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Cardiovascular

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

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RecordFirmDate
CORDIS WEBSTER DIAGNOSITIC/ABLATION DEFLECTABLE TIP CATHETER & CATHETER-THERMOCOUPLE OR THERMISTOR (P950005/S003)Biosense Webster, Inc.1999-01-26
ACS MULTI-LINK RX AND OTW DUET CORONARY STENT SYSTEM (P970020/S008)Abbott Vascular, Inc.1999-01-25
AFFINITY SR MODELS 5130 (LS,RS,L,R)PULSE GENERATORS AFFINITY DR MODELS 5330 (LS, RS,L,R)PULSE GENERATORS (P880086/S050)ABBOTT MEDICAL1999-01-22
ACS RX COMET VP CORONARY DILATATION CATHETER (OTHER DILATATION CATHETERS) (P810046/S196)Advanced Cardiovascular Systems, Inc.1999-01-22
AFFINITY DR & AFFINITY SR PULSE GENERATORS (P880086/S051)ABBOTT MEDICAL1999-01-21
APS III PROGRAMMER WITH MODEL 3303 SOFTWARE (P830045/S059)St. Jude Medical, Inc.1999-01-21
MODEL 6960 SWITCHABLE ECG PATIENT CABLE (P910077/S026)Boston Scientific1999-01-20
VENTAK AV AICD & VENTAK AV II DDD AICD (P960040/S010)Boston Scientific1999-01-20
ACS MULTI-LINK RX DUET CORONARY STENT SYSTEM AND THE ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEM (P970020/S007)Abbott Vascular, Inc.1999-01-12
SCIMED COYOTE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S151)Scimed Life Systems, Inc.1999-01-11
OVER THE WIRE DILATATION CATHETERS (P790017/S068)Medtronic, Ireland1999-01-08
MODEL 7271 ICD (P980016/S001)Medtronic Cardiac Rhythm Disease Management1999-01-06
ACTROS+ (P950037/S006)Biotronik, Inc.1999-01-05
IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S004)Intensive Technology, Inc.1998-12-30
OMNISCIENCE CARDIAC VALVE PROSTHESIS (P830039/S009)Medical Cv, Inc.1998-12-30
MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM;GFX OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S012)Medtronic, Ireland1998-12-29
PYROGEN TESTING OF ACS/CORNARY DILATATION CATHETERS E-BEAM- RADIATION STERILIZER (P810046/S187)Advanced Cardiovascular Systems, Inc.1998-12-28
CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER (P950029/S001)MicroPort CRM USA, Inc.1998-12-22
ACS RX GEMINI CORONARY DILATATION CATHETER (P810046/S193)Advanced Cardiovascular Systems, Inc.1998-12-22
TECHSTAR AND TECHSTAR XL 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL SYSTEMS (P960043/S010)Abbott Vascular, Inc.1998-12-21
PROSTAR XL AND TECHSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMS (P960043/S014)Abbott Vascular, Inc.1998-12-21
GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER (P850049/S006)Cook, Inc.1998-12-21
VASOSEAL ES DEVICE (P920004/S008)St. Jude Medical, Inc.1998-12-11
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S015)Terumo Medical Corporation1998-12-11
THE ORACLE MEGASONICS FIVE-64 PTCA CATHER (P910031/S019)Abbott Vascular Devices1998-12-11
NINJA PTCA DILATION CATHETERS (P880003/S075)Cordis Corp.1998-12-11
TVL LEAD SYSTEM (P950022/S004)ABBOTT MEDICAL1998-12-09
CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S037)ABBOTT MEDICAL1998-12-09
VENTAK AV II/III DR AICD SYSTEMS (P960040/S008)Boston Scientific1998-12-08
SWEET TIP (P830060/S044)Boston Scientific1998-12-08
VENTAK AV AICD FAMILY SYSTEMS (P960040/S007)Boston Scientific1998-12-08
