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Cardiovascular

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

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RecordFirmDate
COMPLETE SE VASCULAR STENT SYSTEM (P090006/S006)Medtronic Vascular2011-05-17
VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S004)Medtronic Vascular2011-05-17
TORAY INOUE BALLOON CATHETER (P910054/S005)Toray Industries (America), Inc.2011-05-17
VENTAK AV ACID SYSTEM (P960040/S242)Boston Scientific2011-05-17
CONTAK RENEWAL TR CRT-P SYSTEM (P030005/S073)Guidant Corp.2011-05-17
ZENITH AAA ENDOVASCULAR GRAFT (P020018/S038)Cook, Inc.2011-05-17
DELTA PACEMAKER SYSTEM (P840068/S048)Boston Scientific2011-05-17
VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S002)Medtronic Vascular2011-05-17
ENDURANT STENT GRAFT SYSTEM (P100021/S008)Medtronic Vascular2011-05-17
TRIFECTA VALVE (P100029/S001)ABBOTT MEDICAL2011-05-16
ADVISA DR (P980035/S216)Medtronic, Inc.2011-05-13
INSYNC CRT-P/INSYNC III CRT-P (P010015/S107)Medtronic, Inc.2011-05-13
MEDTRONICS CARELINK HOME MONITOR AND CARDIOSIGHT READER (P890003/S211)Medtronic, Inc.2011-05-13
KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S200)Medtronic, Inc.2011-05-13
PROTECTA DR/VR/XT DR/VR (P980016/S293)Medtronic Cardiac Rhythm Disease Management2011-05-13
CONSULTA/SYNCRA CRT-P (P010015/S116)Medtronic, Inc.2011-05-13
CONCERTO II/MAXIMO II/CONSULTA CRT-DS (P010031/S228)Medtronic Cardiac Rhythm Disease Management2011-05-13
DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR (P820003/S104)Medtronic Cardiac Rhythm Disease Management2011-05-13
MEDTRONIC CARELINK PROGRAMMER (P850051/S074)Medtronic, Inc.2011-05-13
PROTECTA/PROTECTA XT CRT-D (P010031/S247)Medtronic Cardiac Rhythm Disease Management2011-05-13
SUBCUTANEOUS LEAD SYSTEM, TRANSVENE SVC LEAD (P920015/S056)Medtronic, Inc.2011-05-13
VIRTUOSO II/SECURA/MAXIMO II ICDS (P980016/S273)Medtronic Cardiac Rhythm Disease Management2011-05-13
TRANSVENE CS/SVC LEAD (P980050/S043)Medtronic, Inc.2011-05-13
PROTECTA DR/VR/XT DR/VR (P980016/S294)Medtronic Cardiac Rhythm Disease Management2011-05-13
CONSULTA & SYNCRA CRT-P (P010015/S117)Medtronic, Inc.2011-05-13
LEGEND PLUS FAMILY OF PACEMAKERS (P930022/S012)Medtronic, Inc.2011-05-13
PROTECTA & PROTECTA XT CRT-DS (P010031/S248)Medtronic Cardiac Rhythm Disease Management2011-05-13
ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR (P900061/S098)Medtronic Cardiac Rhythm Disease Management2011-05-13
TRANSVENE CS/SVC LEAD (P980050/S057)Medtronic, Inc.2011-05-13
DEMA IPG/C & T SERIES IPGS (P990001/S082)Medtronic, Inc.2011-05-13
KAPPA 400 DR/SR IPGS (P970012/S081)Medtronic, Inc.2011-05-13
ZETA RX/ULTRA RX/OTW (P970020/S063)Abbott Vascular, Inc.2011-05-12
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S065)Medtronic, Inc.2011-05-12
