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Cardiovascular

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

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RecordFirmDate
SYNCHRONY(R) CARDIAC PACING SYSTEM (P880086/S030)ABBOTT MEDICAL1995-01-23
CORONARY BALLOON DILITATION CATHETERS PTCA (P840040/S042)Boston Scientific Corp1995-01-23
MODEL 531-45 GRAPHICS PROGRAM MODULE (P830026/S063)Boston Scientific1995-01-23
INTERTACH(R)II MODELS 262-16 (P860007/S011)Boston Scientific1995-01-18
RELAY-DASH PACING SYSTEM (P910020/S006)Boston Scientific1995-01-18
RELAY-DASH PACING SYSTEM (P910020/S007)Boston Scientific1995-01-17
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S007)ABBOTT MEDICAL1995-01-17
SENSOLOG (R) ULTILOG (TM) MODELS 2040K,2040T (P880006/S017)St. Jude Medical, Inc.1995-01-12
MEDTRONIC(R) MODEL 9870A SOFTWARE DISKETTES (P890003/S028)Medtronic, Inc.1995-01-11
MEDTRONIC(R) THERA(TM) PULSE GENERATORS (P890003/S031)Medtronic, Inc.1995-01-10
MEDTRONIC SINGLE CHAMBER PACEMAKERS (P850051/S049)Medtronic, Inc.1995-01-05
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S034)Cordis Corp.1995-01-05
MEDTRONIC(R) THERA(TM) PULSE GENERATORS (P890003/S033)Medtronic, Inc.1995-01-05
MEDTRONIC SINGLE CHAMBER PACEMAKERS (P850051/S048)Medtronic, Inc.1995-01-05
SCIMED(R) PTCA CATHETER (P860019/S096)Scimed Life Systems, Inc.1995-01-05
MEDTRONIC SINGLE CHAMBER PACEMAKERS (P850051/S046)Medtronic, Inc.1995-01-05
IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S001)Intensive Technology, Inc.1995-01-05
AFP CARDIAC PACING SYSTEM (P830045/S049)St. Jude Medical, Inc.1995-01-05
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S019)Cordis Corp.1994-12-13
AFP CARDIAC PACING SYSTEM (P830045/S048)St. Jude Medical, Inc.1994-12-13
HYBRID (PTCA) CATHETER (P850021/S027)Abbott Vascular, Inc.1994-12-13
CAPSURE(R) AND CAPSURE(R)SP LEADS (P850089/S031)Medtronic Cardiac Rhythm Disease Management1994-12-13
SCIMED(R) DYNA-MITE(T)PTCA CATHETER (P860019/S088)Scimed Life Systems, Inc.1994-12-13
MEDTRONIC(R) CAPSURE(R) SP TRANSVENOUS PACING LEAD (P830061/S024)Medtronic Cardiac Rhythm Disease Management1994-12-12
CAPSURE(R) AND CAPSURE(R)SP LEADS (P850089/S029)Medtronic Cardiac Rhythm Disease Management1994-12-08
DELTA(R) PULSE GENERATOR (P840068/S020)Boston Scientific1994-12-08
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S025)Abbott Vascular1994-12-02
CCS MODEL 325 PACEMAKER SYSTEM (P890039/S012)Cardiac Control Systems, Inc.1994-12-02
MEDTRONIC(R) SYNERGYST II (P890003/S027)Medtronic, Inc.1994-11-29
VENTAK(R) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIB (P830060/S035)Boston Scientific1994-11-23
ENDOTAK(R) LEAD SYSTEM (P910073/S004)Boston Scientific1994-11-23
VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR (P910077/S001)Boston Scientific1994-11-23
