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Cardiovascular

19,134 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE (K905824)Cardiac Control Systems, Inc.1991-05-16
CORDIS PEEL-AWAY INSERTION TOOL (K910688)Cordis Corp.1991-05-16
XEMEX TEMPORARY PACING CATHETER A (K904868)Zeon Medical Corp.1991-05-16
RMI VASCULAR TOURNIQUET KIT (K910221)Research Medical, Inc.1991-05-16
MODIFIED PYROGEN TESTING (K910935)Electromedics, Inc.1991-05-16
504US PULSE OXIMETER (K910770)Criticare Systems, Inc.1991-05-14
AP-860PA NIBP MODULE (K910629)Nihon Kohden America, Inc.1991-05-14
INTRAVASCULAR IMAGING SYSTEM/MODIFIED (K910281)Intertherapy, Inc.1991-05-13
MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION (K910754)Hewlett-Packard Co.1991-05-08
INFLATE-A-CUFF #7014 (K910903)Pa Medical Corp.1991-05-08
ROBICSEK PROBE/RETRACTOR (K910682)Bio-Vascular, Inc.1991-05-08
PROPAQ 102EL, 104EL AND 106EL (K910882)Protocol Systems, Inc.1991-05-08
CARDIOCAP DR-124 RECORDER (K910620)Datex Division Instrumentarium Corp.1991-05-07
A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER (K905114)Research Consultants, Inc.1991-05-07
PERMANENT PACING LEAD (K905300)Oscor Medical Corp.1991-05-07
OSCOR MEDICAL CORP. PERMANENT PACING PAD (K905182)Oscor Medical Corp.1991-05-07
MODEL 5311B A-V PACING SYSTEM ANALYZER (K910595)Medtronic Vascular1991-05-07
PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK (K910861)Daig Corp.1991-05-07
CARD GUARD-3000 ECG TELEPHONE ADAPTER (K910450)Medtech Industries, Inc.1991-05-07
TRIOS 02 (K905087)Biotronik, GmbH & Co.1991-05-07
BARD(R) ENDOCARDIAL BALLOON ARRAY (K911140)C.R. Bard, Inc.1991-05-07
DISPOSABLE PATIENT CABLE (K910645)Diag Corp.1991-05-07
MODEL 205 SHOCK-TRODE (K910661)Cardiotronics, Inc.1991-05-02
INTERSPEC APOGEE, MODIFICATION (K910049)Interspec, Inc.1991-04-29
MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A (K910490)Hewlett-Packard Co.1991-04-26
INTIMAX THROMBECTOMY CATHETER (K910372)Applied Vascular Devices, Inc.1991-04-26
ARRHYTHMIA 9215 (K900366)S & W Medico Teknik1991-04-26
SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM) (K910204)Baxter Healthcare Corp1991-04-24
NOVOSTE GUIDING CATHETER (K911527)Novoste Corp.1991-04-24
PRESSURE MONITORING EXTENSION LINE (K910378)Professional Medical Services1991-04-22
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST (K904832)Hewlett-Packard Co.1991-04-22
SURGICAL TROCAR (K911462)Applied Medical1991-04-22
RESTING EKG ELECTRODE SERIES (K910494)Medtronic Andover Medical, Inc.1991-04-22
MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION (K910291)Hewlett-Packard Co.1991-04-22
THE PERCEPTOR(TM) STAND ALONE TRANSDUCER (K910764)North American Instrument Corp.1991-04-22
INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD (K903948)Intermedics, Inc.1991-04-22
ULTRA-SELECT PTCA GUIDEWIRE (K910280)Microvena Corp.1991-04-19
MODEL 5857-3M LEAD END CAP KIT (K911048)Medtronic Vascular1991-04-18
URESIL VALVE CUTTER (K905528)Uresil Corp.1991-04-18
SCHNEIDER MAGNARAIL PROBING CATHETER (K910259)Schneider Intl., Ltd.1991-04-18
SYSTEM 7300 PULSE OXIMETER (K910521)Advanced Medical Instruments, Inc.1991-04-18
MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT (K910630)Medtronic Vascular1991-04-18
CVIS INSIGHT IMAGING CATHETER (K904618)Cardiovascular Imaging Systems, Inc.1991-04-12
PROPAQ 102, 104 AND 106 (K910772)Protocol Systems, Inc.1991-04-12
CARDIOLAB AMPLIFIER MODULE (CAM) (K910307)Prucka Engineering, Inc.1991-04-12
ADVANCE 418(TM) (K904984)Peripheral Systems Group1991-04-12
DEFIBRILLATOR LEAD ADAPTER (K905065)Spacelabs, Inc.1991-04-12
DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD (K910107)Baxter Healthcare Corp1991-04-10
OPTI-PLAST 5F PTA CATHETERS (K910996)Vas-Cath, Inc.1991-04-09
MODEL 5866-46 SLEEVE KIT (K910568)Medtronic Vascular1991-04-09
BCD ADVANCED (K910923)Shiley, Inc.1991-04-09
MEDI-TECH BALLOON DILATATION CATHETER (K910995)Boston Scientific Corp1991-04-09
