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Cardiovascular

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

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RecordFirmDate
WALLSTENT IIIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S025)Boston Scientific Scimed, Inc.2011-08-17
AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S207)ABBOTT MEDICAL2011-08-17
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S072)St. Jude Medical, Inc.2011-08-17
ATTAIN STARFIX LEAD (P060039/S030)Medtronic, Inc.2011-08-15
VITATRON DA+C & VITATRON DA+T SERIES IPGS (P990001/S094)Medtronic, Inc.2011-08-15
REVO MRI (P090013/S033)Medtronic, Inc.2011-08-15
TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH) (P980050/S066)Medtronic, Inc.2011-08-15
CAPSURE, CAPSURE Z NOVUS, VARIOUS MODELS OF VITATRON (P850089/S083)Medtronic Cardiac Rhythm Disease Management2011-08-15
MODEL 4296 ATTAIN ABILITY PLUS LV LEAD AND MODEL 4396 ATTAIN ABILITY STRAIGHT LV LEAD (P080006/S034)Medtronic, Inc.2011-08-15
ADVISA, AT500, ENRHYTHM (P980035/S237)Medtronic, Inc.2011-08-15
CONCERTO/CONCERTO II, CONSULTA, VARIOUS INSYNC MODELS, MAXIMO II, PROTECTA/PROTECTA XT (P010031/S270)Medtronic Cardiac Rhythm Disease Management2011-08-15
CAPSURE, VITATRON CRYSTALLINE ACTFIX (P930039/S061)Medtronic, Inc.2011-08-15
Y ADAPTOR/EXTENDER KIT/DF-1 PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/TOOL/LEAD ADAPTOR/SPRINT QUATTRO/SUBCUTANEOUS (P920015/S082)Medtronic, Inc.2011-08-15
350 SERIES, ADAPTA, ADVISA, ENRHYTHM, RELIA, SENSIA, SIGMA, VERSA (P980035/S238)Medtronic, Inc.2011-08-15
ENTRUST, INSTRINSIC, MARQUIS, SECURA, VARIOUS MODELS OF MAXIMO, PROTECTA, & VIRTUOSO (P980016/S315)Medtronic Cardiac Rhythm Disease Management2011-08-15
RF CONDUCTR MC/RF CONTACTR/RF ENHANCR II/RF MARINR MC 7F/SC 5F/RF MARNIR UNIPOLAR/RF CONDUCTR MC ABLATION CATHETERS (P930029/S033)Medtronic, Inc.2011-08-15
SYNCRA CRT-P, CONSULTA CRT-P, INSYNC CRT-P, INSYNC III CRT-P (P010015/S135)Medtronic, Inc.2011-08-15
SELECTSECURE LEAD/SLEEVE KIT (P030036/S036)Medtronic Cardiac Rhythm Disease Management2011-08-15
CAPSURE EPICARDIAL PACING LEAD (P950024/S035)Medtronic, Inc.2011-08-15
CONCERTO/CONCERTOI II. CONSULTA, VARIOUS INSYNC MODELS, MAXIMO II, PROTECTA/PROTECTS XT (P010031/S269)Medtronic Cardiac Rhythm Disease Management2011-08-15
EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S195)ABBOTT MEDICAL2011-08-15
CAPSURE, VITATRON CRYSTALINE, & VITATRON EXCELLENCE +/PS+ (P830061/S071)Medtronic Cardiac Rhythm Disease Management2011-08-15
REVO MRI, CAPSURE FIX LEAD (P090013/S034)Medtronic, Inc.2011-08-15
DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1 (P900061/S108)Medtronic Cardiac Rhythm Disease Management2011-08-15
CAPSURE LEAD, CAPSURE MODEL LEAD, PRODIGY IPG (P890003/S234)Medtronic, Inc.2011-08-15
CADENCE FAMILY OF ICDS (P910023/S269)ABBOTT MEDICAL2011-08-15
SYNCRA CRT-P, CONSULTA CRT-P, INSYNC III, ATTAIN (P010015/S136)Medtronic, Inc.2011-08-15
DISPOABLE COVER & EPG SAFETY CABLE (P820003/S110)Medtronic Cardiac Rhythm Disease Management2011-08-15
CAPSURE; ENTRUST; INTRINSIC; MARQUIS; VARIOUS MODELS OF MAXIMO, VIRTUOSO, & PROTECTA; SECURA (P980016/S316)Medtronic Cardiac Rhythm Disease Management2011-08-15
BLAZER PRIME XP CARDIAC ABLATION CATHETER (P020025/S026)Boston Scientific2011-08-12
EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S194)ABBOTT MEDICAL2011-08-12
MAXIMO II/SECURA/VIRTUOSO II (P980016/S313)Medtronic Cardiac Rhythm Disease Management2011-08-12
CONCERTO II/CONSULTA/MAXIMO II (P010031/S267)Medtronic Cardiac Rhythm Disease Management2011-08-12
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S067)Boston Scientific Corp2011-08-12
BLAZER PRIME HTD CARDIAC ABLATION CATHETER (P920047/S045)Boston Scientific Corp2011-08-12
CADENCE FAMILY OF ICDS (P910023/S268)ABBOTT MEDICAL2011-08-12
CONCERTO II/CONSULTA/MAXIMO II (P010031/S266)Medtronic Cardiac Rhythm Disease Management2011-08-11
ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S076)ABBOTT MEDICAL2011-08-11
ACCENT FAMILY OF PACEMAKERS (P880086/S206)ABBOTT MEDICAL2011-08-11
MAXIMO II/SECURA/VIRTUOSO II (P980016/S312)Medtronic Cardiac Rhythm Disease Management2011-08-11
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S014)Boston Scientific Corp2011-08-11
SUTURE MEDICATED CLOSURE SYSTEMS, PERCUTANEOUS VASCULAR SURGICAL SYSTEMS AND ASSOCIATED ACCESORIES (P960043/S074)Abbott Vascular, Inc.2011-08-10
VISION AND MINVISION CORONARY STENT SYSTEMS (P020047/S037)Abbott Vascular2011-08-10
XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S076)Abbott Vascular, Inc.2011-08-10
MULTILINK ZETA CORONARY STENT SYSTEMS (P970020/S066)Abbott Vascular, Inc.2011-08-10
ENDURANT STENT GRAFT SYSTEM (P100021/S009)Medtronic Vascular2011-08-10
VASCULAR CLOSURE SYSTEMS (P050007/S029)Abbott Vascular Devices2011-08-10
ACUITY SPIRAL LEAD FAMILY (P010012/S260)Boston Scientific Corp2011-08-05
CONNECTOR SLEEVE ACCESSORY KIT (P950022/S077)ABBOTT MEDICAL2011-08-05
EASYTRAK 2 IS-1 LEAD (P010012/S268)Boston Scientific Corp2011-08-05
CONNECTOR SLEEVE ACCESSORY KIT (P030054/S192)ABBOTT MEDICAL2011-08-05
RF CONDUCTR MC/RF CONTACTR/RF ENHANCR II/RF MARINR MC 7F/SC 5F/RF MARNIR UNIPOLAR/RF CONDUCTR MC ABLATION CATHETERS (P930029/S032)Medtronic, Inc.2011-08-04
VITATRON LEGACY (P850051/S077)Medtronic, Inc.2011-08-04
MAXIMO II/SECURA/VIRTUOSO II (P980016/S311)Medtronic Cardiac Rhythm Disease Management2011-08-04
CONCERTO II/CONSULTA/MAXIMO II (P010031/S265)Medtronic Cardiac Rhythm Disease Management2011-08-04
DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1 (P900061/S106)Medtronic Cardiac Rhythm Disease Management2011-08-04
SELECTSECURE LEAD/SLEEVE KIT (P030036/S035)Medtronic Cardiac Rhythm Disease Management2011-08-04
VITATRON DA+C & VITATRON DA+T SERIES IPGS (P990001/S092)Medtronic, Inc.2011-08-04
CONCERTO II/CONSULTA/MAXIMO II (P010031/S264)Medtronic Cardiac Rhythm Disease Management2011-08-04
MAXIMO II/SECURA/VIRTUOSO II (P980016/S310)Medtronic Cardiac Rhythm Disease Management2011-08-04
ATTAIN STARFIX LEAD (P060039/S029)Medtronic, Inc.2011-08-04
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S009)Boston Scientific Corp2011-08-04
WALLSTENT (TIPS) ENDOPROSTHESIS (P930031/S030)Boston Scientific Corp2011-08-04
CAPSURE, VITATRON CRYSTALINE AND VITATRON EXCELLENCE PS (P830061/S070)Medtronic Cardiac Rhythm Disease Management2011-08-04
DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1 (P900061/S107)Medtronic Cardiac Rhythm Disease Management2011-08-04
VITATRON DA+C & VITATRON DA+T SERIES IPGS (P990001/S093)Medtronic, Inc.2011-08-04
