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Cardiovascular

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

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RecordFirmDate
MODEL 6836 Y CONNECTOR (AID B/BR) (P830060/S018)Boston Scientific1990-04-20
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043/S008)Trimedyne, Inc.1990-04-04
SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM (P880006/S006)St. Jude Medical, Inc.1990-04-03
AMER, ED. LABS. PTCA (P850021/S007)Abbott Vascular, Inc.1990-04-03
SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM (P880006/S001)St. Jude Medical, Inc.1990-04-03
LEOCOR,INC. MODELS 1 (P890001)Leocor, Inc.1990-03-30
VENTAK 1550 PULSE GENERATOR (P830060/S016)Boston Scientific1990-03-30
MODEL 283 PULSE GENERATOR MODEL 370 PROGRAMMER (P830045/S024)St. Jude Medical, Inc.1990-03-30
MAESTRO SERIES 500 P.G.& MODEL 1006 PACEMAKER PROG (P860027/S004)Cardiac Control Systems, Inc.1990-03-28
MODELS 4004/4504 PACING LEADS (P830061/S011)Medtronic Cardiac Rhythm Disease Management1990-03-28
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S016)Medtronic Cardiac Surgery1990-03-27
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S030)Telectronics Pacing Systems, Inc.1990-03-22
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S042)Telectronics Pacing Systems, Inc.1990-03-22
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S035)St. Jude Medical, Inc.1990-03-22
META DDD MODEL 1230 PACER (P880038/S008)St. Jude Medical, Inc.1990-03-22
KELVIN (R) PACING SYSTEM (P870054/S011)Cook Pacemaker Corp.1990-03-19
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S008)Trimedyne, Inc.1990-03-09
UNIPOLAR IS-1 CONNECTOR RECEPTACLE MODEL (P850051/S023)Medtronic, Inc.1990-03-06
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S022)Trimedyne, Inc.1990-03-06
CORDIS STEERABLE PTCA BALLOON CATHETER (P890032)Cordis Corp.1990-03-06
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S063)Advanced Cardiovascular Systems, Inc.1990-03-06
ACS HATZLER MICRO-600 DILATATION CATHETER (P810046/S069)Advanced Cardiovascular Systems, Inc.1990-02-28
ACS R STACK PERFUSION DILATATION CATHETER (P810046/S068)Advanced Cardiovascular Systems, Inc.1990-02-27
MODEL 446 & 447 VISTA T PU.GEN. MODEL 2046 SOF.MOD (P840068/S011)Boston Scientific1990-02-21
ACS PINKERTON .018 CORONARY DILATATION BALLOON CA (P810046/S066)Advanced Cardiovascular Systems, Inc.1990-02-21
INTERTACH TM IMPLANTABLE PACEMAKER PULSE (P860007/S004)Boston Scientific1990-02-16
COSMOS(TM) SYSTEM (P830026/S039)Boston Scientific1990-02-16
CYBERLITH IV UNIPOLAR PULSE GENERATOR (P800019/S010)Boston Scientific1990-02-16
CYBERTACH(TM) 60 PULSE GENERATOR & PROGRAMMER (P820022/S002)Boston Scientific1990-02-16
INTERTACH TM IMPLANTABLE PACEMAKER PULSE (P860007/S003)Boston Scientific1990-02-13
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S021)Trimedyne, Inc.1990-02-09
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S013)Boston Scientific Corp1990-02-07
VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM (P870036/S006)Medtronics Interventional Vascular1990-02-07
~RMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S059)Advanced Cardiovascular Systems, Inc.1990-02-07
SCIMED PTCA DILATATION CATHETER (P860019/S023)Scimed Life Systems, Inc.1990-02-06
SCIMED PTCA DILATATION CATHETER (P860019/S022)Scimed Life Systems, Inc.1990-02-06
SCIMED PTCA DILATATION CATHETER (P860019/S024)Scimed Life Systems, Inc.1990-02-06
META DDD MODEL 1230 PACER (P880038/S010)St. Jude Medical, Inc.1990-02-02
AURORA MODELS 6291 & 6292 MULTIPROGRAM. DDD P. GEN (P820018/S041)St. Jude Medical, Inc.1990-02-02
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S031)Telectronics Pacing Systems, Inc.1990-02-02
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S043)Telectronics Pacing Systems, Inc.1990-02-02
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S020)Trimedyne, Inc.1990-02-01
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S011)Boston Scientific1990-01-25
META-MV,PACING SYSTEM (P880038/S003)St. Jude Medical, Inc.1990-01-23
SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM (P880006/S005)St. Jude Medical, Inc.1990-01-18
MODEL 9710E ENHEANCED PROGRAMMING SYSTEM (P820003/S047)Medtronic Cardiac Rhythm Disease Management1990-01-18
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S023)Trimedyne, Inc.1990-01-18
DIPLOS MODEL 03 (P820076/S008)Biotronik, Inc.1990-01-18
SYSNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (P890003/S002)Medtronic, Inc.1990-01-18
