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Cardiovascular

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

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RecordFirmDate
MODEL 446 & 447 VISTA T PU.GEN. MODEL 2046 SOF.MOD (P840068/S012)Boston Scientific1991-05-17
NOVA II MODEL 282-04Y PULSE GENERATOR (P830026/S046)Boston Scientific1991-05-16
MODEL 6837 & 6839 INDUCTION/MONITOR & 6871 O-RINGS (P830060/S024)Boston Scientific1991-05-16
NOVA II MODEL 282-04R PULSE GENERATOR (P830026/S045)Boston Scientific1991-05-16
SCHNEIDER MONORAIL PICCOLINO(R) PTCA CATHETER (P880027/S012)Boston Scientific1991-05-16
ARZCO OCTAPOLAR ESOPHAGEAL PACE & RECORD CATHETER (P860008/S010)Cardio Command1991-05-09
VERSATRAX(TM) CARDIAC PACING SYSTEM (P820003/S053)Medtronic Cardiac Rhythm Disease Management1991-05-08
ACTIVITRAX PACING SYSTEM (P850051/S031)Medtronic, Inc.1991-05-08
VERSATRAX,SYMBIOS, & SYNERGYST MODELS (P820003/S058)Medtronic Cardiac Rhythm Disease Management1991-05-08
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S010)ABBOTT MEDICAL1991-05-02
VENTAK P 1600 AICD AND 2830 SOFTWARE MODULE (P890061)Boston Scientific1991-05-02
COOK BIRD'S NEST VENA CAVA FILTER (P850049/S002)Cook, Inc.1991-05-02
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S010)Cordis Corp.1991-04-26
MAESTRO(R) MODEL 1006P PACEMAKER PROGRAMMER (P890039/S002)Cardiac Control Systems, Inc.1991-04-25
MAESTRO(R) MODEL 1006P PACEMAKER PROGRAMMER (P860027/S008)Cardiac Control Systems, Inc.1991-04-25
ACS RX ALPHA .014 QUARTER SIZE BALLOON CATHETER (P810046/S101)Advanced Cardiovascular Systems, Inc.1991-04-25
MEDTRONIC ELITE(TM) MODELS 7074,7075,7076,& 7077 (P890003/S003)Medtronic, Inc.1991-04-24
THE INTREPID(TM) PTCA CATHETER (P850021/S013)Abbott Vascular, Inc.1991-04-22
USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM (P890048)Usci, Div. C.R. Bard, Inc.1991-04-17
SCIMED PTCA DILATATION CATHETER (P860019/S035)Scimed Life Systems, Inc.1991-04-05
SCHNEIDER MICROSOFTRAC/MONORAIL PICCOLINO (P880027/S011)Boston Scientific1991-04-03
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S009)Abbott Vascular1991-04-03
SCIMED PTCA DILATATION CATHETER-ACE ADVANTAGE(TM) (P860019/S039)Scimed Life Systems, Inc.1991-04-03
9751A SYSTEM ENHANCEMENT MODULE (SEM) (P820003/S056)Medtronic Cardiac Rhythm Disease Management1991-04-02
MICROSS-SL(TM) PTCA DILATATION CATHETER (P880055/S002)Boston Scientific Corp1991-03-28
META DDD MODEL 1230 PACER (P820018/S039)St. Jude Medical, Inc.1991-03-26
SCHNEIDER MONORAIL PICCOLINO(R) PTCA CATHETER (P880027/S013)Boston Scientific1991-03-26
CORDIS ORION EXTENSION (P890032/S008)Cordis Corp.1991-03-26
ESOPHAGEAL CARDIAC RECORDING & PACING CATHETER (P860008/S009)Cardio Command1991-03-25
CAPSURE(R)SP PACING LEADS (P830061/S015)Medtronic Cardiac Rhythm Disease Management1991-03-20
BUSHINDER OMNIFLEX OVER-THE-WIRE BALLOON CATHETER (P870036/S011)Medtronics Interventional Vascular1991-03-20
SCIMED PTCA DILATATION CATHETER (P860019/S031)Scimed Life Systems, Inc.1991-03-20
