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Cardiovascular

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

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RecordFirmDate
GEMNOS (TM) CARDIAC PACEMAKER (4.34) (P820076/S011)Biotronik, Inc.1991-12-20
AUTIMA MODEL 2251 GENERATOR & MODEL 2600 PROGRAMME (P820018/S053)St. Jude Medical, Inc.1991-12-20
CAPSURE(R) PACING LEADS (P850089/S016)Medtronic Cardiac Rhythm Disease Management1991-12-20
MODELS 7070,7071,7071M,SYNERGEST(TM)II PULSE GEN (P890003/S010)Medtronic, Inc.1991-12-18
MODELS 8416,17,18,19 LEGEND PACEMAKERS (P850051/S034)Medtronic, Inc.1991-12-18
MODEL 6866 AICD SPLICE TOOL KIT,6862,63,65,34 (P830060/S027)Boston Scientific1991-12-18
MEDTRONIC(R) 7000 VERSATRAX(R) PULSE GENERATOR (P820003/S060)Medtronic Cardiac Rhythm Disease Management1991-12-18
META MV MODEL 1202 CARDIAC PACING SYSTEM (P880038/S018)St. Jude Medical, Inc.1991-12-09
MODEL 925 DELTA PULSE GENERATOR (P840068/S016)Boston Scientific1991-12-09
AURORA MODEL 6291,2,6 & META DDD MODEL 1230 (P820018/S054)St. Jude Medical, Inc.1991-12-06
USCI(R) FORCE(R) BALL. DIL. CATH. W/PRO/PEL COAT. (P790017/S039)Medtronic, Ireland1991-12-06
USCI(R) SPRINT(TM) BALL. DIL. CATH. W/PRO/PEL COAT (P790017/S040)Medtronic, Ireland1991-12-06
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S012)Cordis Corp.1991-12-03
PHANTOM(TM) CATHETER (P860019/S046)Scimed Life Systems, Inc.1991-11-27
NOVA II MODEL 282-04Y PULSE GENERATOR (P830026/S047)Boston Scientific1991-11-26
MODEL 6577 STERILIZABLE TELEMETRY WAND (P890061/S002)Boston Scientific1991-11-26
LEGEND II MODELS 8424,8426,8427 AND 8430 PULSE G. (P850051/S032)Medtronic, Inc.1991-11-25
MODEL 9855 SOFTWARE SYSTEM (P890003/S009)Medtronic, Inc.1991-11-25
CORONARY DILATION CATHETERS (P810046/S107)Advanced Cardiovascular Systems, Inc.1991-11-20
MODEL 6577 STERILIZABLE TELEMETRY WAND (P840068/S015)Boston Scientific1991-11-20
COSMOS II IMPLANTABLE PACEMAKER PULSE GENERATOR (P830026/S049)Boston Scientific1991-11-20
MODEL 5603 PROGRAMMER (P820018/S055)St. Jude Medical, Inc.1991-11-20
MODEL 6577 STERILIZABLE TELEMETRY WAND (P830060/S026)Boston Scientific1991-11-20
INTERTACH & INTERTACH II PULSE GENERATORS (P860007/S006)Boston Scientific1991-11-19
SCIMED TRAPPER(TM) EXCHANGE DEVICE (P860019/S040)Scimed Life Systems, Inc.1991-11-19
SCIMED ACE(TM) & EXPRESS(TM) PTCA CATHETERS (P860019/S044)Scimed Life Systems, Inc.1991-11-19
9600 NETWORK PROGRAMMER & X92 PULSE GEN. MODELS (P820018/S047)St. Jude Medical, Inc.1991-11-13
SJM AORTIC VALVED GRAFT (AVG) PROSTHESIS (P810002/S021)ABBOTT MEDICAL1991-11-06
MODEL 3037A FUNCTION PACK (P830045/S035)St. Jude Medical, Inc.1991-10-28
LEOCOR PICOCATH(TM) MODEL PICO-ST (P890001/S006)Leocor, Inc.1991-10-25
AUTIMA MODEL 2251 GENERATOR & MODEL 2600 PROGRAMME (P820018/S052)St. Jude Medical, Inc.1991-10-25
MODELS 8416 AND 8418 LEGEND PACEMAKERS (P850051/S033)Medtronic, Inc.1991-10-25
