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Cardiovascular

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

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RecordFirmDate
COSMOS(TM) SYSTEM (P830026/S036)Boston Scientific1988-10-24
MAESTRO SERIES 500 P.G. MODELS 501, 505, 509 (P860027/S003)Cardiac Control Systems, Inc.1988-10-18
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
PRIME{TM} MODEL 6520, 6525, 6530 AND 6535 (P870021/S001)Medtronic, Inc.1988-10-13
MODELS 925, 2040, 2041, 6564 (P840068/S007)Boston Scientific1988-10-07
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S005)Trimedyne, Inc.1988-10-07
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S023)St. Jude Medical, Inc.1988-09-26
SCIMED PTCA DILATATION CATHETER (P860019/S012)Scimed Life Systems, Inc.1988-09-23
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S045)Advanced Cardiovascular Systems, Inc.1988-09-23
DIPLOS MODEL 03 (P820076/S005)Biotronik, Inc.1988-09-09
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S014)St. Jude Medical, Inc.1988-09-08
SCIMED PTCA DILATATION CATHETER (P860019/S013)Scimed Life Systems, Inc.1988-08-31
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S009)Boston Scientific Corp1988-08-31
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S032)Advanced Cardiovascular Systems, Inc.1988-08-22
OMNISCEINCE PROSTHETIC CARDIAC VALVE (P830039/S002)Medical Cv, Inc.1988-08-18
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S016)Medtronic, Inc.1988-08-11
VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM (P870036/S001)Medtronics Interventional Vascular1988-08-10
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S008)Boston Scientific Corp1988-08-10
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S013)St. Jude Medical, Inc.1988-08-10
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S027)Telectronics Pacing Systems, Inc.1988-08-04
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S037)Telectronics Pacing Systems, Inc.1988-08-04
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S026)Telectronics Pacing Systems, Inc.1988-08-04
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S036)Telectronics Pacing Systems, Inc.1988-07-28
ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7 (P860008/S003)Cardio Command1988-07-27
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S006)Boston Scientific1988-07-25
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S028)St. Jude Medical, Inc.1988-07-25
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S038)Telectronics Pacing Systems, Inc.1988-07-21
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S028)Telectronics Pacing Systems, Inc.1988-07-21
SCIMED PTCA DILATATION CATHETER (P860019/S009)Scimed Life Systems, Inc.1988-07-18
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S012)Medtronic, Inc.1988-07-15
SCIMED PTCA DILATATION CATHETER (P860019/S007)Scimed Life Systems, Inc.1988-07-12
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S015)Medtronic, Inc.1988-07-12
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S048)Advanced Cardiovascular Systems, Inc.1988-07-11
MODELS 925, 2040, 2041, 6564 (P840068/S005)Boston Scientific1988-07-07
SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043)Trimedyne, Inc.1988-06-30
SCIMED PTCA DILATATION CATHETER (P860019/S010)Scimed Life Systems, Inc.1988-06-27
SCIMED PTCA DILATATION CATHETER (P860019/S011)Scimed Life Systems, Inc.1988-06-27
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S046)Advanced Cardiovascular Systems, Inc.1988-06-27
AMER, ED. LABS. PTCA (P850021/S005)Abbott Vascular, Inc.1988-06-22
ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7 (P860008/S002)Cardio Command1988-06-17
N.C.G.T. GRAFT (P800058/S006)St. Jude Medical, Inc.1988-06-14
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S004)Trimedyne, Inc.1988-06-14
USCI GRUNTZIG DILACA CATHETER (P790017/S021)Medtronic, Ireland1988-06-09
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S005)Boston Scientific Corp1988-06-09
USCI GRUNTZIG DILACA CATHETER (P790017/S018)Medtronic, Ireland1988-06-07
AMER, ED. LABS. PTCA (P850021/S004)Abbott Vascular, Inc.1988-06-06
USCI GRUNTZIG DILACA CATHETER (P790017/S020)Medtronic, Ireland1988-05-24
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S006)Boston Scientific Corp1988-05-24
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S015)ABBOTT MEDICAL1988-05-18
SCIMED PTCA DILATATION CATHETER (P860019/S006)Scimed Life Systems, Inc.1988-05-18
SCIMED PTCA DILATATION CATHETER (P860019/S008)Scimed Life Systems, Inc.1988-05-18