TRANSVENE SVC LEAD MODEL 6937/SUBCUTANEOUS LEAD MODEL 6996SQ & VARIOUS ACCESSORIES (P920015/S075)Medtronic, Inc.2011-05-12
XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S068)Abbott Vascular, Inc.2011-05-12
ANCHORING SLEEVE KIT (P030036/S028)Medtronic Cardiac Rhythm Disease Management2011-05-12
ANGIOSCULPT PTCA SCORING BALLOON CATHETER,RAPID EXCHANGE (RX0 (P050018/S014)Spectranetics Corp.2011-05-12
CAPSURE EPI UNIPOLAR/BIPOLAR LEAD (P950024/S030)Medtronic, Inc.2011-05-12
TRANSVENE CS/SVC LEAD (P980050/S060)Medtronic, Inc.2011-05-12
XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S069)Abbott Vascular, Inc.2011-05-12
DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S055)Medtronic, Ireland2011-05-12
VISION RX/OTW/MINI VISION RX/OTW/MULTI LINK 8 OTW (P020047/S034)Abbott Vascular2011-05-12
TRANSVENE EPICARDIAL LEAD (P900061/S101)Medtronic Cardiac Rhythm Disease Management2011-05-12
PASSIVE PLUS/ISOFLEX S/P/OPTIM (P960030/S028)ABBOTT MEDICAL2011-05-11
ST JUDE MEDICAL ICDS & CRT-DS (P030054/S187)ABBOTT MEDICAL2011-05-11
FRONTIER/FRONTIER II/ANTHEM/AESCULA (P030035/S064)ABBOTT MEDICAL2011-05-11
QUICKSITE/QUICKFLEX/EPIC HF/+HF/II HF/II +HF/ATLAS HF/ATLAS + HF/ATLAS II HF/ATLAS II + HF/PROMOTE/PROMOTE + (P030054/S142)ABBOTT MEDICAL2011-05-11
ADDVENT/AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY/ZEPHYR/ACCENT/TRILOGY/SYNCHRONY/PARAGONPHOENIX (P880086/S183)ABBOTT MEDICAL2011-05-11
CADENCE/CADET/CONTOUR/II/MD/ATLAS II/MD/+/PROFILE II/MD/PHOTON/PHOTON MICRO/CURRENT/+/EPIC II/+/CONVERT (P910023/S227)ABBOTT MEDICAL2011-05-11
ST JUDE MEDICAL ICDS & CRT-DS (P910023/S262)ABBOTT MEDICAL2011-05-11
RIATA/RIATA ST/RIATA ST OPTIM/DURATA (P950022/S067)ABBOTT MEDICAL2011-05-11
CRT LEADS (MODELS 1156T, 1158Y AND 1258T). (P030054/S182)ABBOTT MEDICAL2011-05-11
TENDRIL/TENDRIL ST & STS/OPTISENSE (P960013/S055)ABBOTT MEDICAL2011-05-11
FAMILY OF PACEMAKERS (P030035/S079)ABBOTT MEDICAL2011-05-10
FAMILY OF CRT-DS (P030054/S183)ABBOTT MEDICAL2011-05-10
FAMILY OF CRT-PS (P880086/S199)ABBOTT MEDICAL2011-05-10
FAMILY OF ICDS (P910023/S258)ABBOTT MEDICAL2011-05-10
MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM (P100021/S002)Medtronic Vascular2011-05-09
AFX ENDOVASCULAR AAA SYSTEM (P040002/S031)Endologix, LLC2011-05-06
LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX (P050023/S044)Biotronik, Inc.2011-05-06
RX ACCULINK CAROTID STENT SYSTEM (P040012/S034)Abbott Vascular2011-05-06
EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO (P950037/S095)Biotronik, Inc.2011-05-06
ANCHORING SLEEVE KIT (P030036/S022)Medtronic Cardiac Rhythm Disease Management2011-05-05
CADENCE FAMILY OF ICDS (P910023/S260)ABBOTT MEDICAL2011-05-05
REPEL-CV (P070005/S002)Pathfinder Cell Therapy, Inc.2011-05-05
CONTAK RENEWAL TR (P030005/S075)Guidant Corp.2011-05-05
ISOFLEX MODEL 1646T & MODEL 1948T (OPTIM) LOW VOLTAGE LEADS (P960030/S033)ABBOTT MEDICAL2011-05-05
