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Cardiovascular

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

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RecordFirmDate
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S060)Boston Scientific Corp2011-03-31
BLAZER II XP CARDIAC ABLATION CATHETER/CABLE/BLAZER II HIGH TORQUE DISTAL (HTD) ABLATION CATHETER/CABLE/BLAZER PRIME (P920047/S044)Boston Scientific Corp2011-03-31
APEX MONORAIL & APEX OTW PTCA DILATATION CATHETER/MAVERICK2 MONORAIL PTCA CATHETER/MAVERICK OTW PTCA CATHETER/MAVERICK (P860019/S264)Scimed Life Systems, Inc.2011-03-31
CONCERTO II/CONSULTA/MAXIMO II CRT-DS (P010031/S239)Medtronic Cardiac Rhythm Disease Management2011-03-31
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S091)Boston Scientific Corp2011-03-31
BLAZER II XP CARDIAC ABLATION CATHETER & CABLE/BLAZER PRIME XP CARDIAC ABLATION CATHETER (P020025/S025)Boston Scientific2011-03-31
MEDTRONIC REVO MRI SURESCAN PACING SYSTEM (P090013/S007)Medtronic, Inc.2011-03-31
EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S017)Boston Scientific Corp2011-03-31
VITATRON DA+C & VITATRON DA+T SERIES IPGS (P990001/S085)Medtronic, Inc.2011-03-31
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE WITH WIRECLIP TORQUER (P900056/S103)Boston Scientific Corp2011-03-31
OVATIO CARDIAC RESYNCHRONIZATION THERAPY (CRT) AND SITUS OVER THE WIRE (OTW) LEFT VENTRICULAR (LV) LEAD (P060027/S030)MicroPort CRM USA, Inc.2011-03-31
STELID II BFT/BJF/STELIX BR/STELIX II BRF (P020030/S008)MicroPort CRM USA, Inc.2011-03-31
MAXIMO II/SECURA/VIRTUOSO II ICDS (P980016/S285)Medtronic Cardiac Rhythm Disease Management2011-03-31
ISOLINE 2CT & 2 CR (P980049/S063)MicroPort CRM USA, Inc.2011-03-31
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S063)Boston Scientific Scimed, Inc.2011-03-31
MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD (P080006/S004)Medtronic, Inc.2011-03-31
REVO MRI IPG (P090013/S008)Medtronic, Inc.2011-03-31
CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX & PIROUET S+ (P930039/S048)Medtronic, Inc.2011-03-30
ACCULINK CAROTID STENT SYSTEM (P040012/S037)Abbott Vascular2011-03-30
ACCULINK CAROTID STENT SYSTEM (P040012/S038)Abbott Vascular2011-03-30
CAPSURE FIX (P090013/S004)Medtronic, Inc.2011-03-30
CAPSURE EPICARDIAL PACING (P950024/S028)Medtronic, Inc.2011-03-30
ACCESSORY-UPSIZING SLEEVE/LEAD END PIN CAP (P900061/S099)Medtronic Cardiac Rhythm Disease Management2011-03-30
CAPSURE/CAPSURE MODEL/SERVICE KIT (P890003/S216)Medtronic, Inc.2011-03-30
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S012)Spectranetics Corp.2011-03-30
MEDTRONIC SELECTSECURE LEAD MODEL 3830 (P030036/S004)Medtronic Cardiac Rhythm Disease Management2011-03-30
CAPSURE/Z NOVUS/VITATRON EXCELLENCE SS+/IMPULSE II (P850089/S073)Medtronic Cardiac Rhythm Disease Management2011-03-30
SPRINT QUATTRO/SUBCUTANEOUS LEAD/TRANSVENE SVC LEAD (P920015/S073)Medtronic, Inc.2011-03-30
SELECTSECURE (P030036/S026)Medtronic Cardiac Rhythm Disease Management2011-03-30
TRANSVENE CS/SVC (P980050/S058)Medtronic, Inc.2011-03-30
CAPSURE/VITATRON CRYSTALINE & EXCELLENCE PS+ (P830061/S060)Medtronic Cardiac Rhythm Disease Management2011-03-30