USCI GRUNTZIG DILACA CATHETER (P790017/S019)Medtronic, Ireland1988-05-17
DIPLOS MODEL 03 (P820076/S004)Biotronik, Inc.1988-05-17
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S013)Medtronic Cardiac Surgery1988-05-09
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S014)Medtronic Cardiac Surgery1988-05-09
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S037)Medtronic Cardiac Rhythm Disease Management1988-05-09
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S013)Medtronic, Inc.1988-05-09
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054)Cook Pacemaker Corp.1988-04-29
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S043)Advanced Cardiovascular Systems, Inc.1988-04-22
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S044)Advanced Cardiovascular Systems, Inc.1988-04-22
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S036)Medtronic Cardiac Rhythm Disease Management1988-04-21
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S014)Medtronic, Inc.1988-04-21
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S004)Boston Scientific Corp1988-04-20
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S035)Medtronic Cardiac Rhythm Disease Management1988-04-14
MODELS 925, 2040, 2041, 6564 (P840068/S004)Boston Scientific1988-04-12
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S035)Telectronics Pacing Systems, Inc.1988-04-12
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S024)Telectronics Pacing Systems, Inc.1988-04-12
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S023)Telectronics Pacing Systems, Inc.1988-04-06
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S033)Telectronics Pacing Systems, Inc.1988-04-06
VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM (P870036)Medtronics Interventional Vascular1988-03-25
MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525 (P850089/S007)Medtronic Cardiac Rhythm Disease Management1988-03-21
USCI GRUNTZIG DILACA CATHETER (P790017/S017)Medtronic, Ireland1988-03-18
ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7 (P860008/S001)Cardio Command1988-03-17
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S041)Advanced Cardiovascular Systems, Inc.1988-03-17
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S034)Telectronics Pacing Systems, Inc.1988-03-17
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S038)Advanced Cardiovascular Systems, Inc.1988-03-17
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S025)Telectronics Pacing Systems, Inc.1988-03-17
SCIMED PTCA DILATATION CATHETER (P860019/S004)Scimed Life Systems, Inc.1988-03-07
AMER, ED. LABS. PTCA (P850021/S002)Abbott Vascular, Inc.1988-03-02
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S001)Medtronic, Inc.1988-03-02
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S014)ABBOTT MEDICAL1988-02-29
CUTANIOUS GAS MONITOR (P830008/S003)Sensor Medics Corp.1988-02-29
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S005)Medtronic Cardiac Rhythm Disease Management1988-02-29
PRIME{TM} MODEL 6520, 6525, 6530 AND 6535 (P870021)Medtronic, Inc.1988-02-29
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S042)Advanced Cardiovascular Systems, Inc.1988-02-29
MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525 (P850089/S004)Medtronic Cardiac Rhythm Disease Management1988-02-26
USCI GRUNTZIG DILACA CATHETER (P790017/S016)Medtronic, Ireland1988-02-19
SCIMED PTCA DILATATION CATHETER (P860019/S005)Scimed Life Systems, Inc.1988-02-19
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S003)Boston Scientific Corp1988-02-19
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S039)Advanced Cardiovascular Systems, Inc.1988-02-02
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S040)Advanced Cardiovascular Systems, Inc.1988-02-02
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S035)Advanced Cardiovascular Systems, Inc.1988-01-29
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S016)ABBOTT MEDICAL1988-01-20
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S022)Telectronics Pacing Systems, Inc.1988-01-11
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S032)Telectronics Pacing Systems, Inc.1988-01-11
MAESTRO SERIES 500 P.G. MODELS 501, 505, 509 (P860027/S001)Cardiac Control Systems, Inc.1987-12-22
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S008)ABBOTT MEDICAL1987-12-11
MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525 (P850089/S005)Medtronic Cardiac Rhythm Disease Management1987-12-03
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S011)ABBOTT MEDICAL1987-12-03
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