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Cardiovascular

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

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RecordFirmDate
TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS (P960013/S059)ABBOTT MEDICAL2010-05-13
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S090)Boston Scientific Corp2010-05-13
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S238)Advanced Cardiovascular Systems, Inc.2010-05-13
EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S001)Boston Scientific Corporation2010-05-13
LUMAX FAMILY OF ICDS AND CRT-DS (P050023/S030)Biotronik, Inc.2010-05-13
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S088)Boston Scientific Corp2010-05-13
PASSIVE PLUS, ISOFLEX S & P, AND ISOFLEX OPTIM LEADS (P960030/S030)ABBOTT MEDICAL2010-05-13
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT (P060008/S051)Boston Scientific Corp2010-05-13
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S052)Boston Scientific Corp2010-05-13
LINOX SD AND LINOX S FAMILY OF ICD PACING LEADS (P980023/S040)Biotronik, Inc.2010-05-13
EXPRESS2 CORONARY STENT SYSTEM (P020009/S063)Boston Scientific Scimed, Inc.2010-05-13
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P060008/S050)Boston Scientific Corp2010-05-13
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S012)Boston Scientific Corp2010-05-13
STEROX S AND DEXTRUS FAMILY OF IMPLANTABLE PACEMAKER PULSE GENERATORS AND PROGRAMMERS (P950037/S080)Biotronik, Inc.2010-05-13
VERIFLEX CORONARY STENT SYSTEM (P040016/S056)Boston Scientific Scimed, Inc.2010-05-13
POWERLINK STENT GRAFT WITH INTUITRAK DELIVERY SYSTEM (P040002/S028)Endologix, LLC2010-05-13
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S089)Boston Scientific Corp2010-05-13
ENTRUST/VIRTUOSO/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS (P980016/S236)Medtronic Cardiac Rhythm Disease Management2010-05-12
POWERLINK SYSTEMWITH INTUITRAK DELIVERY SYSTEM (P040002/S027)Endologix, LLC2010-05-12
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S050)W. L. Gore & Associates, Inc.2010-05-12
BIOGLUE SURGICAL ADHESIVE (P010003/S015)Cryolife, Inc.2010-05-12
ENRHYTHM IPG (P980035/S165)Medtronic, Inc.2010-05-12
DIVA PLATFORM IMPLANTABLE PULSE GENERATORS & PRO VIT APPLICATION SOFTWARE (P990001/S066)Medtronic, Inc.2010-05-12
INSYNC ICD (P010031/S195)Medtronic Cardiac Rhythm Disease Management2010-05-12
MEDTRONIC CARELINK DEVICE DATA MANAGEMENT APPLICATION (DDMA) (P890003/S188)Medtronic, Inc.2010-05-11
MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P850051/S072)Medtronic, Inc.2010-05-11
EPICARDIAL PATCH LEAD & SIZING/UPSIZING SLEEVE (P900061/S087)Medtronic Cardiac Rhythm Disease Management2010-05-11
INSYNC III (IPG) (P010015/S082)Medtronic, Inc.2010-05-11
MEDTRONIC SECURA DR/VR D224DRG/ D224VRC, MAXIMO DR/VR D284DRG/ D284VRC, VIRTUOSO II DR/VR D274DRG/ D274VRC (P980016/S234)Medtronic Cardiac Rhythm Disease Management2010-05-11
LEGEND PLUS FAMILY OF PACEMAKERS (P930022/S011)Medtronic, Inc.2010-05-11
VITATRON (P990001/S064)Medtronic, Inc.2010-05-11
TAXUS LIBERTE OTW & TAXUS LIBERTE ATOM OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S045)Boston Scientific Corp2010-05-11
EXPRESS2 OTW CORONARY STENT SYSTEM (P020009/S061)Boston Scientific Scimed, Inc.2010-05-11