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S009)Abiomed Cardiovascular, Inc.1994-11-17
SCIMED(R) NC COBRA 18 PTCA CATHETER (P860019/S084)Scimed Life Systems, Inc.1994-11-15
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S007)Spectranetics Corp.1994-11-15
ACS RX FLOWTRACK LONG(TM) CORONARY DILATATION CATH (P810046/S152)Advanced Cardiovascular Systems, Inc.1994-11-14
MEDTRONIC(R) 14K(TM)CORONARY BALL DILATATION CATH (P870036/S025)Medtronics Interventional Vascular1994-11-09
MIGHTY(TM) CORONARY BALLOON DILATATION CATHETERS (P840040/S041)Boston Scientific Corp1994-11-07
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S006)Spectranetics Corp.1994-10-31
SYNCHRONY(R) CARDIAC PACING SYSTEM (P880086/S026)ABBOTT MEDICAL1994-10-31
EPT-1000 CARDIAC ABLATION SYSTEM (P920047)Boston Scientific Corp1994-10-28
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S003)ABBOTT MEDICAL1994-10-28
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S006)ABBOTT MEDICAL1994-10-28
BIOPOLYMERIC(TM) VASCULAR GRAFT (P800058/S015)St. Jude Medical, Inc.1994-10-25
CORDIS BASIC 18 PTCA DILATATION CATHETER (P880003/S031)Cordis Corp.1994-10-25
VIGOR DDD PACEMAKER SYSTEM (P840068/S021)Boston Scientific1994-10-21
ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II (P920027)C.R. Bard, Inc.1994-10-21
SCIMED(R) PTCA CATHETER (P860019/S093)Scimed Life Systems, Inc.1994-10-17
CARBON TIP CARDIAC PACING LEAD (P800041/S014)Pacesetter Systems1994-10-17
SYNCHRONY MODELS PARAGON III/PHOENIX III PACERS (P880086/S022)ABBOTT MEDICAL1994-10-17
SCIMED(R) TRIO(TM) 14 PTCA CATHETER (P860019/S083)Scimed Life Systems, Inc.1994-10-14
3.4F SYNERGY(TM) II LONG BALL. DILATATION CATHETER (P840040/S043)Boston Scientific Corp1994-10-06
MEDTRONIC SINGLE CHAMBER PACEMAKERS (P850051/S043)Medtronic, Inc.1994-10-06
MEDTRONIC DUAL CHAMBER PACEMAKERS (P890003/S029)Medtronic, Inc.1994-10-06
ORACLE(TM) CORONARY BALLOON DILATATION CATHETER (P910031)Abbott Vascular Devices1994-09-30
CORDIS EUROPASS PTCA DILATATION CATHETER (P880003/S023)Cordis Corp.1994-09-30
HEARTMATE VE LVAS (P920014)Thoratec Corp1994-09-30
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S011)Abiomed Cardiovascular, Inc.1994-09-30
2.9F-TO-3.4F ALLY(TM) PTCA CATHETER (P840040/S045)Boston Scientific Corp1994-09-30
CORDIS PREDATOR PTCA DILATATION CATHETER (P880003/S030)Cordis Corp.1994-09-29
CORDIS SLEEK DILATATION CATHETERS (P880003/S029)Cordis Corp.1994-09-29
PERCUTANEUS TRANSLUMINAL CORONARY ANGIOPLASTY CATH (P940009)Scimed Life Systems, Inc.1994-09-29
CORDIS WORLDPASS PTCA DILITATION CATHETER (P880003/S028)Cordis Corp.1994-09-29
OG(R) CARDIAC PACING SYSTEM (P880006/S020)St. Jude Medical, Inc.1994-09-27
MIGHTY(TM) PTCA BALLOON DILITATION CATHETER (P840040/S046)Boston Scientific Corp1994-09-27
SYNCHRONY(R) CARDIAC PACING SYSTEM (P880086/S027)ABBOTT MEDICAL1994-09-27
