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Cardiovascular

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

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RecordFirmDate
SUTURE SLEEVE ACCESSORY (P010012/S273)Boston Scientific Corp2011-12-23
RF CONTRACTR/RF CONDUCTR/RF MARINR/RF MARINR 5FR/RF ENHANCER II FAMILIES OF ABLATION CATHETERS (P930029/S035)Medtronic, Inc.2011-12-23
CONSULTA CRT-P/SYNCRA CRT-P (P010015/S149)Medtronic, Inc.2011-12-23
CELSIUS RMT THERMOCOOL MAGNETIC CATHETER (P040036/S028)Biosense Webster, Inc.2011-12-23
NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETERS (P030031/S037)Biosense Webster, Inc.2011-12-23
TRIFECTA HEART VALVE (P100029/S003)ABBOTT MEDICAL2011-12-22
ST JUDE MEDICAL BIOCOR/BIOCOR/SUPRA/EPIC/EPIC SUPRA HEART VALVES (P040021/S016)ABBOTT MEDICAL2011-12-22
EPG-SINGLE AND DUAL CHAMBER (P820003/S114)Medtronic Cardiac Rhythm Disease Management2011-12-21
THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D-1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER (P030031/S025)Biosense Webster, Inc.2011-12-21
CARELINK PROGRAMMER CRM PROGRAMMER (P890003/S242)Medtronic, Inc.2011-12-21
THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER (P990071/S009)Biosense Webster, Inc.2011-12-21
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S067)W. L. Gore & Associates, Inc.2011-12-21
THE GORE TAG THORACIC ENDOPROSTHESIS (P040043/S041)W. L. Gore & Associates, Inc.2011-12-21
THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER (P990071/S013)Biosense Webster, Inc.2011-12-21
CARBOMEDICS PROSTHETIC HEART VALVE (P900060/S041)Corcym S.r.l.2011-12-21
HEARTMATE XVE LVAS (P920014/S031)Thoratec Corp2011-12-21
THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER (P030031/S034)Biosense Webster, Inc.2011-12-21
THORATEC VAD SYSTEM (P870072/S046)Thoratec Laboratories Corp.2011-12-21
HEARTMATE II LVAS (P060040/S014)ABBOTT MEDICAL2011-12-21
RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER WITH LUMEN (P020052/S009)St Jude Medical2011-12-20
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S016)Spectranetics Corp.2011-12-20
LIVEWIRE TC AND SAFIRE ABLATION CATHETERS (P960016/S038)St Jude Medical2011-12-20
SPRINT QUATTRO/SUBCUTANEOUS LEAD (P920015/S085)Medtronic, Inc.2011-12-19
CAPSUREFIX MRI (P090013/S048)Medtronic, Inc.2011-12-19
EPIC VALVE (P040021/S019)ABBOTT MEDICAL2011-12-19
CAPSURE (P830061/S074)Medtronic Cardiac Rhythm Disease Management2011-12-19
TRANSVENE CS/SVC LEAD (P980050/S069)Medtronic, Inc.2011-12-19
ADAPTER 2D MATRIX BARCODE VERIFICATION SYSTEM (P110001/S002)Abbott Vascular2011-12-19
CAPSURE (P890003/S241)Medtronic, Inc.2011-12-19
CAPSURE/SUREFIX (P930039/S065)Medtronic, Inc.2011-12-19
CAPSURE EPICARDIAL PACING LEAD (P950024/S039)Medtronic, Inc.2011-12-19
ATTAIN (P010015/S150)Medtronic, Inc.2011-12-19
SELECTSECURE (P030036/S038)Medtronic Cardiac Rhythm Disease Management2011-12-19
MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S041)Cordis US Corporation2011-12-19
ATTAIN STARFIX (P060039/S032)Medtronic, Inc.2011-12-19
ATTAIN ABILITY/ABILITY PLUS/ABILITY STRAIGHT (P080006/S037)Medtronic, Inc.2011-12-19
CAPSURE Z NOVUS (P850089/S086)Medtronic Cardiac Rhythm Disease Management2011-12-19
CARDIOGENESIS TMR SYSTEM (P970029/S018)Cryolife, Inc.2011-12-16
ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) & OTW (P100023/S003)Boston Scientific Corp2011-12-15
PROMUS ELEMENT PLUS PLATINUM CHROMIUM EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S002)Boston Scientific Corp2011-12-14
ATRICURE SYNERGY ABLATION SYSTEM (P100046)AtriCure, Inc.2011-12-14
PROTECTA & PROTECTA XT (P010031/S283)Medtronic Cardiac Rhythm Disease Management2011-12-14
PROTECTA AND PROTECTA XT (P980016/S330)Medtronic Cardiac Rhythm Disease Management2011-12-14
ION PLATINUM CHROMIUM PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S029)Boston Scientific Corp2011-12-14
ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S041)Cook, Inc.2011-12-14
3F AORTIC BIOPROSTHESIS (P060025/S008)Medtronic, Inc.2011-12-13
MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II (P980016/S328)Medtronic Cardiac Rhythm Disease Management2011-12-13
CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT (P010031/S281)Medtronic Cardiac Rhythm Disease Management2011-12-13
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S023)Boston Scientific Corp2011-12-13
ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA (P980035/S250)Medtronic, Inc.2011-12-13
REVO MRI (P090013/S045)Medtronic, Inc.2011-12-13
CONSULTA CRT-P & SYNCRA CRT-P (P010015/S146)Medtronic, Inc.2011-12-13