TECHSTAR AND PROSTAR PERCUTANEOUS VASCULAR SURGICAL SYSTEMS (P960043/S013)Abbott Vascular, Inc.1998-12-07
VENTAK MINI ACID FAMILY SYSTEMS (P910077/S025)Boston Scientific1998-12-02
WALLSTENT TIPS ENDOPROSTHESIS (P930031/S005)Boston Scientific Corp1998-11-30
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S014)Terumo Medical Corporation1998-11-25
ACS RX MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM (P970020/S003)Abbott Vascular, Inc.1998-11-24
MEDTRONIC SPRINT MODELS 6943/6945 (P920015/S015)Medtronic, Inc.1998-11-23
MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS (P970012/S002)Medtronic, Inc.1998-11-19
KAIROS (P950037/S005)Biotronik, Inc.1998-11-19
CHORUS PACEMAKERS (P900022/S005)MicroPort CRM USA, Inc.1998-11-18
OPUS RM 4534 AND CHORUS RM 7034 PACEMAKERS (P950029/S003)MicroPort CRM USA, Inc.1998-11-18
SWEET TIP RX MODELS 4143/4144/4145/4243/4244/4245 ACTIVE-FIXATION, STEROID ELUTING, ENDOCARDIAL PACING LEADS (P960006/S002)Boston Scientific1998-11-17
MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S009)Medtronic, Ireland1998-11-17
GFX OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S010)Medtronic, Ireland1998-11-17
THE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER (P870036/S044)Medtronics Interventional Vascular1998-11-17
CHARGER PTCA DILATION CATHETERS (P880003/S077)Cordis Corp.1998-11-16
MEDTRONIC HALL PROSTHETIC HEART VALVE (P790018/S034)Medtronic Cardiac Surgery1998-11-16
ACS MULTI-LINK CORONARY STENT SYSTEMS (P970020/S006)Abbott Vascular, Inc.1998-11-10
POLY-SAFE(TM) A-TRACK(TM) PACING LEADS (P890039/S016)Cardiac Control Systems, Inc.1998-11-09
ACS MULTI-LINK RX DUET TM AND ACS MULTI-LINK OTW DUET TM CORONARY STENT SYSTEMS (P970020/S004)Abbott Vascular, Inc.1998-11-05
BIPOLAR ENDOCARDIAL LEAD (P830060/S043)Boston Scientific1998-11-04
DROMOS S.L. PACING SYSTEM (P820076/S021)Biotronik, Inc.1998-11-04
CADENCE (R) TIERED THERAPY DEFIBRILLAATOR SYSTEM (P910023/S036)ABBOTT MEDICAL1998-11-04
TRILOGY FAMILY OF PULSE GENERATORS (P880086/S056)ABBOTT MEDICAL1998-11-03
HANCOCK MODIFIED ORIFICE PORCINE BIOPROSTHETIC HEART VALVE (P790007/S015)Medtronic Heart Valves1998-10-30
MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS (P970031/S007)Medtronic, Inc.1998-10-30
TEMPO FAMILY OF PULSE GENERATORS (P900070/S024)St. Jude Medical, Cardiac Rhythm Management Divisi1998-10-29
CAPSURE SP NOVUS (P850089/S040)Medtronic Cardiac Rhythm Disease Management1998-10-29
PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980023)Biotronik, Inc.1998-10-27
CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S010)Edwards Lifesciences, LLC1998-10-26
MODEL 6998 IS-1 LEAD PORT PLUG (P910077/S024)Boston Scientific1998-10-26
CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS MODELS 6625LP AND 6625 LP-ESR (P870077/S008)Edwards Lifesciences, LLC1998-10-26
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE MODELS 2700 AND 2800 (P860057/S009)Edwards Lifesciences, LLC1998-10-26
SPL TRIPOLAR, TINED TRANSVENOUS DEFIBRILLATION LEADS (P950022/S003)ABBOTT MEDICAL1998-10-22
CONTOUR(R) II/ANGSTROM(TM) II ICD SYSTEMS (P910023/S034)ABBOTT MEDICAL1998-10-22
APS III PROGRAMMER WITH SOFTWARE MODEL 3302 REV.D (V1.04) (P880086/S053)ABBOTT MEDICAL1998-10-21
APS III PROGRAMMER WITH SOFTWARE MODEL 3302 REV.D (V1.04) (P830045/S061)St. Jude Medical, Inc.1998-10-21
CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S033)ABBOTT MEDICAL1998-10-21
ACS RX SOLARIS CORONARY DILATATION CATHETER (P810046/S192)Advanced Cardiovascular Systems, Inc.1998-10-16
TENDRIL DX ENDOCARDIAL PACING LEADS (P960013/S004)ABBOTT MEDICAL1998-10-15
TEMPO AND META PULSE GENERATORS (P900070/S023)St. Jude Medical, Cardiac Rhythm Management Divisi1998-10-15
SYNCHRONY, SOLUS, PHOENIX, PARAGON AND TRILOGY FAMILY OF PULSE GENERATORS (P880086/S052)ABBOTT MEDICAL1998-10-15
PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS (P960030/S003)ABBOTT MEDICAL1998-10-15
PARAGON II AND PHOENIX PULSE GENERATORS (P830045/S060)St. Jude Medical, Inc.1998-10-15
MEDTRONIC VISION SOFTWARE MODEL 9952-SERIES 2.1 AND MEDTRONIC. VISION SOFTWARE MODEL 9952A-SERIES 2.1 (P970012/S006)Medtronic, Inc.1998-10-15
REGENCY SC, SC+, AND SCX FAMILY OF PULSE GENERATORS (P880006/S028)St. Jude Medical, Inc.1998-10-15
VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016)Medtronic Cardiac Rhythm Disease Management1998-10-09
CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER (P950029/S002)MicroPort CRM USA, Inc.1998-10-09
MEDTRONIC CAPSURE SP MODEL 4523M (P830061/S029)Medtronic Cardiac Rhythm Disease Management1998-10-09
PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS (P960030/S004)ABBOTT MEDICAL1998-10-08
THE HEART LASER CO2 TMR SYSTEM (P950015/S001)Laser Engineering Heart, Inc.1998-10-06
MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C23520 (P960014)Global Therapeutics, Inc.1998-10-05
MEDTRONIC(R) MODEL 7227CX GEM (TM) IMPLANTABLE CARDIOVERTER (P900061/S035)Medtronic Cardiac Rhythm Disease Management1998-10-05
MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS (P940031/S016)Boston Scientific1998-10-02
SWEET TIP(R) RX STEROID ELUTING LEAD (P960006)Boston Scientific1998-10-02
SCIMED MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S144)Scimed Life Systems, Inc.1998-10-01
TORONTO SPV VALVE (P970030/S001)St. Jude Medical, Inc.1998-09-30
SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S141)Scimed Life Systems, Inc.1998-09-30
MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS (P970035/S005)Medtronic, Ireland1998-09-30
MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS (P970035/S007)Medtronic, Ireland1998-09-30
NOVACOR LVAS (P980012)Worldheart, Inc.1998-09-29
MAGIC WALLSTENT ENDOPROTHESIS (P980009)Boston Scientific Scimed, Inc.1998-09-29
HEARTMATE(R) VE LVAS (P920014/S007)Thoratec Corp1998-09-29
SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061/S004)Boston Scientific Scimed, Inc.1998-09-25
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S017)Terumo Medical Corporation1998-09-25
PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20 (P980017)Possis Medical, Inc.1998-09-25
OMNISCIENCE AND OMNICARBON CARDIAC VALVES (P830039/S008)Medical Cv, Inc.1998-09-25
CORDIS PALMAZ(R) BALLOON-EXPANDABLE STENT (P890017/S005)Cordis US Corporation1998-09-25
MODEL 8090 ANALYZER MODEL 5436 ANALYZER PATIENT CABLE, 5104/5104ANALYZER ADAPTORS, AND 8190 ANALYZER SOFTWARE (P890003/S054)Medtronic, Inc.1998-09-24
ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM (P950037/S004)Biotronik, Inc.1998-09-24
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