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Cardiovascular

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

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RecordFirmDate
MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW) (P910031/S022)Abbott Vascular Devices2006-02-16
NAVISTAR DS DIAGNOSTIC ABLATION DEFLECTABLE TIP CATHETER, (P010068/S008)Biosense Webster, Inc.2006-02-16
PHOTON MICRO & ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P910023/S097)ABBOTT MEDICAL2006-02-16
KAPPA 700, VITATRON, KAPPA 900, ENPULSE, SIGMA, MEDTRONIC 350 SERIES, ENRHYTHM (P980035/S049)Medtronic, Inc.2006-02-16
EASYTRAK 3 IS-1 AND LV-1 HEART FAILURE LEADS (P010012/S074)Boston Scientific Corp2006-02-16
NAVISTAR THERMOCOLD DIAGNOSTIC DEFLECTABLE TIP CATHETER, CEL (P030031/S003)Biosense Webster, Inc.2006-02-16
SCORPION/SCORPION M ABLATION CATHETER (P000020/S010)Boston Scientific Corp2006-02-16
QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD (P030054/S018)ABBOTT MEDICAL2006-02-15
MEDTRONIC PACEMAKER SYSTEMS (P890003/S096)Medtronic, Inc.2006-02-15
SETROX S STEROID-ELUTING ACTIVE-FIXATION ENDOCARDIAL PACING LEAD (MODELS SETROX S 45, SETROX S 53, AND SETROX S 60) (P950037/S042)Biotronik, Inc.2006-02-14
COOK ZENITH RENU AAA ANCILLARY GRAFT (P020018/S008)Cook, Inc.2006-02-09
PROGRAMMER TO SUPPORT VARIOUS PACEMAKERS & DEFIBRILLATORS (P830045/S092)St. Jude Medical, Inc.2006-02-08
POWERLINK SYSTEM (P040002/S002)Endologix, LLC2006-02-08
IDENTITY ADX FAMILY OF PACEMAKERS SYNCHRONCY DEVICE (P880086/S111)ABBOTT MEDICAL2006-02-08
TACHYCARDIA DEFIBRILLATOR DEVICES (P910023/S089)ABBOTT MEDICAL2006-02-08
TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC (P960013/S015)ABBOTT MEDICAL2006-02-07
CAPSUREFIX MODELS 4568, 4067, 5068, 5067, 5568; SUREFIX MODEL 5072; SPRINT MODELS 6945, 6943; SPRINT QUATTRO MODEL 6947 (P920015/S031)Medtronic, Inc.2006-02-07
CAPSUREFIX MODELS 4568, 4067, 5068, 5067, 5568; SUREFIX MODEL 5072; SPRINT MODELS 6945, 6943; SPRINT QUATTRO MODEL 6947 (P930039/S020)Medtronic, Inc.2006-02-07
AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM (P020024/S006)ABBOTT MEDICAL2006-02-06
AMPLATZER DUCT OCCLUDER AND AMPLATZER 180 DEGREE DELIVERY AND EXCHANGE SYSTEM (P020024/S008)ABBOTT MEDICAL2006-02-06
BIRD'S NEST VENA CAVA FILTER (P850049/S009)Cook, Inc.2006-02-03
S660 OVER THE WIRE CORONARY STENT SYSTEM, S660 ZIPPER MX CORONARY STENT SYSTEM (P970035/S046)Medtronic, Ireland2006-02-01
MAXIMO DR/ VR MODEL 7278 AND 7232 ICD SYSTEMS (P980016/S060)Medtronic Cardiac Rhythm Disease Management2006-02-01
POWERLINK SYSTEM (P040002/S003)Endologix, LLC2006-02-01
CARBOMEDICS PROSTHETIC HEART VALVE (P900060/S036)Corcym S.r.l.2006-02-01
IDENTITY/IDENTITY ADX, INTEGRITY, AFFINITY, AND ENTITY PULSE GENERATOR MODELS (P880086/S110)ABBOTT MEDICAL2006-01-31
LINOX SD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS (P980023/S020)Biotronik, Inc.2006-01-27