AFP CARDIAC PACING SYSTEM (P830045/S046)St. Jude Medical, Inc.1994-09-27
SCIMED(R) PTCA CATHETER (P860019/S091)Scimed Life Systems, Inc.1994-09-27
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S010)Abiomed Cardiovascular, Inc.1994-09-23
SCIMED(R) INDY(TM) PTCA CATHETER (P860019/S087)Scimed Life Systems, Inc.1994-09-22
GEMNOS TC 04 PULSE GENERATOR & SOFTWARE MODULE (P820076/S016)Biotronik, Inc.1994-09-19
SCIMED(R) PTCA CATHETER (P860019/S085)Scimed Life Systems, Inc.1994-09-13
ENDOTAK(R) CLEAD SYSTEM (P910073/S002)Boston Scientific1994-09-13
SCIMED(R) PTCA CATHETER (P860019/S090)Scimed Life Systems, Inc.1994-09-12
MEDTRONIC DUAL CHAMBER PACEMAKERS (P890003/S030)Medtronic, Inc.1994-09-06
MEDTRONIC SINGLE CHAMBER PACEMAKERS (P850051/S044)Medtronic, Inc.1994-09-06
SYNCHRONY(R) CARDIAC PACING SYSTEM (P880086/S025)ABBOTT MEDICAL1994-08-30
MEDTRONIC(R) EVERGREEN(TM) COR.BALL.DIL. CATH. (P870036/S030)Medtronics Interventional Vascular1994-08-30
REFLEX MODEL 8223E (P820018/S064)St. Jude Medical, Inc.1994-08-30
MEDTRONIC(R) PANTHER (TM) 40 COR..BALL. DIL. CATH. (P870036/S029)Medtronics Interventional Vascular1994-08-30
SCIMED(R) NC COBRA(TM) 14 PTCA CATHETER (P860019/S089)Scimed Life Systems, Inc.1994-08-29
SCIMED(R) PTCA CATHETER (P860019/S086)Scimed Life Systems, Inc.1994-08-25
HYBRID (PTCA) CATHETER (P850021/S028)Abbott Vascular, Inc.1994-08-19
QRAKSTAR 14 PTCA CATHETERS (P880003/S026)Cordis Corp.1994-08-18
MEDTRONIC MODEL 9751C SYS. ENHANCEMENT MODULE (P820003/S068)Medtronic Cardiac Rhythm Disease Management1994-08-15
TRAKSTAR 18 PTCA CATHETERS (P880003/S027)Cordis Corp.1994-08-12
COOK BIRD'S NEST VENA CAVA FILTER (P850049/S004)Cook, Inc.1994-08-09
VENTAK MODELS 1550 AND 1555 (P830060/S034)Boston Scientific1994-08-08
VENTAK(R) P MODEL 1600 (P890061/S008)Boston Scientific1994-08-08
ENDOTAK(R) C LEAD, MODELS 0070, 0072,0074 (P910073/S001)Boston Scientific1994-08-05
ACS RX ELIPSE(TM) .014 CORNARY DILITATION CATH. (P810046/S149)Advanced Cardiovascular Systems, Inc.1994-08-04
LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT (P890001/S010)Leocor, Inc.1994-08-04
PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT (P900043)Cordis Corp.1994-08-02
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S001)ABBOTT MEDICAL1994-07-29
AORTIC VALVED GRAFT WITH MEADOX(R) HEMASHIELD(R) (P810002/S032)ABBOTT MEDICAL1994-07-29
LEOCOR PICO RUNNER CATHETER (P890001/S009)Leocor, Inc.1994-07-28
SYNERGY(TM) CONVERTIBLE RAPID EXCHANGE PTCA CATH (P840040/S044)Boston Scientific Corp1994-07-26
ALTERNATE STERILIZATION /VISTA(TM)T PRODUCTS (P840068/S017)Boston Scientific1994-07-26
MEDTRONIC(R)SPIRIT(TM)30 & 40 COR.BALL. DIL. CATH. (P870036/S028)Medtronics Interventional Vascular1994-07-26
HYBRID (PTCA) CATHETER (P850021/S026)Abbott Vascular, Inc.1994-07-26
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