MEDTRONIC CONSULTA CRT-D D224TRK, MAXIMO 2 CRT-D D284TRK, CONCERTO 2 D274TRK IMPLANTSBLE CARDIOVERTER DEFIBRILLATORS (P010031/S193)Medtronic Cardiac Rhythm Disease Management2010-05-11
VERIFLEX OTW BARE-METAL CORONARY STENT SYSTEM (P040016/S054)Boston Scientific Scimed, Inc.2010-05-11
TAXUS EXPRESS2 CORONARY STENT SYSTEM/TAXUS EXPRESS2 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S085)Boston Scientific Corp2010-05-11
INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS (P010031/S191)Medtronic Cardiac Rhythm Disease Management2010-05-11
KAPPA 400 DR/SR IPG (P970012/S065)Medtronic, Inc.2010-05-11
PRODIGY/THERA I IPG (P890003/S186)Medtronic, Inc.2010-05-11
SIGMA/MEDTRONIC 350 SERIES/ENRHYTHM IPG/ADAPTA/SENSIA/RELIA/VERSA (P980035/S161)Medtronic, Inc.2010-05-11
RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS (P980016/S232)Medtronic Cardiac Rhythm Disease Management2010-05-11
QUANTUM MAVERICK OTW/APEX OTW/MAVERICK OTW/MAVERICK XL MONORAIL PTCA DILATATION CATHETERS (P860019/S252)Scimed Life Systems, Inc.2010-05-11
DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR (P820003/S093)Medtronic Cardiac Rhythm Disease Management2010-05-11
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S010)Boston Scientific Corp2010-05-11
CSS-SVC TRANSVENE LEAD (P980050/S047)Medtronic, Inc.2010-05-11
QUICKFLEX U MODEL 1258T LEAD (P030054/S130)ABBOTT MEDICAL2010-05-10
KRONOS LV-T AND LUMAX 300/340 & 500/540 HF/HF-T (P050023/S024)Biotronik, Inc.2010-05-07
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S010)ABBOTT MEDICAL2010-05-07
FORTIFY DR / VR ICD SYSTEMS (P910023/S226)ABBOTT MEDICAL2010-05-07
UNIFY CRT-D SYSTEM (P030054/S141)ABBOTT MEDICAL2010-05-07
EVIA/ENTOVIS PULSE GENERATORS (P070008/S011)Biotronik, Inc.2010-05-07
EVIA / ENTOVIS & VARIOUS OTHER PULSE GENERATORS (P950037/S072)Biotronik, Inc.2010-05-07
EVIA/ENTOVIS PULSE GENERATORS (P000009/S035)Biotronik, Inc.2010-05-07
VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S030)Vascular Solutions, Inc.2010-05-07
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S049)W. L. Gore & Associates, Inc.2010-05-05
PERCLOSE AT 6F SUTURE-MEDIATED CLOSURE SYSTEM & THE PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM (P960043/S071)Abbott Vascular, Inc.2010-05-05
MYNX VASCULAR CLOSURE DEVICE (P040044/S031)Cordis US Corporation2010-05-04
ST JUDE MEDICAL, MERLIN PSA EX3100 SYSTEM (P030054/S146)ABBOTT MEDICAL2010-05-03
RX ACCULINK CAROTID STENT SYSTEM (P040012/S031)Abbott Vascular2010-04-30
HEARTMATE II (P060040/S009)ABBOTT MEDICAL2010-04-30
CONCERTO II/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO CRT-D (P010031/S194)Medtronic Cardiac Rhythm Disease Management2010-04-30
ENTRUST/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VIRTUOSO/VIRTUOSO II VR ICDS (P980016/S235)Medtronic Cardiac Rhythm Disease Management2010-04-30
ENRHYTHM IPG/ADAPTA/VERSA/SENIA IPG/RELIA IPG (P980035/S164)Medtronic, Inc.2010-04-30
LUMAX 540 VR-T DX ICD (P050023/S029)Biotronik, Inc.2010-04-30
TALENT THORACIC GRAFT SYSTEM (P070007/S017)Medtronic Vascular2010-04-30
MYNX VASCULAR CLOSURE DEVICE (P040044/S030)Cordis US Corporation2010-04-30
LUMAX 540 VR-T DX ICDS (P950037/S078)Biotronik, Inc.2010-04-30
TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S015)Medtronic Vascular2010-04-29
SITUS OTW UW28D LEADS (P060027/S022)MicroPort CRM USA, Inc.2010-04-29
SITUS OTW UW28D LEADS (P020030/S006)MicroPort CRM USA, Inc.2010-04-29
MYNX VASCULAR CLOSURE DEVICE (P040044/S029)Cordis US Corporation2010-04-28
CAPSURE/CAPSURE Z NOVUS/STERX TIP PACING LEAD (VENTRICULAR)/VITATRON EXCELLENCE S+/EXCELLENCE SS+/IMPULSE/IMPULSE II (P850089/S065)Medtronic Cardiac Rhythm Disease Management2010-04-28
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S007)Syncardia Systems, LLC2010-04-28
SELECTSECURE (P030036/S016)Medtronic Cardiac Rhythm Disease Management2010-04-28
CONCERTO/II/CONSULTA/INSYNC ICD/MARQUIS/MAXIMO/INSYNC II/MARQUIS/MAXIMO II/INSYNC II PROTECT/III MARQUIS/SENTRY (P010031/S192)Medtronic Cardiac Rhythm Disease Management2010-04-28
IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT/FIDELIS/QUATTRO/SUBCUTANEOUS LEAD/SUB-Q DEFIBRILLAION LEAD/TRANSVENE CS/SVC LEAD (P920015/S059)Medtronic, Inc.2010-04-28
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S049)Medtronic, Inc.2010-04-28
ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN (P900061/S088)Medtronic Cardiac Rhythm Disease Management2010-04-28
CAPSURE/ENTRUST/GEM/II/III/INTRINSIC/MARQUIS/MAXIMO/II/ONYX/SECURA/VIRTUOSO/II (P980016/S233)Medtronic Cardiac Rhythm Disease Management2010-04-28
CLARITY/DA+ C-SERIES/T-SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/SELECTION AFM/TOPAZ 3/II/VITA/2 (P990001/S065)Medtronic, Inc.2010-04-28
350 SERIES/ADAPTA/AT500/ENPULSE/ENRHYTHM/KAPPA 600/700/800/900/RELIA/SENSIA/VERSA/SIGMA (P980035/S163)Medtronic, Inc.2010-04-28
CAPSURE/VITATRON CRYSTALINE/EXCELLENCE+/EXCELLENCE PS+ (P830061/S050)Medtronic Cardiac Rhythm Disease Management2010-04-28
ATTAIN STARFIX (P060039/S011)Medtronic, Inc.2010-04-28
CAPSURE/CAPSURE MODEL/PRODIGY/SERVICE KIT-PACEMAKER REPAIR KIT/THERA-I/VITATRON LEGACY/LEGACY II/VISA (P890003/S187)Medtronic, Inc.2010-04-28
PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S008)Medtronic Vascular, Inc.2010-04-28
CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S+ (P930039/S036)Medtronic, Inc.2010-04-28
KAPPA 400 (P970012/S066)Medtronic, Inc.2010-04-28
CAPSURE EPICARDIAL PACING LEAD (P950024/S020)Medtronic, Inc.2010-04-28
ATTAIN/INSYNC/INSYNC III (P010015/S083)Medtronic, Inc.2010-04-28
ATTAIN (P080006/S007)Medtronic, Inc.2010-04-28
JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD (P980050/S048)Medtronic, Inc.2010-04-28
TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S069)Boston Scientific Corp2010-04-27
OVATIO VR/DR (P980049/S053)MicroPort CRM USA, Inc.2010-04-27
OVATIO CRT-D (P060027/S019)MicroPort CRM USA, Inc.2010-04-27
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S024)Boston Scientific Corp2010-04-27
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P030035/S067)ABBOTT MEDICAL2010-04-23
EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S147)ABBOTT MEDICAL2010-04-23
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S033)Abbott Vascular, Inc.2010-04-23
MULTI-LINK ZETA CORONARY STENT SYSTEMS (CSS) (P970020/S055)Abbott Vascular, Inc.2010-04-23
MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS VISION/MINI VISION (P020047/S018)Abbott Vascular2010-04-23
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