MOSAIC BIOPROSTHESIS MODELS 305 AND 310 (P990064/S013)Medtronic, Inc.2006-01-27
HANCOCK II BIOPROSTHESIS, MODELS T505 AND T510 (P980043/S008)Medtronic, Inc.2006-01-27
NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER (P990025/S009)Biosense Webster, Inc.2006-01-26
CARELINK MONITORS, MODELS 2490G AND 2490J (P890003/S084)Medtronic, Inc.2006-01-24
CARELINK MONITORS, MODELS 2490G AND 2490J (P980016/S050)Medtronic Cardiac Rhythm Disease Management2006-01-24
CARELINK MONITORS, MODELS 2490G AND 2490J (P010031/S022)Medtronic Cardiac Rhythm Disease Management2006-01-24
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S008)W. L. Gore & Associates, Inc.2006-01-20
CONTAK RENEWAL 3 (P010012/S090)Boston Scientific Corp2006-01-20
CONTAK RENEWAL 3 (P010012/S095)Boston Scientific Corp2006-01-20
CONTAK RENEWAL 3 (P010012/S088)Boston Scientific Corp2006-01-20
CONTAK RENEWAL TR (P030005/S028)Guidant Corp.2006-01-20
RENEWAL (P010012/S094)Boston Scientific Corp2006-01-20
PHOTON, EPIC AND ATLAS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P910023/S090)ABBOTT MEDICAL2006-01-20
VITALITY, PRIZM (P960040/S105)Boston Scientific2006-01-20
VITALITY, PRIZM (P960040/S103)Boston Scientific2006-01-20
IBI CARDIAC ABLATION SYSTEM (P040014/S001)Irvine Biomedical, Inc.2006-01-20
PRIZM/VITALITY (P960040/S098)Boston Scientific2006-01-20
BIOGLUE SURGICAL ADHESIVE (P010003/S005)Cryolife, Inc.2006-01-20
VITALITY, PRIZM (P960040/S097)Boston Scientific2006-01-20
VITALITY (P960040/S102)Boston Scientific2006-01-20
DISCOVERY, MERIDIAN (P940031/S049)Boston Scientific2006-01-20
CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL 3 RF (P010012/S096)Boston Scientific Corp2006-01-20
CONTAK RENEWAL (P010012/S089)Boston Scientific Corp2006-01-20
VITALITY (P960040/S099)Boston Scientific2006-01-20
CONTAK RENEWAL, CONTAK RENEWAL 3 (P010012/S097)Boston Scientific Corp2006-01-20
FINELINE II / THINLINE II FAMILY OF LEADS (P960004/S032)Boston Scientific2006-01-19
CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE (P010012/S101)Boston Scientific Corp2006-01-19
CONTAK RENEWAL 3 RF (P010012/S092)Boston Scientific Corp2006-01-19
THINLINE II/ FINELINE II (P960004/S030)Boston Scientific2006-01-19
THINLINE 2 FINELINE 2 (P960004/S029)Boston Scientific2006-01-19
VITALITY, PRIZM (P960040/S107)Boston Scientific2006-01-19
VITALITY (P960040/S096)Boston Scientific2006-01-17
ATS MEDIAL HEART VALVE (P990046/S014)Medtronic Ats Medical, Inc.2006-01-17
FINELINE MODEL 6066 (P960004/S031)Boston Scientific2006-01-17
EASYTRAK LEADS (P010012/S091)Boston Scientific Corp2006-01-17
CONTAK RENEWAL 3 (P010012/S087)Boston Scientific Corp2006-01-17
CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC/ VALSALVA ASCENDING AORTIC PROSTHESIS (P900060/S035)Corcym S.r.l.2006-01-13
VENTAK FAMILY OF IMPLANTABLE CARIOVERTER DEFIBRILLATOR (P960040/S094)Boston Scientific2006-01-13
CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S016)Cordis Corp.2006-01-12