PROTECTA XT/PROTECTA DEVICES (P010031/S245)Medtronic Cardiac Rhythm Disease Management2011-05-05
CARPENTIER-EDWARDS PORCINE AORTIC/PORCINE MITRAL BIOPROSTHESIS (P870056/S043)Edwards Lifesciences, LLC2011-05-05
EPIC HF/ATLAS+HF FAMILY OF CRT-DS (P030054/S185)ABBOTT MEDICAL2011-05-05
SYNCRA CRT-P/CONSULTA CRT-P (P010015/S113)Medtronic, Inc.2011-05-05
ADVISA DR (P980035/S215)Medtronic, Inc.2011-05-05
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S027)Edwards Lifesciences, LLC2011-05-05
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S039)Edwards Lifesciences, LLC2011-05-05
REVO MRI (P090013/S015)Medtronic, Inc.2011-05-05
PROTECTA/PROTECTA XT CRT-DS (P010031/S246)Medtronic Cardiac Rhythm Disease Management2011-05-05
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL/RSR/MAGNA/MAGNA EASE/MITRAL/MAGNA MITRAL AORTIC PERICARDIAL BIOPROSTHESIS (P860057/S078)Edwards Lifesciences, LLC2011-05-05
ADVISA DR (P980035/S213)Medtronic, Inc.2011-05-05
PROTECTA DR/VR/XT DR/VR (P980016/S292)Medtronic Cardiac Rhythm Disease Management2011-05-05
ATTAIN ABILITY PLUS MODEL 4296 (P080006/S022)Medtronic, Inc.2011-05-05
PROTECTA CRT-D/PROTECTA XT CRT-D (P010031/S243)Medtronic Cardiac Rhythm Disease Management2011-05-05
PROTECTA DR/VR/XT DR/XT VR (P980016/S290)Medtronic Cardiac Rhythm Disease Management2011-05-05
PROTECTA DR/VR/XT DR/XT VR (P980016/S289)Medtronic Cardiac Rhythm Disease Management2011-05-05
CONSULTA/SYNCRA CRT-PS (P010015/S114)Medtronic, Inc.2011-05-05
CONSULTA/SYNCRA CRT-P (P010015/S115)Medtronic, Inc.2011-05-05
PROTECTA DR/VR/XT DR/VR (P980016/S291)Medtronic Cardiac Rhythm Disease Management2011-05-05
PROTECTA/PROTECTA XT CRT-DS (P010031/S244)Medtronic Cardiac Rhythm Disease Management2011-05-05
ADVISA DR (P980035/S214)Medtronic, Inc.2011-05-05
EXPRESS & EXPRESS 2 CORONARY STENT SYSTEMS (P020009/S073)Boston Scientific Scimed, Inc.2011-05-04
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P060008/S069)Boston Scientific Corp2011-05-04
XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S067)Abbott Vascular, Inc.2011-05-04
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S020)Boston Scientific Corp2011-05-04
VERIFLEX (LIBERTE) CORONARY STENT SYSTEMS (P040016/S071)Boston Scientific Scimed, Inc.2011-05-04
CARELINK HOME MONITOR AND CARDIOSIGHT MONITOR (P890003/S209)Medtronic, Inc.2011-05-04
RELIANCE LEADS (P910073/S093)Boston Scientific2011-05-03
FAMILY OF CRT-DS (P030054/S186)ABBOTT MEDICAL2011-05-03
FAMILY OF ICDS (P910023/S261)ABBOTT MEDICAL2011-05-03
FAMILY OF CRT-PS (P880086/S201)ABBOTT MEDICAL2011-05-03
FAMILY OF PACEMAKERS (P030035/S081)ABBOTT MEDICAL2011-05-03
VALIANT THORACIC STENT GRAFT SYSTEM (P100040/S001)Medtronic Vascular2011-05-02
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Every clearance here is in the API, with alerts when new ones post.