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Cardiovascular

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

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RecordFirmDate
SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (P890003)Medtronic, Inc.1989-08-24
ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS (P880086)ABBOTT MEDICAL1989-08-21
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S019)St. Jude Medical, Inc.1989-08-17
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S008)Boston Scientific1989-08-15
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S015)Trimedyne, Inc.1989-08-08
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S032)St. Jude Medical, Inc.1989-08-08
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S006)Cook Pacemaker Corp.1989-07-31
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S020)Medtronic, Inc.1989-07-31
META-MV,PACING SYSTEM (P880038/S002)St. Jude Medical, Inc.1989-07-27
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S014)Trimedyne, Inc.1989-07-21
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S055)Advanced Cardiovascular Systems, Inc.1989-07-20
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S013)Trimedyne, Inc.1989-07-20
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043/S006)Trimedyne, Inc.1989-07-20
VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM (P870036/S005)Medtronics Interventional Vascular1989-06-23
MICROSOFTRAC TM (PTCA) CATHETER (P880027/S001)Boston Scientific1989-06-23
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S008)Medtronic Cardiac Rhythm Disease Management1989-06-23
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S004)Cook Pacemaker Corp.1989-06-20
VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM (P870036/S004)Medtronics Interventional Vascular1989-06-20
ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S008)Pacesetter Systems1989-06-19
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S019)Trimedyne, Inc.1989-06-09
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S011)Trimedyne, Inc.1989-06-09
USCI GRUNTZIG DILACA CATHETER (P790017/S026)Medtronic, Ireland1989-06-07
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S012)Trimedyne, Inc.1989-06-06
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S016)Trimedyne, Inc.1989-06-06
VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM (P870036/S003)Medtronics Interventional Vascular1989-06-06
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043/S005)Trimedyne, Inc.1989-06-06
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S051)Advanced Cardiovascular Systems, Inc.1989-05-22
INTERTACH TM IMPLANTABLE PACEMAKER PULSE (P860007/S001)Boston Scientific1989-05-22
META-MV,PACING SYSTEM (P880038/S001)St. Jude Medical, Inc.1989-05-10
COSMOS(TM) SYSTEM (P830026/S038)Boston Scientific1989-05-05
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S010)Trimedyne, Inc.1989-05-01
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S018)St. Jude Medical, Inc.1989-05-01
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S010)Boston Scientific Corp1989-05-01
MICROVEL(R) WITH HEMASHIELD (P840029)Maquet Cardiovascular, LLC1989-04-26
COOK BIRD'S NEST VENA CAVA FILTER (P850049)Cook, Inc.1989-04-26
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S009)Medtronic Cardiac Rhythm Disease Management1989-04-26
MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525 (P850089/S011)Medtronic Cardiac Rhythm Disease Management1989-04-26
MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525 (P850089/S010)Medtronic Cardiac Rhythm Disease Management1989-04-20
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S009)Trimedyne, Inc.1989-04-19
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043/S003)Trimedyne, Inc.1989-04-19
VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM (P870036/S002)Medtronics Interventional Vascular1989-04-19
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S041)Telectronics Pacing Systems, Inc.1989-04-18
ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7 (P860008/S007)Cardio Command1989-04-18
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S031)St. Jude Medical, Inc.1989-04-18
PRIME{TM} MODEL 6520, 6525, 6530 AND 6535 (P870021/S002)Medtronic, Inc.1989-04-18
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S029)Telectronics Pacing Systems, Inc.1989-04-18
MICROSOFTRAC TM (PTCA) CATHETER (P880027)Boston Scientific1989-04-14
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S016)St. Jude Medical, Inc.1989-04-13