GUIDANT EASY-TRACK 2 LEADS (P010012/S100)Boston Scientific Corp2006-01-11
MAVERICK FAMILY PTCA BALLOON CATHETERS, MAVERICK OTW, MAVERICK2 MONORAIL (MR), QUANTUM MAVERICK OTW AND QUANTUM MAVERICK (P860019/S206)Scimed Life Systems, Inc.2006-01-10
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (P910023/S091)ABBOTT MEDICAL2006-01-10
ON-X PROSTHETIC HEART VALVE (P000037/S010)On-X Life Technologies, Inc.2006-01-10
TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S024)Boston Scientific Corp2006-01-06
ON-X PROSTHETIC HEART VALVE (P000037/S009)On-X Life Technologies, Inc.2006-01-06
MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S022)Medtronic Vascular2006-01-04
ENDOTAK RELIANCE G/SG LEADS (P910073/S061)Boston Scientific2005-12-30
STELIX II ENDOCARDIAL PACING LEADS (P020030/S002)MicroPort CRM USA, Inc.2005-12-29
EPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM (P020025/S014)Boston Scientific2005-12-23
EPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM (P920047/S030)Boston Scientific Corp2005-12-23
DRIVER CORONARY STENT SYSTEM FAMILY OF PRODUCTS (P030009/S004)Medtronic, Ireland2005-12-22
VARIOUS MODELS OF PACEMAKERS (P820003/S075)Medtronic Cardiac Rhythm Disease Management2005-12-22
VARIOUS FAMILIES OF ICDS (P980016/S063)Medtronic Cardiac Rhythm Disease Management2005-12-22
KAPPA 400 FAMILY & PACEMAKERS (P970012/S019)Medtronic, Inc.2005-12-22
VARIOUS FAMILIES OF PACEMAKERS (P850051/S060)Medtronic, Inc.2005-12-22
INSYNC FAMILIES OF CRT-ICDS (P010031/S032)Medtronic Cardiac Rhythm Disease Management2005-12-22
VARIOUS FAMILIES OF PACEMAKERS (P980035/S051)Medtronic, Inc.2005-12-22
VARIOUS FAMILIES OF PACEMAKERS (P990001/S022)Medtronic, Inc.2005-12-22
VARIOUS FAMILIES OF ICD (P900061/S059)Medtronic Cardiac Rhythm Disease Management2005-12-22
INSYNC/INSYNC III CRT-IPGS (P010015/S018)Medtronic, Inc.2005-12-22
MEDTRONIC VASCULAR DRIVER RAPID EXCHANGE CORONARY STENT SYSTEM (P030009/S003)Medtronic, Ireland2005-12-22
JEWEL AF,GEM III AT FAMILY OF ICDS (P980050/S019)Medtronic, Inc.2005-12-22
LEGEND PLUS FAMILY OF PACEMAKERS (P930022/S002)Medtronic, Inc.2005-12-22
MEDTRONIC PACEMAKER SYSTEMS (P890003/S093)Medtronic, Inc.2005-12-22
DISCOVERY, MERIDIAN (P940031/S045)Boston Scientific2005-12-21
STARCLOSE VASCULAR CLOSURE SYSTEM (P050007)Abbott Vascular Devices2005-12-21
CONTAK RENEWAL 3 (P010012/S077)Boston Scientific Corp2005-12-21
CONTAK RENEWAL TR (P030005/S021)Guidant Corp.2005-12-21
CYLOS FAMILY OF PULSE GENERATORS (P950037/S041)Biotronik, Inc.2005-12-21
LIBERTE CORONARY STENT SYSTEM (P040016/S007)Boston Scientific Scimed, Inc.2005-12-21
VITALITY HE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S087)Boston Scientific2005-12-21
IBI THERAPY DUAL 8 ABLATION CATHETERS (P040042/S001)Irvine Biomedical,Inc.(Ibi)2005-12-21
GUIDANT ZOOM PROGRAMMER (P910077/S055)Boston Scientific2005-12-20
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