ACS PINKERTON .018(TM)CORONARY DILATATION CATHETER (P810046/S097)Advanced Cardiovascular Systems, Inc.1991-03-20
ACS(R) STACK PERFUSION(R) CORONARY DILATATION CATH (P810046/S095)Advanced Cardiovascular Systems, Inc.1991-03-20
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S006)Abbott Vascular1991-03-19
USCI GRUNTZIG DILACA CATHETER (P790017/S022)Medtronic, Ireland1991-03-14
AURORA MODELS 6291 AND 6292 PACEMAKERS (P820018/S048)St. Jude Medical, Inc.1991-03-14
HEART TRAK PTCA CATHETER (P840040/S023)Boston Scientific Corp1991-03-08
LEOCOR,INC. PICOCATH CATHETER 2,2.5,3,3.5, BALLOON (P890001/S003)Leocor, Inc.1991-03-08
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S025)Trimedyne, Inc.1991-02-25
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S008)Abbott Vascular1991-02-21
SYNCHRONY II MODEL 2023M/S & SOLAS MODEL 2003M/S (P880086/S007)ABBOTT MEDICAL1991-02-13
LASTAC SYSTEM (P870071/S007)G V Medical, Inc.1991-02-08
AID(R) B/BR (P830060/S022)Boston Scientific1991-02-08
LEGEND PULSE GENERATORS & MICRO MINIX (P850051/S028)Medtronic, Inc.1991-02-06
MODELS 5342 & 5345 TEMPORARY PULSE GENERATORS (P820003/S057)Medtronic Cardiac Rhythm Disease Management1991-02-06
HYBRID PTCA CATHETER (P850021/S012)Abbott Vascular, Inc.1991-02-04
PROACT TW PTCA CATHETER (P840040/S020)Boston Scientific Corp1991-01-31
MODEL 283 PULSE GENERATOR MODEL 370 PROGRAMMER (P830045/S028)St. Jude Medical, Inc.1991-01-31
SYNCHRONY II MODEL 2023M/S & SOLAS MODEL 2003M/S (P880086/S008)ABBOTT MEDICAL1991-01-31
BUSHINDER THRUFLEX OVER-THE-WIRE BALLOON CATHETER (P870036/S010)Medtronics Interventional Vascular1991-01-30
HEART TRAK PTCA CATHETER (P840040/S022)Boston Scientific Corp1991-01-30
MAESTRO SERIES 500 P.G.& MODEL 1006 PACEMAKER PROG (P860027/S007)Cardiac Control Systems, Inc.1991-01-30
SCIMED PTCA DILATATION CATHETER (P860019/S030)Scimed Life Systems, Inc.1991-01-25
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S007)Abbott Vascular1991-01-22
SCIMED PTCA DILATATION CATHETER-ACE ADVANTAGE(TM) (P860019/S038)Scimed Life Systems, Inc.1991-01-18
MICROSOFTRAC (R) PTCA CATHETER (P880027/S009)Boston Scientific1991-01-18
SCHNEIDER MAGNUM-MEIER(R) PTCA CATHETER (P880027/S010)Boston Scientific1991-01-18
ACS HP CORONARY DILATATION CATHETER (P810046/S094)Advanced Cardiovascular Systems, Inc.1991-01-17
ACS(R) DILATATION CATHETERS (P810046/S087)Advanced Cardiovascular Systems, Inc.1991-01-14
MAESTRO SERIES 500 P.G.& MODEL 1006 PACEMAKER PROG (P860027/S006)Cardiac Control Systems, Inc.1991-01-10
CPI SUTURELESS MYOCARDIAL LEAD MODEL 4320 (P830060/S021)Boston Scientific1991-01-07
LEGEND PULSE GENERATORS & MICRO MINIX (P850051/S029)Medtronic, Inc.1990-12-27
ACS SLALOM(TM) DILATATION CATHETRER (P810046/S091)Advanced Cardiovascular Systems, Inc.1990-12-27
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S005)Abbott Vascular1990-12-27
0CIMED PTCA DILATATION CATHETER (P860019/S027)Scimed Life Systems, Inc.1990-12-27
MEDTRONIC SYNERGYST II MODEL 7070 PULSE GENERATOR (P890003/S005)Medtronic, Inc.1990-12-27
SYMBIOS MODEL 7006 & SYNERGYST MODEL 7026 PULSE G. (P820003/S055)Medtronic Cardiac Rhythm Disease Management1990-12-27
VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM (P870036/S009)Medtronics Interventional Vascular1990-12-20
LEOCOR,INC. MODELS 7.5S (P890001/S001)Leocor, Inc.1990-12-20
PARAGON(TM) MODEL 2011M/S PULSE GENERATOR (P830045/S029)St. Jude Medical, Inc.1990-12-20
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S001)Abbott Vascular1990-12-19
SLIDER 018 CATHETER (P840040/S014)Boston Scientific Corp1990-12-19
MODEL 283 PULSE GENERATOR MODEL 370 PROGRAMMER (P830045/S027)St. Jude Medical, Inc.1990-12-19
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S002)Abbott Vascular1990-12-19
SCIMED PTCA DILATATION CATHETER (P860019/S033)Scimed Life Systems, Inc.1990-12-19
SCIMED PTCA DILATATION CATHETER (P860019/S034)Scimed Life Systems, Inc.1990-12-19
MEDTRONIC SYNERGYST II MODEL 7070 PULSE GENERATOR (P890003/S004)Medtronic, Inc.1990-12-18
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S003)Abbott Vascular1990-12-18
CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S010)Pacesetter Systems1990-12-18
SYMBIOS MODEL 7006 & SYNERGYST MODEL 7026 PULSE G. (P820003/S054)Medtronic Cardiac Rhythm Disease Management1990-12-18
VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM (P870036/S008)Medtronics Interventional Vascular1990-12-18
ACS(R) HARTZLER EXCEL CORONARY DILATATION CATHETER (P810046/S077)Advanced Cardiovascular Systems, Inc.1990-12-18
SYNCHRONY MODEL 2020T CARDIAC PACING SYSTEM (P880086/S006)ABBOTT MEDICAL1990-12-18
PTCA CATHETER WITH 3.5 MM BALLOON (P850021/S011)Abbott Vascular, Inc.1990-12-18
SCIMED PTCA DILATATION CATHETER-ACE ADVANTAGE(TM) (P860019/S037)Scimed Life Systems, Inc.1990-12-13
META MV MODEL 1202 CARDIAC PACING SYSTEM (P880038/S017)St. Jude Medical, Inc.1990-12-13
ACTRIVITRAX & II MODEL 8400 & 8412 & LEGEND 8416 (P850051/S027)Medtronic, Inc.1990-12-12
ACS CORONARY DILATATION CATHETERS (P810046/S072)Advanced Cardiovascular Systems, Inc.1990-12-12
CAPSURE(R)SP PACING LEADS (P830061/S014)Medtronic Cardiac Rhythm Disease Management1990-12-10
CAPSURE(R) PACING LEADS (P850089/S015)Medtronic Cardiac Rhythm Disease Management1990-12-10
\EART TRAK,HART TRAK III,MAX TRAK,MAX TRAK DP,PROA (P840040/S021)Boston Scientific Corp1990-12-10
MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER (P880065/S001)Boston Scientific Corp1990-12-10
CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S009)Pacesetter Systems1990-12-10
ACS(R) TEN(TM) (.010) DILATATION CATHETER (P810046/S085)Advanced Cardiovascular Systems, Inc.1990-12-10
ACS SLALOM(TM) DILATATION CATHETER (P810046/S088)Advanced Cardiovascular Systems, Inc.1990-12-04
MODEL 9710A PROGRAMMER (P820003/S052)Medtronic Cardiac Rhythm Disease Management1990-12-04
SLIDER .014 AND COATED GLIDER PTCA CATHETERS (P840040/S018)Boston Scientific Corp1990-11-19
ACS(R) STACK 40-S(TM) CORONARY DILATATION CATHETER (P810046/S086)Advanced Cardiovascular Systems, Inc.1990-11-15
GLIDER PTCA CATHETER (P840040/S019)Boston Scientific Corp1990-11-14
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