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Cardiovascular

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

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RecordFirmDate
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S005)Boston Scientific Corp2012-04-05
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S030)Boston Scientific Corp2012-04-05
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (ALSO DISTRIBUTED AS PROMUS EECSS) (P070015/S086)Abbott Vascular, Inc.2012-04-05
MYNXGRIP VASCULAR CLOSURE DEVICE (P040044/S043)Cordis US Corporation2012-04-05
CARPENTIER-EDWARDS VALVED CONDUIT, MODEL 4300 (P870056/S047)Edwards Lifesciences, LLC2012-04-04
MAXIMO VR ICD (P980016/S345)Medtronic Cardiac Rhythm Disease Management2012-04-04
ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (P020018/S040)Cook, Inc.2012-04-04
CAPSUREFIX MRI LEAD (P090013/S058)Medtronic, Inc.2012-04-04
SELECTSECURE LEAD (P030036/S042)Medtronic Cardiac Rhythm Disease Management2012-04-04
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S046)W. L. Gore & Associates, Inc.2012-04-04
AORTIC FRONT CARDIAC CRYOABLATION CATHETERS (P100010/S016)Medtronic Cryocath, LP2012-04-04
CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT (P010031/S232)Medtronic Cardiac Rhythm Disease Management2012-04-04
ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA VERSA IPG (P980035/S266)Medtronic, Inc.2012-04-04
CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD & VITATRON CRYSTALLINE LEADS (P930039/S067)Medtronic, Inc.2012-04-04
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P110010/S008)Boston Scientific Corp2012-04-03
MULTI-LINK 8 CORONARY STENT SYSTEM (P020047/S042)Abbott Vascular2012-04-03
OPEN PIVOT AORTIC VALVED GRAFT (P990046/S027)Medtronic Ats Medical, Inc.2012-04-03
INSYNC ICD MODEL 7272 (P010031/S297)Medtronic Cardiac Rhythm Disease Management2012-04-02
KAPPA 700 (P980035/S265)Medtronic, Inc.2012-04-02
INSYNC ICD MODEL 7272 (P010031/S295)Medtronic Cardiac Rhythm Disease Management2012-04-02
REVO MRI (P090013/S056)Medtronic, Inc.2012-04-02
TRANSVENE LEADS (P920015/S089)Medtronic, Inc.2012-04-02
ACTIVITRAX (P890003/S248)Medtronic, Inc.2012-04-02
INSYNC MODEL 8040 PULSE GENERATOR (P010015/S158)Medtronic, Inc.2012-04-02
KAPPA 400 (P980035/S263)Medtronic, Inc.2012-04-02
VITATRON (P990001/S102)Medtronic, Inc.2012-04-02
VITATRON (P990001/S103)Medtronic, Inc.2012-04-02
INSYNC MODEL 8040 PULSE GENERATOR (P010015/S156)Medtronic, Inc.2012-04-02
GEM DR (P980016/S342)Medtronic Cardiac Rhythm Disease Management2012-04-02
REVO MRI (P090013/S057)Medtronic, Inc.2012-04-02
GEM DR (P980016/S344)Medtronic Cardiac Rhythm Disease Management2012-04-02
EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELECTROPHYSIOLOGY CATHETER (P040036/S029)Biosense Webster, Inc.2012-03-30
EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELECTROPHYSIOLOGY CATHETER & THERMOCOOL SF NAV CATHETER (P030031/S040)Biosense Webster, Inc.2012-03-30
CORONARY FLEXTOME CUTTING BALLOON (P950020/S049)Boston Scientific Corp2012-03-30
EZ STEER NAV ELECTROPHYSIOLOGY CATHETER (P990025/S030)Biosense Webster, Inc.2012-03-30
INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S253)Boston Scientific2012-03-30
INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S283)Boston Scientific Corp2012-03-30
NAVISTAR DS ELECTROPHYSIOLOGY CATHETER (P010068/S026)Biosense Webster, Inc.2012-03-30
CARDIO MESSENGER II & CARDIO MESSENGER II-S FAMILIES (P950037/S102)Biotronik, Inc.2012-03-29
CARDIO MESSENGER & CARDIO MESSENGER II-S FAMILIES (P050023/S049)Biotronik, Inc.2012-03-29
HEARTMATE II LVAS (P060040/S016)ABBOTT MEDICAL2012-03-29
LUMAX ICDS AND CRT-DS (P050023/S050)Biotronik, Inc.2012-03-29
RX ACCULINK CAROTID STENT SYSTEM (P040012/S042)Abbott Vascular2012-03-29
TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S254)Boston Scientific2012-03-28
COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S284)Boston Scientific Corp2012-03-28
SPRINT QUATTRO SECURE LEAD (DF4) (P920015/S087)Medtronic, Inc.2012-03-26
EVIA / ENTOVIS FAMILY PULSE GENERATORS (P950037/S101)Biotronik, Inc.2012-03-23
TAXUS LIBERTE MR CORONARY STENT SYSTEM & TAXUS LIBERTE OTW CORONARY STENT SYSTEM (P060008/S072)Boston Scientific Corp2012-03-23
JEWEL AF MODEL 7250 (P980050/S071)Medtronic, Inc.2012-03-23
INSYNC MODEL 8040 PULSE GENERATOR (P010015/S155)Medtronic, Inc.2012-03-23
