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Cardiovascular

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

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RecordFirmDate
BJORK-SHILEY CARDIAC VALVE (P780008/S014)Shiley, Inc.1985-04-09
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S005)Telectronics Pacing Systems, Inc.1985-04-09
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S009)Advanced Cardiovascular Systems, Inc.1985-03-25
COSMOS(TM) SYSTEM (P830026/S005)Boston Scientific1985-02-27
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S007)St. Jude Medical, Inc.1985-02-27
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S013)St. Jude Medical, Inc.1985-02-27
COSMOS(TM) SYSTEM (P830026/S006)Boston Scientific1985-02-27
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S010)Medtronic Cardiac Surgery1985-02-08
COSMOS(TM) SYSTEM (P830026/S001)Boston Scientific1985-02-07
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S004)St. Jude Medical, Inc.1985-02-02
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S012)Medtronic Cardiac Rhythm Disease Management1985-02-02
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S015)Medtronic Cardiac Rhythm Disease Management1985-02-02
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
CUTANIOUS GAS MONITOR (P830008/S002)Sensor Medics Corp.1985-01-11
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S006)St. Jude Medical, Inc.1985-01-09
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S002)St. Jude Medical, Inc.1985-01-08
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S006)ABBOTT MEDICAL1985-01-08
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S010)Advanced Cardiovascular Systems, Inc.1984-11-30
BJORK-SHILEY CARDIAC VALVE (P780008/S015)Shiley, Inc.1984-11-26
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S007)Advanced Cardiovascular Systems, Inc.1984-11-21
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S008)Telectronics Pacing Systems, Inc.1984-11-19
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S003)St. Jude Medical, Inc.1984-11-19
COSMOS(TM) SYSTEM (P830026/S003)Boston Scientific1984-11-16
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S005)St. Jude Medical, Inc.1984-11-16
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S011)Advanced Cardiovascular Systems, Inc.1984-11-08
CYBERTACH(TM) 60 PULSE GENERATOR & PROGRAMMER (P820022)Boston Scientific1984-11-07
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S004)Advanced Cardiovascular Systems, Inc.1984-11-07
CUTANIOUS GAS MONITOR (P830008/S001)Sensor Medics Corp.1984-10-29
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S001)St. Jude Medical, Inc.1984-10-09
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S010)Medtronic Cardiac Rhythm Disease Management1984-09-05
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S011)Medtronic Cardiac Rhythm Disease Management1984-08-21
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S008)Advanced Cardiovascular Systems, Inc.1984-06-08
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S008)Medtronic Cardiac Rhythm Disease Management1984-06-04
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S010)St. Jude Medical, Inc.1984-05-21
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S011)St. Jude Medical, Inc.1984-05-21
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S004)ABBOTT MEDICAL1984-05-16
BJORK-SHILEY CARDIAC VALVE (P780008/S011)Shiley, Inc.1984-05-15
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S009)Medtronic Cardiac Rhythm Disease Management1984-04-27
TCPCO2 MONITORING SYSTEM (P820025/S001)Narco Scientific1984-04-18
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S005)St. Jude Medical, Inc.1984-03-23
COSMOS(TM) SYSTEM (P830026)Boston Scientific1984-03-23
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045)St. Jude Medical, Inc.1984-03-22
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S006)Telectronics Pacing Systems, Inc.1984-03-08
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S002)Telectronics Pacing Systems, Inc.1984-03-07
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S003)ABBOTT MEDICAL1984-03-01
PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P (P820023/S005)Pacesetter Systems1984-02-23
USCI GRUNTZIG DILACA CATHETER (P790017/S009)Medtronic, Ireland1984-02-22
DIPLOS MODEL 05 A & B (P820076)Biotronik, Inc.1984-02-15
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S007)Telectronics Pacing Systems, Inc.1984-02-08
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S003)Telectronics Pacing Systems, Inc.1984-02-07
USCI GRUNTZIG DILACA CATHETER (P790017/S007)Medtronic, Ireland1983-12-14
