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Cardiovascular

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

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RecordFirmDate
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S005)Boston Scientific1987-11-18
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S011)Medtronic, Inc.1987-11-18
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S003)Trimedyne, Inc.1987-11-18
USCI GRUNTZIG DILACA CATHETER (P790017/S015)Medtronic, Ireland1987-11-13
SCIMED PTCA DILATATION CATHETER (P860019/S003)Scimed Life Systems, Inc.1987-11-10
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S034)Medtronic Cardiac Rhythm Disease Management1987-11-02
N.C.G.T. GRAFT (P800058/S007)St. Jude Medical, Inc.1987-11-02
COSMOS(TM) SYSTEM (P830026/S030)Boston Scientific1987-10-21
COSMOS(TM) SYSTEM (P830026/S033)Boston Scientific1987-10-16
SCIMED PTCA DILATATION CATHETER (P860019/S002)Scimed Life Systems, Inc.1987-10-07
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S036)Advanced Cardiovascular Systems, Inc.1987-10-06
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S012)ABBOTT MEDICAL1987-10-05
COSMOS(TM) SYSTEM (P830026/S032)Boston Scientific1987-09-18
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S034)Advanced Cardiovascular Systems, Inc.1987-09-16
AMER, ED. LABS. PTCA (P850021/S003)Abbott Vascular, Inc.1987-09-16
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S033)Medtronic Cardiac Rhythm Disease Management1987-09-16
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S001)Trimedyne, Inc.1987-08-28
COSMOS(TM) SYSTEM (P830026/S031)Boston Scientific1987-08-21
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S033)Advanced Cardiovascular Systems, Inc.1987-08-12
COSMOS(TM) SYSTEM (P830026/S028)Boston Scientific1987-08-10
N.C.G.T. GRAFT (P800058/S005)St. Jude Medical, Inc.1987-07-30
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S032)Medtronic Cardiac Rhythm Disease Management1987-07-28
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S010)Medtronic, Inc.1987-07-28
N.C.G.T. GRAFT (P800058/S001)St. Jude Medical, Inc.1987-07-20
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S002)Trimedyne, Inc.1987-07-14
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S003)Medtronic Cardiac Rhythm Disease Management1987-06-30
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S029)Advanced Cardiovascular Systems, Inc.1987-06-26
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S031)Advanced Cardiovascular Systems, Inc.1987-06-26
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S031)Medtronic Cardiac Rhythm Disease Management1987-06-26
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S007)Medtronic, Inc.1987-06-26
MODELS 925, 2040, 2041, 6564 (P840068/S003)Boston Scientific1987-06-26
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S008)Medtronic, Inc.1987-06-26
COSMOS(TM) SYSTEM (P830026/S029)Boston Scientific1987-06-26
COSMOS(TM) SYSTEM (P830026/S026)Boston Scientific1987-06-26
COSMOS(TM) SYSTEM (P830026/S024)Boston Scientific1987-06-26
COSMOS(TM) SYSTEM (P830026/S025)Boston Scientific1987-06-26
ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S007)Pacesetter Systems1987-06-22
USCI GRUNTZIG DILACA CATHETER (P790017/S013)Medtronic, Ireland1987-06-15
USCI GRUNTZIG DILACA CATHETER (P790017/S011)Medtronic, Ireland1987-06-15
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S026)Advanced Cardiovascular Systems, Inc.1987-05-22
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S004)Medtronic Cardiac Rhythm Disease Management1987-04-30
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S021)Telectronics Pacing Systems, Inc.1987-04-08
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S030)Telectronics Pacing Systems, Inc.1987-04-03
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S031)Telectronics Pacing Systems, Inc.1987-04-03
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S027)St. Jude Medical, Inc.1987-03-27
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S020)Telectronics Pacing Systems, Inc.1987-03-27
COSMOS(TM) SYSTEM (P830026/S022)Boston Scientific1987-03-24
COSMOS(TM) SYSTEM (P830026/S023)Boston Scientific1987-03-24
SCIMED PTCA DILATATION CATHETER (P860019/S001)Scimed Life Systems, Inc.1987-03-13
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S025)Advanced Cardiovascular Systems, Inc.1987-03-05
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S030)Medtronic Cardiac Rhythm Disease Management1987-03-02