7261A PCD (P900061/S112)Medtronic Cardiac Rhythm Disease Management2012-03-23
MECHANICAL HEART VALVE (P810002/S081)ABBOTT MEDICAL2012-03-23
4965 EPICARDIAL LEAD (P950024/S041)Medtronic, Inc.2012-03-23
BLAZER II, BLAZER II HTD CARDIAC ABLATION CATHETERS & BLAZER PRIME HTD CARDIAC ABLATION CATHETER & STERILE CABLES (P920047/S048)Boston Scientific Corp2012-03-23
SELECTSECURE (P030036/S041)Medtronic Cardiac Rhythm Disease Management2012-03-23
4003/4503 CAPSURE (P830061/S075)Medtronic Cardiac Rhythm Disease Management2012-03-23
4068 CAPSUREFIX (P930039/S066)Medtronic, Inc.2012-03-23
4195 ATTAIN STARFIX (P060039/S034)Medtronic, Inc.2012-03-23
VERIFLEX MR CORONARY STENT SYSTEM & VERIFLEX OTW CORONARY STENT SYSTEM (P040016/S073)Boston Scientific Scimed, Inc.2012-03-23
INSYNC ICD MODEL 7272 (P850089/S087)Medtronic Cardiac Rhythm Disease Management2012-03-23
ACTIVITRAX (P890003/S246)Medtronic, Inc.2012-03-23
ATAKR RFCA SYSTEM (P930029/S036)Medtronic, Inc.2012-03-23
4196 ATTAIN ABILITY LEAD (P080006/S040)Medtronic, Inc.2012-03-23
BLAZER II XP, BLAZER PRIME XP & BLAZER XP RPM CARDIAC ABLATION CATHETERS & STERILE CABLES (P020025/S029)Boston Scientific2012-03-23
ION PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S005)Boston Scientific Corp2012-03-23
MULTI-LINK OTW ULTRA & MULTI-LINK RX ULTRA CORONARY STENT SYSTEM (P970020/S073)Abbott Vascular, Inc.2012-03-23
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S107)Boston Scientific Corp2012-03-23
INSYNC ICD MODEL 7272 (P010031/S294)Medtronic Cardiac Rhythm Disease Management2012-03-23
TRANSVENE LEADS (P920015/S088)Medtronic, Inc.2012-03-23
MULTI-LINK 8 CORONARY STENT SYSTEM (P020047/S047)Abbott Vascular2012-03-23
EXPRESS SD RENAL MR PREMOUNTED STENT SYSTEM (P060006/S021)Boston Scientific Corp2012-03-23
KAPPA 700 (P820003/S115)Medtronic Cardiac Rhythm Disease Management2012-03-23
VITATRON (P990001/S101)Medtronic, Inc.2012-03-23
KAPPA 400 (P980035/S262)Medtronic, Inc.2012-03-23
CHILLI II COOLED ABLATION SYSTEM & STERILE CABLES (P980003/S030)Boston Scientific Corp2012-03-23
THERMACOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL CATHETERS (P030031/S038)Biosense Webster, Inc.2012-03-23
REVO MRI (P090013/S055)Medtronic, Inc.2012-03-23
4195 ATTAIN STARFIX (P980016/S341)Medtronic Cardiac Rhythm Disease Management2012-03-23
EXPRESS 2 MR CORONARY STENT SYSTEM & EXPRESS 2 OTW CORONARY STENT SYSTEM (P020009/S075)Boston Scientific Scimed, Inc.2012-03-23
PRECISE, PRECISE RX, AND PRECISE PRO RXNITINOL STENT SYSTEMS (P030047/S024)Cordis US Corporation2012-03-22
NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM (P020036/S023)Cordis US Corporation2012-03-22
CONCERTO / PROTECTA (P010031/S293)Medtronic Cardiac Rhythm Disease Management2012-03-22
CARPENTIER-EDWARDS BIOPROSTHESIS MODEL 2625 AND 6625 (P870056/S046)Edwards Lifesciences, LLC2012-03-22
XIENCE V, XIENCE NANO, PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S091)Abbott Vascular, Inc.2012-03-22
CARELINK HOME MONITOR MODEL 2491 (P890003/S245)Medtronic, Inc.2012-03-22
XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S015)Abbott Vascular2012-03-22
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S086)Edwards Lifesciences, LLC2012-03-22
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS MODEL# 6625LP AND 6625-ESR-LP (P870077/S042)Edwards Lifesciences, LLC2012-03-22
REVO MRI (P090013/S054)Medtronic, Inc.2012-03-22
ENTRUST / VIRTUOSO / PROTECTA (P980016/S340)Medtronic Cardiac Rhythm Disease Management2012-03-22
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S029)Edwards Lifesciences, LLC2012-03-22
EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX (P100041/S007)Edwards Lifesciences, LLC2012-03-22
CARPENTIER-EDWARDS SUPRAANULAR BIOPROSTHESIS MODEL 2650 (P010041/S031)Edwards Lifesciences, LLC2012-03-22
ENRHYTHM / ENRHYTHM MRI (P980035/S261)Medtronic, Inc.2012-03-22
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S078)St. Jude Medical, Inc.2012-03-21
MICRONY FAMILY OF PACEMAKERS (P970013/S047)ABBOTT MEDICAL2012-03-21
AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S217)ABBOTT MEDICAL2012-03-21
CADENCE/CURRENT FAMILY OF ICDS (P910023/S293)ABBOTT MEDICAL2012-03-21
FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S095)ABBOTT MEDICAL2012-03-21
MEDTRONIC SPRINT QUATTRO SECURE DF4 LEAD MODEL 6947M (P920015/S086)Medtronic, Inc.2012-03-21
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