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Cardiovascular

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

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RecordFirmDate
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S028)Medtronic Cardiac Rhythm Disease Management1986-07-17
N.C.G.T. GRAFT (P800058/S003)St. Jude Medical, Inc.1986-07-11
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S002)Boston Scientific Corp1986-07-11
MODELS 925, 2040, 2041, 6564 (P840068/S002)Boston Scientific1986-06-30
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S027)Medtronic Cardiac Rhythm Disease Management1986-06-30
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051)Medtronic, Inc.1986-06-10
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S005)Medtronic Cardiac Surgery1986-06-03
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S002)Boston Scientific1986-06-03
AMER, ED. LABS. PTCA (P850021)Abbott Vascular, Inc.1986-05-30
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S021)Advanced Cardiovascular Systems, Inc.1986-05-23
DARDIK BIOGRAFT (P780002/S005)Synovis Surgical Innovations1986-05-19
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S024)Medtronic Cardiac Rhythm Disease Management1986-05-07
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S025)Telectronics Pacing Systems, Inc.1986-05-05
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S012)Telectronics Pacing Systems, Inc.1986-05-05
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S006)Telectronics Pacing Systems, Inc.1986-05-05
STAT-PACE II (P840002)Cardiocommand, Inc.1986-04-30
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S026)Medtronic Cardiac Rhythm Disease Management1986-04-25
MODELS 925, 2040, 2041, 6564 (P840068/S001)Boston Scientific1986-04-15
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S022)Medtronic Cardiac Rhythm Disease Management1986-03-27
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S020)Advanced Cardiovascular Systems, Inc.1986-03-27
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S025)St. Jude Medical, Inc.1986-03-27
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S025)Medtronic Cardiac Rhythm Disease Management1986-03-27
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S019)Advanced Cardiovascular Systems, Inc.1986-03-27
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S024)St. Jude Medical, Inc.1986-03-27
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S001)Boston Scientific1986-03-27
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S001)Boston Scientific Corp1986-03-25
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S016)Telectronics Pacing Systems, Inc.1986-03-14
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S023)Telectronics Pacing Systems, Inc.1986-03-14
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S024)Telectronics Pacing Systems, Inc.1986-03-11
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S014)Telectronics Pacing Systems, Inc.1986-03-11
DIPLOS MODEL 03 (P820076/S003)Biotronik, Inc.1986-03-06
COSMOS(TM) SYSTEM (P830026/S014)Boston Scientific1986-03-06
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S016)Advanced Cardiovascular Systems, Inc.1986-03-06
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S015)Advanced Cardiovascular Systems, Inc.1986-03-06
LIFESPAN(TM) 100 TCPCO2 MONITOR (P820019/S007)Biochem International, Inc.1986-03-03
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S023)Medtronic Cardiac Rhythm Disease Management1986-02-26
COSMOS(TM) SYSTEM (P830026/S002)Boston Scientific1986-02-12
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S022)Telectronics Pacing Systems, Inc.1986-02-12
ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S005)Pacesetter Systems1986-02-12
DIPLOS MODEL 03 (P820076/S001)Biotronik, Inc.1986-02-12
COSMOS(TM) SYSTEM (P830026/S013)Boston Scientific1986-02-12
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S015)Telectronics Pacing Systems, Inc.1986-02-12
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S020)St. Jude Medical, Inc.1986-01-30
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S022)St. Jude Medical, Inc.1986-01-30
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S021)St. Jude Medical, Inc.1986-01-28
LIFESPAN(TM) 100 TCPCO2 MONITOR (P820019/S006)Biochem International, Inc.1986-01-27
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S018)Advanced Cardiovascular Systems, Inc.1986-01-09
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S020)Telectronics Pacing Systems, Inc.1985-12-30
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S017)St. Jude Medical, Inc.1985-12-27
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S016)St. Jude Medical, Inc.1985-12-26
