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Cardiovascular

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

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RecordFirmDate
CAPSURE FIX LEAD (P980016/S172)Medtronic Cardiac Rhythm Disease Management2009-01-09
GORE VIABAHN ENDOPROSTHESIS (P040037/S014)W. L. Gore & Associates, Inc.2009-01-09
CAPSURE EPI UNIPOLAR/BIPOLAR LEADS (P950024/S015)Medtronic, Inc.2009-01-09
PRODIGY IPG/KAPPA 400DR/SR/KAPPA 600/700/650/800/900/SIGMA/MEDTRONIC 350/RELIA/ENPULSE II/AT500/ADAPTA/VERSA/SENSIA (P980035/S125)Medtronic, Inc.2009-01-09
DEMA FAMILY/C-SERIES/T-SERIES (P990001/S048)Medtronic, Inc.2009-01-09
ATTAIN SD (P010031/S139)Medtronic Cardiac Rhythm Disease Management2009-01-09
EPICARDIAL TRANSVENE/CABLE/ACE HEADER/UPSIZING SLEEVE FOR HV LEAD DF-1/UPSIZING SLEEVE/LEAD END PIN CAP (P900061/S081)Medtronic Cardiac Rhythm Disease Management2009-01-09
CAPSURE Z NOVUS/CAPSURE Z/CAPSURE SP/ CAPSURE SP NOVUS LEADS (P850089/S060)Medtronic Cardiac Rhythm Disease Management2009-01-09
LEAD/Y ADAPTORS/IS-1 PORT PIN PLUG/SPRINT LEAD/QUATTRO/QUATTRO SECURE/QUATTRO SINGLE COIL/TRANSVENE SVC/DF-1/Y ADAPTOR (P920015/S051)Medtronic, Inc.2009-01-09
MARQUIS ICD/MAXIMO/MAXIMO II/INTRINSIC/ENTRUST/VIRTUOSO/SECURA ICD FAMILIES (P980016/S171)Medtronic Cardiac Rhythm Disease Management2009-01-09
ATTAIN OTW/BIPOLAR OTW/CS/LV LEADS (P010015/S059)Medtronic, Inc.2009-01-09
MYNX VASCULAR CLOSURE DEVICE (P040044/S010)Cordis US Corporation2009-01-08
AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S007)ABBOTT MEDICAL2009-01-08
HEARTMATE II LVAS (P060040/S003)ABBOTT MEDICAL2009-01-08
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S021)Medtronic, Inc.2009-01-08
AMPLATZER SEPTAL OCCLUDER, AND AMPLATZER ¿CRIBRIFORM¿ OCCLUDER (P000039/S027)ABBOTT MEDICAL2009-01-08
VARIOUS FAMILIS OF ICDS (P980016/S140)Medtronic Cardiac Rhythm Disease Management2009-01-06
INSYNC FAMILIES OF ICD & CONCERTO ICD & CONSULTA CRT-D & MAXIMO II CRT-D (P010031/S109)Medtronic Cardiac Rhythm Disease Management2009-01-06
LINOX SD 60/16 STEROID-ELUTING, ACTIVE FIXATION ICD LEAD (P980023/S037)Biotronik, Inc.2009-01-05
CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS (P010041/S019)Edwards Lifesciences, LLC2008-12-31
CYLOS/PROTOS/AXIOS/PHILOS II & PHILOS/PHILOS DR-T PULSE GENERATORS (P950037/S063)Biotronik, Inc.2008-12-31
STRATOS LV (T) PULSE GENERATOR (P070008/S006)Biotronik, Inc.2008-12-31
DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM (P030009/S030)Medtronic, Ireland2008-12-31
CAEPENTIER EDWARDS PORCINE BIOPROSTHESIS & CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT (P870056/S032)Edwards Lifesciences, LLC2008-12-31
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S020)Edwards Lifesciences, LLC2008-12-31
CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS (P870077/S031)Edwards Lifesciences, LLC2008-12-31
TENDRIL ST LEAD (P960013/S041)ABBOTT MEDICAL2008-12-31
TMR HOLMIUM LASER SYSTEM (P970029/S013)Cryolife, Inc.2008-12-30
C-SERIES & T-SERIES (P990001/S047)Medtronic, Inc.2008-12-24
GRUNTZIG DILACA BALLOON DILATATION CATHETERS (P790017/S098)Medtronic, Ireland2008-12-24