SYNERGYST PULSE GENERATORS MODEL 7026/7027 (P820003/S042)Medtronic Cardiac Rhythm Disease Management1989-04-13
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S017)St. Jude Medical, Inc.1989-04-13
META-MV,PACING SYSTEM (P880038)St. Jude Medical, Inc.1989-04-07
LASTAC SYSTEM (P870071/S003)G V Medical, Inc.1989-04-06
LASTAC SYSTEM (P870071/S002)G V Medical, Inc.1989-04-04
CORDIS PTCA DILATATION CATHETER (P880003/S003)Cordis Corp.1989-03-31
LASTAC SYSTEM (P870071/S005)G V Medical, Inc.1989-03-31
LASTAC SYSTEM (P870071/S004)G V Medical, Inc.1989-03-30
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S001)Cook Pacemaker Corp.1989-03-29
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S002)Cook Pacemaker Corp.1989-03-22
SCIMED PTCA DILATATION CATHETER (P860019/S017)Scimed Life Systems, Inc.1989-03-20
SCIMED PTCA DILATATION CATHETER (P860019/S019)Scimed Life Systems, Inc.1989-03-13
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S015)St. Jude Medical, Inc.1989-03-09
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S053)Advanced Cardiovascular Systems, Inc.1989-03-09
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S054)Advanced Cardiovascular Systems, Inc.1989-03-09
SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM (P880006)St. Jude Medical, Inc.1989-02-28
SCIMED PTCA DILATATION CATHETER (P860019/S018)Scimed Life Systems, Inc.1989-02-24
DIPLOS MODEL 03 (P820076/S006)Biotronik, Inc.1989-02-22
SCIMED PTCA DILATATION CATHETER (P860019/S016)Scimed Life Systems, Inc.1989-02-21
MODELS 925, 2040, 2041, 6564 (P840068/S006)Boston Scientific1989-02-21
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S006)Medtronic Cardiac Rhythm Disease Management1989-02-10
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S006)Trimedyne, Inc.1989-02-09
SYNERGYST PULSE GENERATORS MODEL 7026/7027 (P820003/S040)Medtronic Cardiac Rhythm Disease Management1989-02-06
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S007)Medtronic Cardiac Rhythm Disease Management1989-02-06
SYNERGYST PULSE GENERATORS MODEL 7026/7027 (P820003/S041)Medtronic Cardiac Rhythm Disease Management1989-02-06
MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525 (P850089/S008)Medtronic Cardiac Rhythm Disease Management1989-02-03
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S050)Advanced Cardiovascular Systems, Inc.1989-02-02
LASTAC SYSTEM (P870071/S001)G V Medical, Inc.1989-02-02
AMER, ED. LABS. PTCA (P850021/S006)Abbott Vascular, Inc.1989-02-02
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S052)Advanced Cardiovascular Systems, Inc.1989-01-27
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S029)St. Jude Medical, Inc.1989-01-27
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S007)Trimedyne, Inc.1989-01-24
N.C.G.T. GRAFT (P800058/S008)St. Jude Medical, Inc.1989-01-19
USCI GRUNTZIG DILACA CATHETER (P790017/S025)Medtronic, Ireland1989-01-19
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S047)Advanced Cardiovascular Systems, Inc.1989-01-11
CORDIS PTCA DILATATION CATHETER (P880003/S001)Cordis Corp.1989-01-11
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S038)Medtronic Cardiac Rhythm Disease Management1988-12-29
MAESTRO SERIES 500 P.G. MODELS 501, 505, 509 (P860027/S002)Cardiac Control Systems, Inc.1988-12-28
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S049)Advanced Cardiovascular Systems, Inc.1988-12-28
ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7 (P860008/S005)Cardio Command1988-12-27
SCIMED PTCA DILATATION CATHETER (P860019/S014)Scimed Life Systems, Inc.1988-12-21
SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043/S001)Trimedyne, Inc.1988-12-15
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S039)Telectronics Pacing Systems, Inc.1988-12-12
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S039)Medtronic Cardiac Rhythm Disease Management1988-12-12
COSMOS(TM) SYSTEM (P830026/S037)Boston Scientific1988-11-23
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S017)Medtronic, Inc.1988-11-23
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S007)Boston Scientific1988-11-08
MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525 (P850089/S006)Medtronic Cardiac Rhythm Disease Management1988-11-03
CORDIS PTCA DILATATION CATHETER (P880003)Cordis Corp.1988-10-28
SCIMED PTCA DILATATION CATHETER (P860019/S015)Scimed Life Systems, Inc.1988-10-24
COSMOS(TM) SYSTEM (P830026/S034)Boston Scientific1988-10-24
COSMOS(TM) SYSTEM (P830026/S035)Boston Scientific1988-10-24
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