REFLEX MODEL 8223E DUAL CHAMBER PULSE GENERATOR (P820018/S051)St. Jude Medical, Inc.1991-10-25
INTERTACH & INTERTACH II PULSE GENERATORS (P860007/S007)Boston Scientific1991-10-16
META II MODEL 1204 CARDIAC PACING SYSTEM (P880038/S013)St. Jude Medical, Inc.1991-10-11
HELIX PTCA DILATATION CATHETER (P880003/S006)Cordis Corp.1991-10-04
MEDTRONIC(R) 18K(TM) OVER THE WIRE BALL. CATHETER (P870036/S012)Medtronics Interventional Vascular1991-10-04
MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM (P890039/S005)Cardiac Control Systems, Inc.1991-10-04
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S011)Cordis Corp.1991-10-04
MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM (P890039/S004)Cardiac Control Systems, Inc.1991-10-04
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S018)ABBOTT MEDICAL1991-09-30
STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES (P870038)Edwards Lifesciences, LLC1991-09-27
PALMAZ BALLOON EXPANDABLE STENT (P890017)Cordis US Corporation1991-09-27
9751B SYSTEM ENHANCEMENT MODULE PRINTER (P820003/S059)Medtronic Cardiac Rhythm Disease Management1991-09-27
EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057)Edwards Lifesciences, LLC1991-09-26
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077)Edwards Lifesciences, LLC1991-09-25
CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625 (P870056)Edwards Lifesciences, LLC1991-09-25
N.C.G.T. GRAFT (P800058/S011)St. Jude Medical, Inc.1991-09-19
SENSOLOG 2020T, SESOLOG II 2022T, SOLUS 200T (P880086/S014)ABBOTT MEDICAL1991-09-16
APS-11 MODEL 3003 PROGRAMMER (P880086/S011)ABBOTT MEDICAL1991-09-16
APS-II MODEL 3003 PROGRAMMER (P880006/S010)St. Jude Medical, Inc.1991-09-16
APS-II MODEL 3003 PROGRAMMER (P830045/S033)St. Jude Medical, Inc.1991-09-16
AMERICAN EDWARDS LABS HYBRID PTCA CATHETER (P850021/S014)Abbott Vascular, Inc.1991-09-16
PACESETTER MODEL 3070 & PACE MEDICAL MODEL 4553 (P830045/S031)St. Jude Medical, Inc.1991-09-11
CHORUS DDD PACEMAKER (P900022)MicroPort CRM USA, Inc.1991-09-06
ACS RX ALPHA CORONARY DILATION CATHETERS (P810046/S109)Advanced Cardiovascular Systems, Inc.1991-09-04
SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B (P880006/S008)St. Jude Medical, Inc.1991-09-03
ACE(TM) AND LONG ACE(TM) MODELS (P860019/S043)Scimed Life Systems, Inc.1991-08-29
BIOPOLYMERIC(TM) VASCULAR GRAFT (P800058/S014)St. Jude Medical, Inc.1991-08-29
MODEL AT-103(SIZES 19-31MM) & MT-103(SIZES 19-33MM (P810002/S020)ABBOTT MEDICAL1991-08-29
SCIMED(R) PTCA CATHETER (P860019/S041)Scimed Life Systems, Inc.1991-08-27
SIMPSON CORONARY ATHEROCATH(TM) SCA-LP(TM) DEVICE (P890043/S011)Abbott Vascular1991-08-27
MODEL 5603 PROGRAMMER SOFTWARE, VP.11P. (P820018/S049)St. Jude Medical, Inc.1991-08-21
MODEL 1210 OMNIPULSE(TM) HOLMIUM LASER SYSTEM (P870043/S013)Trimedyne, Inc.1991-08-20
SOLUS 2002,2003 & SYNCHRONY II 2022,2023 PULSE GEN (P880086/S013)ABBOTT MEDICAL1991-08-19
CAPSURE(R)SP MODELS 4024/4524 PACING LEADS (P830061/S012)Medtronic Cardiac Rhythm Disease Management1991-08-19