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040)Boston Scientific Corp1985-12-19
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S017)Advanced Cardiovascular Systems, Inc.1985-12-12
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S006)Medtronic Cardiac Surgery1985-12-05
DELTA PACEMAKER SYS; VIGOR DDD MODEL 950 (P840068)Boston Scientific1985-11-27
DIPLOS MODEL 03 (P820076/S002)Biotronik, Inc.1985-11-21
LIFESPAN(TM) 100 TCPCO2 MONITOR (P820019/S005)Biochem International, Inc.1985-11-19
COSMOS(TM) SYSTEM (P830026/S012)Boston Scientific1985-11-05
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S021)Telectronics Pacing Systems, Inc.1985-11-05
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S021)Medtronic Cardiac Rhythm Disease Management1985-11-05
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S008)Medtronic Cardiac Surgery1985-11-01
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S013)Telectronics Pacing Systems, Inc.1985-10-21
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S016)Medtronic Cardiac Rhythm Disease Management1985-10-10
VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS (P830060)Boston Scientific1985-10-04
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S019)St. Jude Medical, Inc.1985-10-01
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S009)St. Jude Medical, Inc.1985-09-26
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S007)Medtronic Cardiac Surgery1985-09-24
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S012)Medtronic Cardiac Surgery1985-09-24
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S014)Advanced Cardiovascular Systems, Inc.1985-09-10
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S012)Advanced Cardiovascular Systems, Inc.1985-09-10
CYBERLITH IV UNIPOLAR PULSE GENERATOR (P800019/S009)Boston Scientific1985-08-29
LIFESPAN(TM) MODEL 4110 TCPO2/CO2 MONITORING SYSTE (P820019/S003)Biochem International, Inc.1985-08-21
COSMOS(TM) SYSTEM (P830026/S011)Boston Scientific1985-08-14
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S012)Telectronics Pacing Systems, Inc.1985-08-12
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S019)Telectronics Pacing Systems, Inc.1985-08-12
COSMOS(TM) SYSTEM (P830026/S010)Boston Scientific1985-08-05
CYBERTACH(TM) 60 PULSE GENERATOR & PROGRAMMER (P820022/S001)Boston Scientific1985-07-29
CYBERLITH IV UNIPOLAR PULSE GENERATOR (P800019/S008)Boston Scientific1985-07-29
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S018)St. Jude Medical, Inc.1985-07-15
COSMOS(TM) SYSTEM (P830026/S009)Boston Scientific1985-07-11
NOVA(TM) PULSE GENERATOR 7 RX 2000(TM) PROGRAMMER (P830026/S008)Boston Scientific1985-07-11
COSMOS(TM) SYSTEM (P830026/S007)Boston Scientific1985-07-10
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S010)Telectronics Pacing Systems, Inc.1985-06-25
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S009)Telectronics Pacing Systems, Inc.1985-06-25
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S009)Telectronics Pacing Systems, Inc.1985-06-19
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S008)St. Jude Medical, Inc.1985-06-19
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S017)Telectronics Pacing Systems, Inc.1985-06-11
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S010)Telectronics Pacing Systems, Inc.1985-06-10
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S004)Telectronics Pacing Systems, Inc.1985-06-10
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS (P790007/S007)Medtronic Heart Valves1985-05-30
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S019)Medtronic Cardiac Rhythm Disease Management1985-05-17
OMNISCEINCE PROSTHETIC CARDIAC VALVE (P830039)Medical Cv, Inc.1985-05-03
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S013)Medtronic Cardiac Rhythm Disease Management1985-04-22
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S017)Medtronic Cardiac Rhythm Disease Management1985-04-22
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S018)Medtronic Cardiac Rhythm Disease Management1985-04-22
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S014)St. Jude Medical, Inc.1985-04-18
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S012)St. Jude Medical, Inc.1985-04-18
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S007)Telectronics Pacing Systems, Inc.1985-04-17
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S015)Telectronics Pacing Systems, Inc.1985-04-17
ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S003)Pacesetter Systems1985-04-12
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S014)Telectronics Pacing Systems, Inc.1985-04-09
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