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042)Trimedyne, Inc.1987-02-27
MAESTRO SERIES 500 P.G. MODELS 501, 505, 509 (P860027)Cardiac Control Systems, Inc.1987-02-27
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S027)Telectronics Pacing Systems, Inc.1987-02-18
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S011)St. Jude Medical, Inc.1987-02-13
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S029)Medtronic Cardiac Rhythm Disease Management1987-02-10
COSMOS(TM) SYSTEM (P830026/S020)Boston Scientific1987-02-10
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S027)Advanced Cardiovascular Systems, Inc.1987-02-03
COSMOS(TM) SYSTEM (P830026/S019)Boston Scientific1987-02-03
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S029)Telectronics Pacing Systems, Inc.1987-02-03
COSMOS(TM) SYSTEM (P830026/S021)Boston Scientific1987-02-03
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S003)Medtronic, Inc.1987-02-03
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S019)Telectronics Pacing Systems, Inc.1987-01-30
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S002)Medtronic, Inc.1987-01-09
AMER, ED. LABS. PTCA (P850021/S001)Abbott Vascular, Inc.1987-01-08
INTERTACH TM IMPLANTABLE PACEMAKER PULSE (P860007)Boston Scientific1986-12-31
ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7 (P860008)Cardio Command1986-12-30
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S018)Telectronics Pacing Systems, Inc.1986-12-01
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S028)Telectronics Pacing Systems, Inc.1986-12-01
SCIMED PTCA DILATATION CATHETER (P860019)Scimed Life Systems, Inc.1986-11-28
MODEL 5525 TRANSVENOUS ATRAIL & MODEL 5025 VENTRIC (P850089/S001)Medtronic Cardiac Rhythm Disease Management1986-11-24
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S009)ABBOTT MEDICAL1986-11-24
MODEL 515 NEONATAL MONIOTR (P840037/S001)Ge Medical Systems Information Technologies1986-11-19
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S002)Medtronic Cardiac Rhythm Disease Management1986-10-31
BJORK-SHILEY CARDIAC VALVE (P780008/S013)Shiley, Inc.1986-10-31
USCI{R} SLIDEWIRE{TM} STEERABLE GUIDE WIRES (P790017/S012)Medtronic, Ireland1986-10-31
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S026)Telectronics Pacing Systems, Inc.1986-10-20
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S017)Telectronics Pacing Systems, Inc.1986-10-20
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S026)St. Jude Medical, Inc.1986-10-10
MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525 (P850089/S003)Medtronic Cardiac Rhythm Disease Management1986-10-07
PLUS XX AND PROFILE PLUS (P790017/S008)Medtronic, Ireland1986-10-07
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S004)Boston Scientific1986-10-03
TELECTRONICS PASAR MODEL 4171 PG (P850027)Telectronics, Inc.1986-09-30
STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING (P830061/S001)Medtronic Cardiac Rhythm Disease Management1986-09-25
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S003)Boston Scientific1986-09-25
MODEL 5525 TRANSVENOUS ATRAIL & MODEL 5025 VENTRIC (P850089/S002)Medtronic Cardiac Rhythm Disease Management1986-09-25
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S005)Medtronic, Inc.1986-09-10
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S006)Medtronic, Inc.1986-09-10
COSMOS(TM) SYSTEM (P830026/S016)Boston Scientific1986-09-10
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S004)Medtronic, Inc.1986-09-04
ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S006)Pacesetter Systems1986-09-02
DUROMEDICS BILEAFLET HEART VALVE (P850006)Edwards Lifesciences, LLC1986-08-29
COSMOS(TM) SYSTEM (P830026/S017)Boston Scientific1986-08-28
COSMOS(TM) SYSTEM (P830026/S015)Boston Scientific1986-08-28
COSMOS(TM) SYSTEM (P830026/S018)Boston Scientific1986-08-28
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S023)Advanced Cardiovascular Systems, Inc.1986-08-25
DDD PULSE GENERATOR 674 (P840014)Pacesetter Systems1986-07-31
STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING (P830061)Medtronic Cardiac Rhythm Disease Management1986-07-29
CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS (P850089)Medtronic Cardiac Rhythm Disease Management1986-07-29
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S024)Advanced Cardiovascular Systems, Inc.1986-07-17
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