SYNCHRONY II MODELS 2022T & 2023M - 2002T & 2003M (P880086/S005)ABBOTT MEDICAL1990-01-18
PINKERTON .018(TM) COMPOSITE DILATATION CATHETER (P810046/S058)Advanced Cardiovascular Systems, Inc.1990-01-18
UNIPOLAR IS-1 CONNECTOR RECEPTACLE MODEL (P850051/S024)Medtronic, Inc.1990-01-18
MODEL 283 PULSE GENERATOR MODEL 370 PROGRAMMER (P830045/S025)St. Jude Medical, Inc.1990-01-18
MODEL 6577 STERILIZABLE TELEMETRY WAND (P830060/S012)Boston Scientific1990-01-11
MODEL 6577 STERILIZABLE TELEMETY WAND (P840068/S009)Boston Scientific1990-01-11
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S010)Boston Scientific1990-01-05
SYSNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (P890003/S001)Medtronic, Inc.1990-01-04
MODEL 9710E ENHEANCED PROGRAMMING SYSTEM (P820003/S046)Medtronic Cardiac Rhythm Disease Management1990-01-04
VENTAK 1550 PULSE GENERATOR (P830060/S013)Boston Scientific1990-01-04
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S034)St. Jude Medical, Inc.1989-12-28
MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525 (P850089/S009)Medtronic Cardiac Rhythm Disease Management1989-12-19
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S064)Advanced Cardiovascular Systems, Inc.1989-12-14
USCI GRUNTZIG DILACA CATHETER (P790017/S027)Medtronic, Ireland1989-12-14
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S012)Boston Scientific Corp1989-12-14
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043/S009)Trimedyne, Inc.1989-12-13
ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7 (P860008/S008)Cardio Command1989-12-06
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S005)Cook Pacemaker Corp.1989-12-06
DIPLOS MODEL 03 (P820076/S007)Biotronik, Inc.1989-12-04
SCIMED PTCA DILATATION CATHETER (P860019/S020)Scimed Life Systems, Inc.1989-12-04
SCIMED PTCA DILATATION CATHETER (P860019/S021)Scimed Life Systems, Inc.1989-12-01
SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043/S002)Trimedyne, Inc.1989-11-30
HEART VALVE (P810002/S013)ABBOTT MEDICAL1989-11-30
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S017)ABBOTT MEDICAL1989-11-30
SYNERGYST PULSE GENERATORS MODEL 7026/7027 (P820003/S043)Medtronic Cardiac Rhythm Disease Management1989-11-16
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS (P790007/S009)Medtronic Heart Valves1989-11-14
HANCOCK I BIOPROSTHESIS (P870078/S001)Medtronic, Inc.1989-11-09
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S011)Boston Scientific Corp1989-11-01
MODEL 9710E ENHEANCED PROGRAMMING SYSTEM (P820003/S045)Medtronic Cardiac Rhythm Disease Management1989-10-30
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
LEGEND MODELS 8416/8417/8418,ST MODELS 8406/8407 (P850051/S022)Medtronic, Inc.1989-10-18
INTERTACH TM IMPLANTABLE PACEMAKER PULSE (P860007/S002)Boston Scientific1989-10-16
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S062)Advanced Cardiovascular Systems, Inc.1989-10-16
META-MV,PACING SYSTEM (P880038/S005)St. Jude Medical, Inc.1989-10-16
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S061)Advanced Cardiovascular Systems, Inc.1989-09-29
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S060)Advanced Cardiovascular Systems, Inc.1989-09-29
HANCOCK PORCINE BIOPROSTHESIS (P870078)Medtronic, Inc.1989-09-28
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S021)Medtronic, Inc.1989-09-26
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043/S004)Trimedyne, Inc.1989-09-26
USCI GRUNTZIG DILACA CATHETER (P790017/S028)Medtronic, Ireland1989-09-19
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S003)Cook Pacemaker Corp.1989-09-19
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S020)St. Jude Medical, Inc.1989-09-19
SYNCHRONY MODEL 2020T PULSE GENERATOR (P880086/S002)ABBOTT MEDICAL1989-09-18
USCI GRUNTZIG DILACA CATHETER (P790017/S031)Medtronic, Ireland1989-09-14
META-MV,PACING SYSTEM (P880038/S004)St. Jude Medical, Inc.1989-09-14
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S033)St. Jude Medical, Inc.1989-09-13
MICROSOFTRAC TM (PTCA) CATHETER (P880027/S002)Boston Scientific1989-09-13
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S057)Advanced Cardiovascular Systems, Inc.1989-09-11
SYNERGYST PULSE GENERATORS MODEL 7026/7027 (P820003/S044)Medtronic Cardiac Rhythm Disease Management1989-09-06
PRIME{TM} MODEL 6520, 6525, 6530 AND 6535 (P870021/S003)Medtronic, Inc.1989-09-05
SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM (P880006/S002)St. Jude Medical, Inc.1989-08-29
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