CAPSURE, VITATRON CRYSTALLINE ACTFIX (P930039/S060)Medtronic, Inc.2011-08-04
LIBERTE CORONARY STENT SYSTEM (P040016/S075)Boston Scientific Scimed, Inc.2011-08-04
ION PACLIYAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S012)Boston Scientific Corp2011-08-04
CAPSURE FIX LEAD & REVO MRI IPG (P090013/S031)Medtronic, Inc.2011-08-04
MODEL 4296 ATTAIN ABILITY PLUS LV LEAD AND MODEL 4396 ATTAIN ABILITY STRAIGHT LV LEAD (P080006/S033)Medtronic, Inc.2011-08-04
DISPOABLE COVER & EPG SAFETY CABLE (P820003/S109)Medtronic Cardiac Rhythm Disease Management2011-08-04
ADAPTA, RELIA, SENSIA, & VERSA (P980035/S235)Medtronic, Inc.2011-08-04
ATTAIN LEAD/CONSULTA CRT-P/INSYNC III/SYNCRA CRT-PS (P010015/S132)Medtronic, Inc.2011-08-04
Y ADAPTOR/EXTENDER KIT/DF-1 PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/TOOL/LEAD ADAPTOR/SPRINT QUATTRO/SUBCUTANEOUS (P920015/S081)Medtronic, Inc.2011-08-04
CUTTING BALLOON ULTRA 2 MONORAIL AND FLEXTOME CUTTING BALLOON MONORAIL (P950020/S046)Boston Scientific Corp2011-08-04
CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT (P890003/S232)Medtronic, Inc.2011-08-04
WALLSTENT (VENOUS) ENDOPROSTHESIS (P980033/S019)Boston Scientific Corporation2011-08-04
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM MONORAIL (P100023/S011)Boston Scientific Corp2011-08-04
LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S037)St Jude Medical2011-08-04
WALLSTENT (IIIAC) ENDOPROSTHESIS (P940019/S026)Boston Scientific Scimed, Inc.2011-08-04
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S074)Boston Scientific Corp2011-08-04
SYNCRA CRT-P, CONSULTA CRT-P, INSYNC CRT-P, INSYNC III CRT-P (P010015/S134)Medtronic, Inc.2011-08-04
TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH) (P980050/S065)Medtronic, Inc.2011-08-04
CAPSURE EPICARDIAL PACING LEAD (P950024/S034)Medtronic, Inc.2011-08-04
KAPPA 400 IPG (P970012/S088)Medtronic, Inc.2011-08-04
CAPSURE FIX LEAD & REVO MRI IPG (P090013/S032)Medtronic, Inc.2011-08-04
CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT (P890003/S233)Medtronic, Inc.2011-08-04
ADAPTA, RELIA, SENSIA, & VERSA (P980035/S236)Medtronic, Inc.2011-08-04
POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) (P850089/S082)Medtronic Cardiac Rhythm Disease Management2011-08-04
CADENCE FAMILY OF ICDS (P910023/S264)ABBOTT MEDICAL2011-08-03
MICRONY FAMILY OF PACEMAKERS (P970013/S040)ABBOTT MEDICAL2011-08-03
FRONTIER/FRONTIERII/ANTHEM FAMILY OF CRT-PS (P030035/S083)ABBOTT MEDICAL2011-08-03
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S071)St. Jude Medical, Inc.2011-08-03
LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S029)Zoll Manufacturing Corporation2011-08-03
AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S203)ABBOTT MEDICAL2011-08-03
EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S189)ABBOTT MEDICAL2011-08-03
FRONTIER/FRONTIER II/ANTHEM FAMILIES OF CRT-PS (P030035/S078)ABBOTT MEDICAL2011-08-02
AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILIES OF PACEMAKERS (P880086/S198)ABBOTT MEDICAL2011-08-02
EPIC HF/ATLAS+HF/PROMOTE/UNIFY FAMILIES OF CRT-DS (P030054/S180)ABBOTT MEDICAL2011-08-02
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Every clearance here is in the API, with alerts when new ones post.