MODEL 9852 SOFTWARE SYSTEM (P890003/S008)Medtronic, Inc.1991-08-19
ACS RX(R) ALPHA .O14 CORONARY DILITATION CATHETER (P810046/S105)Advanced Cardiovascular Systems, Inc.1991-08-15
VENTAK(TM) ECD (P830060/S025)Boston Scientific1991-08-12
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S010)Medtronic Cardiac Rhythm Disease Management1991-08-07
MODEL 283 PULSE GENERATOR & MODEL 370 PROGRAMMER (P830045/S030)St. Jude Medical, Inc.1991-08-07
ACS RX ALPHA CORONARY DILATION CATHETERS (P810046/S108)Advanced Cardiovascular Systems, Inc.1991-08-06
LASTAC SYSTEM (P870071/S008)G V Medical, Inc.1991-08-06
HELIX PTCA DILATATION CATHETER (P880003/S005)Cordis Corp.1991-08-06
SCHNEIDER XLP(TM) PTCA CATHETER (P880027/S014)Boston Scientific1991-08-06
AUTIMA PACING SYSTEM (P820018/S050)St. Jude Medical, Inc.1991-07-31
NOVA II MODEL 282-04Y PULSE GENERATOR (P830026/S048)Boston Scientific1991-07-31
SYNERGYST(TM) II MODELS 7070/7071 (M) (A) (P890003/S006)Medtronic, Inc.1991-07-26
ACTIVITRAX,ATRIVITRAX II, LEGEND, & MICRO MINIX (P850051/S030)Medtronic, Inc.1991-07-26
GEMNOS (TM) CARDIAC PACEMAKER (P820076/S010)Biotronik, Inc.1991-07-26
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S009)Cordis Corp.1991-07-25
SELF-VENT TO ACS CORONARY DILATATION CATHETER (P810046/S100)Advanced Cardiovascular Systems, Inc.1991-07-25
MICROSS-SL(TM) PTCA DILATATION CATHETER (P880055/S003)Boston Scientific Corp1991-07-19
HEART TRAK PTCA CATHETER (P840040/S025)Boston Scientific Corp1991-07-12
HEART TRAK PTCA CATHETER (P840040/S024)Boston Scientific Corp1991-07-12
INTERTACH(R) II IMPLANT. PACEMAKER PULSE GENERATOR (P860007/S005)Boston Scientific1991-07-02
ACS RX ALPHA(TM).010 CORONARY DILITATION CATHETER (P810046/S098)Advanced Cardiovascular Systems, Inc.1991-06-27
SOLUS(TM) MODEL 2002L & SYNCHRONY II MODEL 2022L (P880086/S009)ABBOTT MEDICAL1991-06-26
LASTAC SYSTEM (P870071/S006)G V Medical, Inc.1991-06-25
ACS SPECTRUM(TM) CORONARY DILATATION CATHETER (P810046/S103)Advanced Cardiovascular Systems, Inc.1991-06-25
PMS-600 PROGRAMMER (P820076/S012)Biotronik, Inc.1991-06-17
SELF-VENT TO ACS CORONARY DILATATION CATHETER (P810046/S099)Advanced Cardiovascular Systems, Inc.1991-06-17
SCHNEIDER MONORAIL PICCOLINO(R) FORTE PTCA CATH. (P880027/S018)Boston Scientific1991-06-13
LEOCOR CORFLO(TM) MODEL 7.5PT PTCA CATHETER (P890001/S004)Leocor, Inc.1991-06-12
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S004)Abbott Vascular1991-06-12
HEART TRAK PTCA CATHETER (P840040/S026)Boston Scientific Corp1991-05-30
ACS RX ALPHA(TM) .018 CORONARY DILATATION CATHETER (P810046/S096)Advanced Cardiovascular Systems, Inc.1991-05-30
SCHNEIDER MONORAIL PICCOLINO(R) PTCA CATHETER (P880027/S016)Boston Scientific1991-05-21
SCHNEIDER MONORAIL PICCOLINO(R) PTCA CATHETER (P880027/S015)Boston Scientific1991-05-21
VENTAK 1550 PULSE GENERATOR (P830060/S014)Boston Scientific1991-05-17
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