KAPPA 600/650/700/800/900/ENPULSE/ADAPTA/VERSA/SENSIA/RELIA IPGS (P980035/S124)Medtronic, Inc.2008-12-24
KAPPA 400 DR/SR (P970012/S040)Medtronic, Inc.2008-12-24
LUMOS & TACHOS & BELOS FAMILY OF ICDS & XELOS DR-T (P000009/S029)Biotronik, Inc.2008-12-24
TUPOS LV/ATX, KRONOS LV-T, LUMAX 300/340 FAMILY OF ICDS AND CRT-DS (P050023/S015)Biotronik, Inc.2008-12-24
KAPPA 400 DR/SR IPG (P970012/S048)Medtronic, Inc.2008-12-24
INSYNC & INSYNC III (P010015/S050)Medtronic, Inc.2008-12-24
NAVISTAR THERMOCOOL & CELSIUS THERMOCOOL DIAGNOSTIC/ABLATION CATHETERS (P030031/S013)Biosense Webster, Inc.2008-12-24
INSYNC SENTRY/MAXIMO CRT-D/INSYNC II PROTECT & MARQUIS/CONCERTO ICD (P010031/S136)Medtronic Cardiac Rhythm Disease Management2008-12-24
PRECISE NITINOL STENT SYSTEM/PRECISE RX NITINOL STENT SYSTEM/PRECISE PRO RX NITINOL STENT SYSTEM (P030047/S016)Cordis US Corporation2008-12-24
MARQUIS DR/VR/MAXIMO DR/VR/INTRINSIC/ENTRUST/VIRTUOSO ICDS (P980016/S169)Medtronic Cardiac Rhythm Disease Management2008-12-24
KAPPA 600/700/650/800/900 IPG & ENPULSE/ENRHYTHM/ADAPTA/VERSA/SENSIA IPG (P980035/S123)Medtronic, Inc.2008-12-24
VARIOUS FAMILIES OF PACEMAKERS (P990001/S041)Medtronic, Inc.2008-12-24
DRIVER AND MICRODRIVER CORONARY STENT SYSTEMS (P030009/S028)Medtronic, Ireland2008-12-24
VARIOUS FAMILIES OF PACEMAKERS (P980035/S109)Medtronic, Inc.2008-12-24
CURRENT RF AND PROMOTE RF FAMILY OF DEVICES (P910023/S195)ABBOTT MEDICAL2008-12-23
CURRENT RF AND PROMOTE RF FAMILY OF DEVICES (P030054/S110)ABBOTT MEDICAL2008-12-23
CONTAK RENEWAL RF FAMILY (P010012/S198)Boston Scientific Corp2008-12-22
CADENCE ICD SYSTEM (P910023/S197)ABBOTT MEDICAL2008-12-19
EPIC HF CRT-D SYSTEM (P030054/S111)ABBOTT MEDICAL2008-12-19
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S026)W. L. Gore & Associates, Inc.2008-12-19
ZENITH FLEX AAA ENDOVASCULAR GRAFT, ZENITH RENU AAA ANCILLARY GRAFT (P020018/S030)Cook, Inc.2008-12-19
CADENCE FAMILY OF ICDS (P910023/S189)ABBOTT MEDICAL2008-12-18
ATLAS II HF, ATLAS+ HF, ATLAS II+ HF, EPIC HF, EPIC II HF, EPIC+ HF, EPIC II+ HF, PROMOTE (P030054/S104)ABBOTT MEDICAL2008-12-18
CONTACT RENEWAL (P010012/S195)Boston Scientific Corp2008-12-18
TELIGEN ICDS (P960040/S185)Boston Scientific2008-12-18
CONFIENT/TELIGEN/VITALITY (P960040/S184)Boston Scientific2008-12-18
COGNIS CRT-DS (P010012/S197)Boston Scientific Corp2008-12-18
RENEWAL 3/LIVIAN/COGNIS (P010012/S196)Boston Scientific Corp2008-12-18
PRIZM2/VITALITY (P960040/S183)Boston Scientific2008-12-18
CARPENTIER-EDWARDS BIOPROSTHESIS & BIOPROSTHETIC VALVED CONDUIT (P870056/S031)Edwards Lifesciences, LLC2008-12-17
ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S006)LeMaitre Vascular, Inc.2008-12-17
DUETT PRO SEALING DEVICE, MODEL 1010 (P990037/S028)Vascular Solutions, Inc.2008-12-17
MARQUIS/MAXIMO& MAXIMO II IPG/INTRINSIC/ENTRUST/VIRTUOSO II DR/VR/ONYX/VIRTUOSO FAMILY OF ICDS/SECURA ICD (P980016/S167)Medtronic Cardiac Rhythm Disease Management2008-12-17
KAPPA 600/700/650/800/900/ENPULSE/ENRHYTHM/SIGMA IPG/MEDTRONIC 350/ADAPTA/VERSA/SENSIA/RELIA/AT500 (P980035/S122)Medtronic, Inc.2008-12-17
INSYNC FAMILIES OF ICDS/CONCERTO CRT-D/MAXIMO II/CONSULTA/CONCERTO II CRT-D (P010031/S134)Medtronic Cardiac Rhythm Disease Management2008-12-17