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S001)Telectronics Pacing Systems, Inc.1983-12-06
PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P (P820023/S004)Pacesetter Systems1983-11-21
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S004)Medtronic Cardiac Rhythm Disease Management1983-11-17
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S005)Medtronic Cardiac Rhythm Disease Management1983-11-17
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007)Telectronics Pacing Systems, Inc.1983-11-10
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S005)Telectronics Pacing Systems, Inc.1983-09-23
ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S002)Pacesetter Systems1983-09-20
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S007)Medtronic Cardiac Rhythm Disease Management1983-09-13
PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P (P820023/S003)Pacesetter Systems1983-08-10
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S003)Telectronics Pacing Systems, Inc.1983-07-28
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S004)Telectronics Pacing Systems, Inc.1983-07-28
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S006)Advanced Cardiovascular Systems, Inc.1983-07-26
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S003)Advanced Cardiovascular Systems, Inc.1983-07-25
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S009)St. Jude Medical, Inc.1983-07-14
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S002)ABBOTT MEDICAL1983-07-12
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S001)St. Jude Medical, Inc.1983-06-06
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S006)Medtronic Cardiac Rhythm Disease Management1983-06-03
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S006)St. Jude Medical, Inc.1983-06-03
LIFESPAN(TM) 100 TCPCO2 MONITOR (P820019/S002)Biochem International, Inc.1983-05-26
BJORK-SHILEY CARDIAC VALVE (P780008/S007)Shiley, Inc.1983-05-20
PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P (P820023/S002)Pacesetter Systems1983-05-03
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S001)ABBOTT MEDICAL1983-04-27
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S003)Medtronic Cardiac Rhythm Disease Management1983-04-22
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S002)Medtronic Cardiac Rhythm Disease Management1983-03-01
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S002)Telectronics Pacing Systems, Inc.1983-02-17
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018)St. Jude Medical, Inc.1983-02-10
PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P (P820023)Pacesetter Systems1983-02-04
ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S001)Pacesetter Systems1983-01-27
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S002)Advanced Cardiovascular Systems, Inc.1983-01-14
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S004)Medtronic Cardiac Surgery1983-01-12
USCI GRUNTZIG DILACA CATHETER (P790017/S006)Medtronic, Ireland1983-01-12
USCI GRUNTZIG DILACA CATHETER (P790017/S005)Medtronic, Ireland1982-12-27
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002)ABBOTT MEDICAL1982-12-17
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S001)Telectronics Pacing Systems, Inc.1982-11-24
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003)Medtronic Cardiac Rhythm Disease Management1982-11-16
USCI GRUNTZIG DILACA CATHETER (P790017/S004)Medtronic, Ireland1982-10-04
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S003)Medtronic Cardiac Surgery1982-09-22
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S002)Medtronic Cardiac Surgery1982-06-25
CYBERLITH IV UNIPOLAR PULSE GENERATOR (P800019/S006)Boston Scientific1982-06-25
MINI BALLOON (P780011/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-06-04
CYBERLITH IV UNIPOLAR PULSE GENERATOR (P800019/S005)Boston Scientific1982-06-01
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S001)Advanced Cardiovascular Systems, Inc.1982-04-27
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S001)Medtronic Cardiac Surgery1982-03-26
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046)Advanced Cardiovascular Systems, Inc.1982-03-03
BJORK-SHILEY CARDIAC VALVE (P780008/S005)Shiley, Inc.1982-02-05
CYBERLITH IV UNIPOLAR PULSE GENERATOR (P800019/S004)Boston Scientific1982-01-08
CYBERLITH IV UNIPOLAR PULSE GENERATOR (P800019/S003)Boston Scientific1981-12-24
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018)Medtronic Cardiac Surgery1981-12-23
MINI BALLOON (P780011/S004)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-12-18
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