.2010-09-09
PARADYM IMPLANT SOFTWARE VERSION W2.8.4, AND ASSOCIATED PROGRAMMER SOFTWARE SMARTVIEW 2.22UG1 (P060027/S026)MicroPort CRM USA, Inc.2010-09-09
CURRENT + DEVICES & CURRENT ACCEL DEVICES (P030054/S162)ABBOTT MEDICAL2010-09-09
PROMOTE DEVICES & PROMOTE ACCEL DEVICES (P910023/S243)ABBOTT MEDICAL2010-09-09
MOSAIC BIOPROSTHESIS (P990064/S034)Medtronic, Inc.2010-09-08
BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S015)Bard Peripheral Vascular2010-09-08
INSYNC III CRT-P (P010015/S099)Medtronic, Inc.2010-09-08
DEMA IPGS/ C & T SERIES IPGS (P990001/S076)Medtronic, Inc.2010-09-08
BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S016)Bard Peripheral Vascular2010-09-08
COGNIS (P010012/S250)Boston Scientific Corp2010-09-08
GORE VIABAHN ENDOPROSTHESIS (P040037/S028)W. L. Gore & Associates, Inc.2010-09-08
RELIANCE ENDOTAK IMPLANTABLE LEADS (P910073/S086)Boston Scientific2010-09-08
PARADYM ICDS AND CRT-D DEVICES (P060027/S028)MicroPort CRM USA, Inc.2010-09-08
APEX PTCA & NC QUANTUM APEX PTCA CATHETERS (P860019/S263)Scimed Life Systems, Inc.2010-09-08
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S010)Spectranetics Corp.2010-09-08
MAVERICK2 MONORAIL PTCA DILATATION CATHETER (P860019/S261)Scimed Life Systems, Inc.2010-09-08
SIGMA/MEDTRONIC 350/ENRHYTHM/AT500 IPGS (P980035/S187)Medtronic, Inc.2010-09-08
TELIGEN (P960040/S230)Boston Scientific2010-09-08
BARD ELUMINEXX VASCULAR STENT (P080007/S004)Bard Peripheral Vascular, Inc.2010-09-08
PARADYM ICDS AND CRT-D DEVICES (P980049/S060)MicroPort CRM USA, Inc.2010-09-08
COGNIS (P010012/S237)Boston Scientific Corp2010-09-07
ETHICON OMNEX SURGICAL SEALANT APPLICATOR AND PACKAGING (P060029/S001)ETHICON, Inc.2010-09-07
TELIGEN (P960040/S218)Boston Scientific2010-09-07
IMPLANTABLE PULSE GENERATOR, PACEMAKER (P010012/S248)Boston Scientific Corp2010-09-03
H120 & H125 CONTAK RENEWAL TR IS-1 (P030005/S068)Guidant Corp.2010-09-03
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM (P960040/S228)Boston Scientific2010-09-03
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S078)Cordis Corp.2010-09-02
IMPLANTABLE PULSE GENERATOR, PACEMAKER (P010012/S249)Boston Scientific Corp2010-09-02
PRECISE OTW/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEM (P030047/S022)Cordis US Corporation2010-09-02
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM (P960040/S229)Boston Scientific2010-09-02
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S044)Abbott Vascular, Inc.2010-09-02
SMART NITINOL STENT & SMART CONTROL NITINOL STENT SYSTEMS (P020036/S019)Cordis US Corporation2010-09-02
RELIATY/MODEL 3145 PACING SYSTEM ANALYZER (P950037/S079)Biotronik, Inc.2010-09-02
SPECTRANETICS LASER SHEATH II PRODUCTS (P960042/S019)Spectranetics (Philips)2010-09-01
VERIFLEX (LIBERTE) STENT DELIVERY SYSTEM (P040016/S062)Boston Scientific Scimed, Inc.2010-09-01
ENDEAVOR ZOTAROLIMUS-ELUTING STENT SYSTEM (P060033/S057)Medtronic, Inc.2010-09-01
GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S022)W. L. Gore & Associates, Inc.2010-09-01
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S058)Boston Scientific Corp2010-09-01
EXPRESS SD PREMOUNTED STENT SYSTEM (P060006/S015)Boston Scientific Corp2010-09-01
PTCA CATHETERS (MAVERICK2/MAVERICK/MAVERICK XL/QUANTUM/MAVERICK/APEX) (P860019/S260)Scimed Life Systems, Inc.2010-09-01
LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S022)Zoll Manufacturing Corporation2010-09-01
GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S021)W. L. Gore & Associates, Inc.2010-09-01
MULTI-LINK 8 SMALL VESSEL CORONARY STENT SYSTEM (P020047/S022)Abbott Vascular2010-08-31
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S043)Abbott Vascular, Inc.2010-08-27
KAPPA 400 DR/SR IPG (P970012/S074)Medtronic, Inc.2010-08-27
INSYNC CRT-P & INSYNC III CRT-P (P010015/S098)Medtronic, Inc.2010-08-27
EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S166)ABBOTT MEDICAL2010-08-27