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S030)Edwards Lifesciences, LLC2008-12-17
PRODIGY IPG (P890003/S158)Medtronic, Inc.2008-12-17
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S052)Edwards Lifesciences, LLC2008-12-17
KAPPA 400 DR/SR IPG (P970012/S047)Medtronic, Inc.2008-12-17
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S018)Edwards Lifesciences, LLC2008-12-17
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S019)Edwards Lifesciences, LLC2008-12-17
INSYNC III CRT-P & INSYNC CRT-P (P010015/S057)Medtronic, Inc.2008-12-17
CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S196)ABBOTT MEDICAL2008-12-16
WALLSTENT TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S026)Boston Scientific Corp2008-12-16
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P060008/S007)Boston Scientific Corp2008-12-16
TAXUS EXPRESS2 /TAXUS EXPRESS2 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P030025/S061)Boston Scientific Corp2008-12-16
WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S015)Boston Scientific Corporation2008-12-16
ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S025)Medtronic, Inc.2008-12-16
DRIVER CORONARY STENT SYSTEMS (P030009/S029)Medtronic, Ireland2008-12-15
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S008)Abbott Vascular, Inc.2008-12-15
MYNX VASCULAR CLOSURE DEVICE (P040044/S007)Cordis US Corporation2008-12-14
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S002)Abbott Vascular, Inc.2008-12-12
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S014)Edwards Lifesciences, LLC2008-12-12
JEWEL AND GEM FAMILIES OF ICDS (P900061/S079)Medtronic Cardiac Rhythm Disease Management2008-12-11
VARIOUS FAMILIES OF PACEMAKERS (P850051/S069)Medtronic, Inc.2008-12-11
VARIOUS FAMILIES OF PACEMAKERS (P820003/S087)Medtronic Cardiac Rhythm Disease Management2008-12-11
COGNIS CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR (P010012/S194)Boston Scientific Corp2008-12-11
VARIOUS FAMILIES OF CRT / ICDS (P010031/S130)Medtronic Cardiac Rhythm Disease Management2008-12-11
TELIGEN FAMILY (P960040/S182)Boston Scientific2008-12-11
LEGEND PLUS FAMILY OF PACEMAKERS (P930022/S008)Medtronic, Inc.2008-12-11
INSYNC PACEMAKER AND INSYNC III CRT-IPG (P010015/S055)Medtronic, Inc.2008-12-11
CARDIOMESSENGER II-S AND CARDIOMESSENGER II-S TLINE HOME MONITORING DEVICES (P050023/S016)Biotronik, Inc.2008-12-11
KAPPA, SIGMA, ENRHYTHM, ENPULSE, ADAPTA AND RELIA FAMILIES OF PACEMAKERS (P980035/S118)Medtronic, Inc.2008-12-11
VIATRON PACEMAKERS (P990001/S046)Medtronic, Inc.2008-12-11
GEM, ENTRUST, MARQUIS, MAXIMO, INTRINSIC AND VIRTUSO FAMILIES OF ICDS (P980016/S163)Medtronic Cardiac Rhythm Disease Management2008-12-11
VARIOUS FAMILIES OF PACEMAKERS, CARELINK PROGRAMMER MODEL 2090 (P890003/S151)Medtronic, Inc.2008-12-11
KAPPA/SIGMA/ENPULSE/ADAPTA/VERSA/SENSIA PACEMAKER FAMILIES (P980035/S120)Medtronic, Inc.2008-12-11
BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006)Boston Scientific Corp2008-12-11
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S022)Medtronic, Inc.2008-12-11
ANGIOPLASTY/LASER/CORONARY DEVICE (P910001/S028)Spectranetics Corp.2008-12-11
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