MICRONY FAMILY OF PACEMAKERS (P970013/S039)ABBOTT MEDICAL2011-03-30
XACT CAROTID STENT SYSTEM (P040038/S021)Abbott Vascular, Inc.2011-03-30
ATTAIN STARFIX (P060039/S022)Medtronic, Inc.2011-03-30
ATTAIN (P010015/S109)Medtronic, Inc.2011-03-30
ATTAIN ABILITY (P080006/S020)Medtronic, Inc.2011-03-30
MEDTRONIC REVO MRI SURESCAN PACING SYSTEM (P090013/S005)Medtronic, Inc.2011-03-28
LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S026)Zoll Manufacturing Corporation2011-03-28
EVIA / ENTOVIS FAMILY OF PULSE GENERATORS (P950037/S091)Biotronik, Inc.2011-03-25
MEDTRONIC REVO MRI SURESCAN PACING SYSTEM (P090013/S003)Medtronic, Inc.2011-03-25
MEDTRONIC CARELINK MONITOR MODEL 2490C, CARDIOSIGHT READER (P890003/S177)Medtronic, Inc.2011-03-25
PROTECTA XT CRT-D AND PROTECTA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION; MODEL SW009 (P010031/S171)Medtronic Cardiac Rhythm Disease Management2011-03-25
MEDTRONIC PROTECTA XT DR D314DRG, PROTECTA XT VR D314VRG, PROTECTA DR D334DRG, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980016/S211)Medtronic Cardiac Rhythm Disease Management2011-03-25
SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS (P980016/S282)Medtronic Cardiac Rhythm Disease Management2011-03-24
THINLINE II, STEROX, FINELINE II STEROX AND FINELINE II STEROX EZ (P960004/S048)Boston Scientific2011-03-24
CONCERTO II ICD/CONSULTA/MAXIMO II CRT-DS (P010031/S237)Medtronic Cardiac Rhythm Disease Management2011-03-24
ADAPTA/VERSA/SENSIA/RELIA IPGS (P980035/S204)Medtronic, Inc.2011-03-24
STARCLOSE SE VASCULAR CLOSURE SYSTEM IFU (P050007/S028)Abbott Vascular Devices2011-03-24
ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S005)Medtronic Cryocath, LP2011-03-24
CONSULTA & SYNCRA CRT-PS IMPLANTABLE PULSE GENERATOR WITH CARDIAC RESYNCHRONIZATION (P010015/S084)Medtronic, Inc.2011-03-22
SECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS (P980016/S240)Medtronic Cardiac Rhythm Disease Management2011-03-22
ENRHYTHM (P980035/S197)Medtronic, Inc.2011-03-22
INSYNC CRT-P & INSYNC III CRT-P (P010015/S086)Medtronic, Inc.2011-03-22
CONCERTO II, CONSULTA AND MAXIMO II (P010031/S222)Medtronic Cardiac Rhythm Disease Management2011-03-22
CARELINK MONITOR MODELS 2490G/2491DDMA (P890003/S189)Medtronic, Inc.2011-03-22
REPLY/ESPRIT SR/DR PACERS (P950029/S056)MicroPort CRM USA, Inc.2011-03-22
ADAPTA/VERSA/SENSIA/RELIA IPG IMPLANTABLE PULSE GENERATOR (P980035/S147)Medtronic, Inc.2011-03-22
VITATRON DA + C-SERIESAND VITATRON DA + T-SERIES (P990001/S080)Medtronic, Inc.2011-03-22
DEMA IPG/C & T SERIES IPGS (P990001/S068)Medtronic, Inc.2011-03-22
MAXIMO II, SECURA AND VIRTUOSO II (P980016/S268)Medtronic Cardiac Rhythm Disease Management2011-03-22
KAPPA 400 DR/SR IPG (P970012/S068)Medtronic, Inc.2011-03-22
KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS (P980035/S168)Medtronic, Inc.2011-03-22
CONCERTO II/CONSULTA/MAXIMO II CRT-DS (P010031/S198)Medtronic Cardiac Rhythm Disease Management2011-03-22
CARELINK MONITOR SYSTEM (P890003/S178)Medtronic, Inc.2011-03-22
CARELINK DDMA SOFTWARE AND CARELINK MONITOR (P890003/S192)Medtronic, Inc.2011-03-22
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S070)Boston Scientific Scimed, Inc.2011-03-18