SMART/SMART CONTROL NITINOL STENT SYSTEMS (P020036/S018)Cordis US Corporation2010-08-27
CAPSURE PACING LEAD (P930039/S043)Medtronic, Inc.2010-08-27
KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S184)Medtronic, Inc.2010-08-27
DEMA IPG/C & T SERIES (P990001/S075)Medtronic, Inc.2010-08-27
ADAPTA/VERSA/SENSIA/RELIA (P980035/S185)Medtronic, Inc.2010-08-27
INSYNC/INSYNC MARQUIS/II/III/INSYNC II PROTECT/SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS (P010031/S214)Medtronic Cardiac Rhythm Disease Management2010-08-27
CADENCE FAMILY OF ICDS (P910023/S247)ABBOTT MEDICAL2010-08-27
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S063)Terumo Medical Corporation2010-08-27
PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENTS SYSTEMS (P030047/S021)Cordis US Corporation2010-08-27
GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR SECURA DR/VR ICDS (P980016/S258)Medtronic Cardiac Rhythm Disease Management2010-08-27
CONCERTO/CONSULTA/MAXIMO II/ CONCERTO II CRT-DS (P010031/S213)Medtronic Cardiac Rhythm Disease Management2010-08-26
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S042)Abbott Vascular, Inc.2010-08-26
BLAZER II/BLAZER PRIME HTD ABLATION CATHETERS (P920047/S043)Boston Scientific Corp2010-08-26
VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS (P980016/S257)Medtronic Cardiac Rhythm Disease Management2010-08-26
BLAZER II XP/BLAZER PRIME XP ABLATION CATHETERS (P020025/S024)Boston Scientific2010-08-26
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK ADVANCER (P900056/S102)Boston Scientific Corp2010-08-26
C & T SERIES IPG (P990001/S074)Medtronic, Inc.2010-08-25
ENRHYTHM IPG (P980035/S183)Medtronic, Inc.2010-08-25
SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO ICDS (P980016/S256)Medtronic Cardiac Rhythm Disease Management2010-08-20
LUMAX FAMILIES OF ICDS & CRT-DS (P050023/S036)Biotronik, Inc.2010-08-20
INSYNC SENTRY/III MARQUIS/II MARQUIS/MAXIMO/CONCERTO ICDS/CONSULTA/MAXIMO II/CONCERTO II CRT-DS (P010031/S212)Medtronic Cardiac Rhythm Disease Management2010-08-20
REPLY DR/SR & REPLY DR/SR (V2)/ESPRIT DR/SR (P950029/S054)MicroPort CRM USA, Inc.2010-08-18
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) (P820003/S098)Medtronic Cardiac Rhythm Disease Management2010-08-18
ENPULSE/KAPPA 700/800/900/ADAPTA/SIGMA/RELIA/SENSIA/VERSA (P980035/S179)Medtronic, Inc.2010-08-13
CONTAK CD/EASYTRAK/LIVIAN/COGNIS/ACUITY SPIRAL (P010012/S246)Boston Scientific Corp2010-08-13
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S004)Boston Scientific Corp2010-08-13
ECG CABLE/CAPSURE VDD LEADS/VITATRON BRILLANT S+ VDD LEADS/VITATRON LEGACY/LEGACY II/VISA (P890003/S196)Medtronic, Inc.2010-08-13
ACCESSORY (UPSIZING SLEEVE)/ LEAD END PIN CAP (P900061/S093)Medtronic Cardiac Rhythm Disease Management2010-08-13
BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S014)Bard Peripheral Vascular2010-08-13
CS-SVC TRANSVENE LEAD (P980050/S052)Medtronic, Inc.2010-08-13
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S061)Boston Scientific Scimed, Inc.2010-08-13
DA+ C-SERIES & DA+ T-SERIES (P990001/S073)Medtronic, Inc.2010-08-13
DISPOSABLE COVER (P820003/S096)Medtronic Cardiac Rhythm Disease Management2010-08-13
CAPSUREFIX/CAPSUREFIX NOVUS/SUREFIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S (P930039/S042)Medtronic, Inc.2010-08-13
CAPSURE VDD LEADS/WRENCH KIT/VITATRON BRILLANT S+ VDD LEADS (P890003/S197)Medtronic, Inc.2010-08-13
CADENCE/CURRENT FAMILY OF ICDS (P910023/S245)ABBOTT MEDICAL2010-08-13
ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN CAP (P900061/S094)Medtronic Cardiac Rhythm Disease Management2010-08-13
LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S030)St Jude Medical2010-08-13
ATTAIN/INSYNC/INSYNC III (P010015/S096)Medtronic, Inc.2010-08-13
CAPSURE FIX LEAD/MAXIMO/MARQUIS/INTRINSIC/ENTRUST/VIRTUOSO (P980016/S253)Medtronic Cardiac Rhythm Disease Management2010-08-13
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