RX ACCULINK CARTOID STENT SYSTEM (P040012/S043)Abbott Vascular2011-12-13
PARADYM VR & DR (P980049/S067)MicroPort CRM USA, Inc.2011-12-12
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S040)Edwards Lifesciences, LLC2011-12-12
EDWARDS PRIMA PLUS PROCINE STENTLESS BIOPROSTHESTIC VALVES (P010041/S028)Edwards Lifesciences, LLC2011-12-12
PARADYM CRT (P060027/S034)MicroPort CRM USA, Inc.2011-12-12
EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES (P000007/S027)Edwards Lifesciences, LLC2011-12-12
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHETIV VALVES (P860057/S081)Edwards Lifesciences, LLC2011-12-12
MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S010)Corcym Canada Corp2011-12-12
NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETERS (P030031/S036)Biosense Webster, Inc.2011-12-12
CELSIUS RMT THERMOCOOL MAGNETIC CATHETER (P040036/S027)Biosense Webster, Inc.2011-12-12
CAPENTIER-EDWARDS PORCINE BIOPRSTHETIC (P870056/S044)Edwards Lifesciences, LLC2011-12-12
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S028)Boston Scientific Corp2011-12-07
CORONARY FLEXTOME CUTTING BALLOON (P950020/S047)Boston Scientific Corp2011-12-07
MODEL 2090 MEDTRONIC/VITATRON CARELINK PROGRAMMER (P890003/S239)Medtronic, Inc.2011-12-07
ASSURANT COBALT BALLOON LLIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S001)Medtronic, Ireland2011-12-07
XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P110019/S004)Abbott Vascular2011-12-07
BARD E-LUMINEXX VASCULAR STENT (P080007/S010)Bard Peripheral Vascular, Inc.2011-12-07
ADVISA & ENRHYTHM (P980035/S249)Medtronic, Inc.2011-12-06
SPECTRANETICS EXCIMER LASER (P910001/S050)Spectranetics Corp.2011-12-06
REVO MRI (P090013/S044)Medtronic, Inc.2011-12-06
CONSULTA CRT-P & SYNCRA CRT-P (P010015/S145)Medtronic, Inc.2011-12-06
AFX ENDOVASCULAR AAA SYSTEM (P040002/S035)Endologix, LLC2011-12-06
CONCERT II/CONSULTA/INSYNC II/III MARQUIS/MAXIMO/SENTRY/MAXIMO II PROTECTA/XT/INSYNC MARQUIS/INSYNC II PROTECT/CONCERTO (P010031/S280)Medtronic Cardiac Rhythm Disease Management2011-12-06
ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II SECURA/VIRTUOSO II/INSYNC MARQUIS/VIRTUOSO/PROTECTA (P980016/S327)Medtronic Cardiac Rhythm Disease Management2011-12-06
ZENITH TX2 TAA ENDOVASCULAR GRAFT (P070016/S006)William Cook Europe Aps2011-12-06
MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR/MODEL 2020A MEDTRONIC CARDIOSIGHT READER/MODEL 2020B CARELINK EXPRES (P890003/S238)Medtronic, Inc.2011-12-06
FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM (P100028/S001)Cook Medical Incorporated2011-12-05
EXPRESS 2 MONORAIL AND OVER-THE-WIRE (P020009/S080)Boston Scientific Scimed, Inc.2011-12-05
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S082)Boston Scientific Corp2011-12-05
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDWIRE WITH WIRECLIP TORQUER (P900056/S110)Boston Scientific Corp2011-12-05
CHILLI II COOLED ABLATION CATHETER & CABLE (P980003/S033)Boston Scientific Corp2011-12-05
EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S022)Boston Scientific Corp2011-12-05
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S082)Boston Scientific Scimed, Inc.2011-12-05
S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S021)Cordis US Corporation2011-12-05
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S111)Boston Scientific Corp2011-12-05
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S094)Boston Scientific Corp2011-12-05
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S027)Boston Scientific Corp2011-12-05
BLAZER II CARDIAC ABLATION CATHETER & CABLE (P920047/S050)Boston Scientific Corp2011-12-05
BLAZER II XP CARDIAC ABLATION CATHETER & CABLE (P020025/S032)Boston Scientific2011-12-05
RENEWAL TR CRT-P DEVICES (P030005/S080)Guidant Corp.2011-12-05
VARIOUS FAMILIES/MODELS OF TILDA BRADYCARDIA PACING LEADS (P950037/S099)Biotronik, Inc.2011-12-02
VARIOUS FAMILIES/MODELS OF CELERITY CRT PACING LEADS (P070008/S027)Biotronik, Inc.2011-12-02
UNIFY FAMILY OF CRT-DS (P030054/S207)ABBOTT MEDICAL2011-12-01
FORTIFY FAMILY OF ICDS (P910023/S280)ABBOTT MEDICAL2011-12-01
CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT (P010031/S279)Medtronic Cardiac Rhythm Disease Management2011-11-30
PARADYM CRT-D (P060027/S033)MicroPort CRM USA, Inc.2011-11-30
PARADYM VR & DR (P980049/S066)MicroPort CRM USA, Inc.2011-11-30
MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II (P980016/S326)Medtronic Cardiac Rhythm Disease Management2011-11-30
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