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S060)W. L. Gore & Associates, Inc.2011-03-18
MARQUIS/MAXIMO (P980016/S283)Medtronic Cardiac Rhythm Disease Management2011-03-18
TALENT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P070007/S030)Medtronic Vascular2011-03-18
ENDURANT STENT GRAFT SYSTEM (P100021/S007)Medtronic Vascular2011-03-18
MEDTRONIC REVO MRI PACEMAKER (P090013/S001)Medtronic, Inc.2011-03-18
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S059)Abbott Vascular, Inc.2011-03-18
MULTI-LINK ZETA RX CORONARY STENT SYSTEM (P970020/S061)Abbott Vascular, Inc.2011-03-18
COMPLETE SE VASCULAR STENT SYSTEM (P090006/S005)Medtronic Vascular2011-03-18
EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S010)Boston Scientific Corporation2011-03-18
MULTI-LINK VISION/MINI VISION/8TM/8TMLL/8TM SV CORONARY STENT SYSTEM (P020047/S031)Abbott Vascular2011-03-18
MULTI-LINK VISION/MINI VISION/MULTI-LINK 8TM/8TM LL/8TM SV CORONARY STENT SYSTEMS (P020047/S030)Abbott Vascular2011-03-18
KAPPA 400 (P970012/S083)Medtronic, Inc.2011-03-18
350 SERIES/ADAPTA/ENPULSE (P980035/S205)Medtronic, Inc.2011-03-18
ENDURANT STENT GRAFT SYSTEM (P100021/S006)Medtronic Vascular2011-03-18
PRODIGY IPG (P890003/S215)Medtronic, Inc.2011-03-17
STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION 2/SCORPION 2M ABLATION CATHETERS AND THE TEMPLINK/TEMPLINK M EXTENSION (P000020/S014)Boston Scientific Corp2011-03-17
SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICDS (P980016/S281)Medtronic Cardiac Rhythm Disease Management2011-03-17
INSYNC SENTRY CRT-D/CONCERTO ICD/CONSULTA CRT-D/CONCERTO II CRT-D/MAXIMO II CRT-D (P010031/S238)Medtronic Cardiac Rhythm Disease Management2011-03-17
LIFESTENT VASCULAR STENT SYSTEMS (P070014/S020)Bard Peripheral Vascular, Inc.2011-03-17
SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO ICDS (P980016/S284)Medtronic Cardiac Rhythm Disease Management2011-03-17
REVO MRI IPG (P090013/S002)Medtronic, Inc.2011-03-17
MEDTRONICS CARELINK HOME MONITOR AND CARDIOSIGHT READER (P890003/S210)Medtronic, Inc.2011-03-17
FEMORAL INTRODUCER SHEATH & HEMOSTASIS DEVICE (FISH) (P050043/S004)Morris Innovative Research, Inc.2011-03-17
MEDTRONIC CARELINK REMOTE HOME MONITOR (P890003/S195)Medtronic, Inc.2011-03-17
ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM IPGS (P980035/S206)Medtronic, Inc.2011-03-17
CONCERTO/II ICD/CONSULTA CRT-D/MAXIMO II CRT-D (P010031/S236)Medtronic Cardiac Rhythm Disease Management2011-03-17
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S034)Boston Scientific Corp2011-03-17
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S059)W. L. Gore & Associates, Inc.2011-03-16
ENDURANT STENT GRAFT SYSTEM (P100021/S005)Medtronic Vascular2011-03-16
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S038)W. L. Gore & Associates, Inc.2011-03-16
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S068)Boston Scientific Corp2011-03-11
QUICK-CLOSE VASCULAR SUTURING SYSTEM (P080029/S001)Cardiva Medical, Inc.2011-03-11
MYNX VASCULAR CLOSURE DEVICE (P040044/S036)Cordis US Corporation2011-03-10
THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S047)Thoratec Laboratories Corp.2011-03-10
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