VARIOUS TYPES OF STETHOSCOPES (K905487)Liaoning-Usa Corp.1991-04-09
TEGWIRE (TM) (K911203)Boston Scientific Corp1991-04-09
VENAPULSE MODELS VP-25 AND VP-50 (K903894)Aci Medical, Inc.1991-04-03
OCHSNER 500 VASCULAR PROSTHESIS (K905269)Intervascular, Inc.1991-04-02
CONDOR ANALOG INFLATION SYRINGE (K904508)Professional Medical Services1991-04-02
KELLER VITAL SIGNS MONITOR - KMS-890 (K910262)Keller Medical Specialties Products, Inc.1991-04-01
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS (K910208)Baxter Healthcare Corp1991-04-01
EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS (K910864)Vascutek, Ltd.1991-04-01
ENTREE SHEATH INTRODUCER SYSTEM (K904475)Cordis Corp.1991-04-01
E-Z-EM PULSED INFUSION SYSTEM (K905447)E-Z-Em, Inc.1991-04-01
TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS (K910865)Vascutek, Ltd.1991-04-01
EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS (K910863)Vascutek, Ltd.1991-04-01
VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS (K910866)Vascutek, Ltd.1991-04-01
ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH (K905831)Arzco Medical Electronics, Inc.1991-03-29
FLOWIRE AND FLOMAP (K905411)Cardio Metrics, Inc.1991-03-29
GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE (K910464)W. L. Gore & Associates, Inc.1991-03-26
OWENS CATHETER (K896520)Boston Scientific Corp1991-03-25
VESSEL DILATOR (K905416)The R Group1991-03-25
MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM) (K904410)Meadox Medicals, Div. Boston Scientific Corp.1991-03-25
DYNAMIC SPECTRAL PHONOCARDIOGRAPH (K902185)Reeves Scientific, Inc.1991-03-25
DIAGNOSTIC INTRASCULAR CATHETER (K903848)Applied Vascular Devices, Inc.1991-03-25
STETHOSCOPE (K904547)Kimball Industries Co., Ltd.1991-03-21
FLOSCOPE MICRODOP (K910441)Advance Medical Device, Inc.1991-03-21
VER-MED A10017 UNIVERSAL ELECTRODE (K905489)Vermont Medical, Inc.1991-03-21
CPI MODEL 2215/SEAMED MODEL 3400 (K910223)Seamed Corp.1991-03-19
ACS ANGIOSCOPIC CATHETER (K905715)Advanced Cardiovascular Systems, Inc.1991-03-18
PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT (K905067)Pioneering Technologies, Inc.1991-03-18
ZOEX ANTISHOCK TROUSERS (K904267)Zoex Corp.1991-03-18
PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR (K904988)Palco Laboratories, Inc.1991-03-18
DEFIBRILLATOR ANALYZER MODEL QED-5 (K904159)Bio-Tek Instruments, Inc.1991-03-18
SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM (K905728)Hewlett-Packard Co.1991-03-15
FLOSCOPE VASCULAR LAB. (K905157)Advance Medical Device, Inc.1991-03-15
ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE (K902766)Advanced Ischemia Recorders, Inc.1991-03-12
WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS (K905496)Meadox Medicals, Div. Boston Scientific Corp.1991-03-11
BODY COMPOSITION ANALYZER (K904970)Body Composition Analog, Inc.1991-03-07
CRI CYNOSAR CATHETER (K904785)Catheter Research C/O Burditt, Bowles & Radzius1991-03-06
E-20 RAPID CUFF INFLATOR (K905367)D. E. Hokanson, Inc.1991-03-06
TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 (K904749)Transtracheal Systems1991-03-01
TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 (K904748)Transtracheal Systems1991-03-01
HORIZON 2000 ST ANALYSIS OPTION (K903524)Mennen Medical, Inc.1991-03-01
INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD (K902672)Intermedics, Inc.1991-03-01
PILLING BRUSH VALVULOTOME (K904507)Pilling Co.1991-03-01
CORDIS REFLEX STEERABLE GUIDEWIRE (K905423)Cordis Corp.1991-03-01
MODEL 405 (K904606)Ivy Biomedical Systems, Inc.1991-03-01
NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS (K905248)Advanced Technology Laboratories, Inc.1991-02-28
ES-1000SP II SMART DOP (K903026)Koven and Assoc., Inc.1991-02-26
INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. (K902627)Biometric Research Institute, Inc.1991-02-25
VISTA VIEWING STATION (K904975)Prism Imaging, Inc.1991-02-25
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