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Cardiovascular

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

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RecordFirmDate
CARDIOGUARD STRESS TEST MONITOR 4002 (K850043)Del Mar Avionics1985-02-08
MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE (K844958)Medtronic Vascular1985-02-08
PERCOR 9.5 FR IAB ON DATASCOPE CO2 (K833828)Datascope Corp.1985-02-08
C/PES 9103, ECG STRESS TESTING SYSTEM (K850113)Gould, Inc.1985-02-08
MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR (K844957)Medtronic Vascular1985-02-08
BIOTRONIK DNP UNIPOLAR (K841450)Biotronik Sales, Inc.1985-02-07
QUIKPAGE ARRHYTHMIA REPORT GENERATOR (K841083)Agilent Technologies1985-02-07
BIOTRONIK DY-UNIPOLAR (K841451)Biotronik Sales, Inc.1985-02-07
SURGICAL MODULE 7000 ECG (K840869)Marquette Electronics, Inc.1985-02-06
ARRHYTHMIA SYSTEM AC-11 (K841084)Fukuda Denshi USA, Inc.1985-02-01
MEDTRONIC MODEL 6912 (K844687)Medtronic Vascular1985-02-01
CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM (K850136)Cardio Data1985-02-01
SEAMED MODEL 6000 (K843807)Seamed Corp.1985-02-01
LARIAT CATHETER (K844598)Mallinckrodt Critical Care1985-02-01
SEAMED 4000 (K843777)Seamed Corp.1985-02-01
MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC (K840037)Smec, Inc.1985-02-01
PULSE-AID DEVICE (K843977)James J. Lally1985-02-01
CARDIAC COMPUTER SP1445 (K843555)Gould, Inc.1985-02-01
VARIABLE PRIME COBE MEMBRANE LUNG (K842908)Cobe Laboratories, Inc.1985-02-01
SPACELABS SERIES 600 PATIENT MONITORS (K844888)Spacelabs, Inc.1985-02-01
COLOR DOPPLER 880 (K843643)Irex Corp.1985-01-31
GORE-TEX TUNNELER (K844584)W. L. Gore & Associates, Inc.1985-01-24
PACE AID MODEL 53 (K844811)Cardiac Resucitator Corp.1985-01-24
CARDIOVIT CV-3 (K841254)Schiller AG1985-01-24
CARDIO IV/GXT STRESS TESTING SYSTEM (K844744)Intl. Medical, Inc.1985-01-23
MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER (K843969)Gould, Inc.1985-01-23
MX2 ELECTRONIC STETHOSCOPE (K842705)Medmax, Inc.1985-01-23
DR-2C (K844650)General Devices1985-01-22
HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2 (K850070)Healthcheck Corp.1985-01-22
EPICARDIAL, UNIPOLAR LEAD 4951 (K842065)Medtronic Vascular1985-01-18
ARRHYTHMIA CENTRAL-OGP-7201 (K844911)Nihon Kohden America, Inc.1985-01-18
CARDIOPAC DEFIBRILLATOR 444 (K844103)Birtcher Corp.1985-01-18
PATIENT MONITOR 78354A (K842236)Hewlett-Packard Co.1985-01-18
MODELS 4012/4512 TRANSVENOUS TINED- (K842032)Medtronic Vascular1985-01-18
TRANSVENOUS TINED VENTRICULAR/ATRIAL (K842031)Medtronic Vascular1985-01-18
TRANSVENOUS TINED VENTRICULAR LEAD (K842145)Medtronic Vascular1985-01-18
BP 5000 (K843137)Tech Vend Marketing1985-01-16
RIGHT VENTRICULAR EJECTION FRACTION- (K842105)American Edwards Laboratories1985-01-15
CARDIOTOMY RESERVOIR BCR-2000 (K844366)American Bentley1985-01-14
M/D4 W/CHARGER (CARDIOPAC 3M11) (K844447)Datascope Corp.1985-01-14
SHILEY HARDSHELL VENOUS RESERVOIR W/INT (K843232)Shiley, Inc.1985-01-14
VENOUS RESERVOIR VRS-XXX SERIES; HOLDER VRS-HXX (K844229)Gish Biomedical, Inc.1985-01-14
HOLTER CURA-LITE RECORDER (K844977)Cardionostics, Inc.1985-01-14
SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER (K841401)American Edwards Laboratories1985-01-14
CARDIOTOMY RESERVOIR W/FILTER BCR-2500 (K844367)American Bentley1985-01-14
INFANT LIMB ELECTRODE (K844632)Sentry Medical Products, Inc.1985-01-14
NUMED BALLOON PACING CATHETER (K843290)NuMED, Inc.1985-01-14
HORIZON ECG SYSTEM (K823844)Beckman Instruments, Inc.1985-01-10
VIVALITH II 301 PULSE GENERATOR (K844334)Pacesetter Systems1985-01-10
FUKUDA DENSHI MODEL FCP-220 (K844470)Brentwood Instruments, Inc.1985-01-10
MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN (K844959)Medtronic Vascular1985-01-10
MULTILITH PULSE GENERATORS, 1141 & 2141 (K842193)Ela Medical, Inc.1985-01-10
MODEL 78210A TELEMETRY TRANSMITTER (K844376)Hewlett-Packard Co.1985-01-10
HEPARIN COATED ARTERIAL BLOOD FILTERS (K842813)American Bentley1985-01-08
SCIMED II MEMBRANE OXYGENATOR SYSTEM (K843956)Scimed Life Systems, Inc.1985-01-08
LIGHT REFLECTION RHEOGRAPHY (K833561)Instru-Med, Inc.1985-01-08
PERMATHANE 865 & 867 UNIPOLAR POLYURETH (K843703)Pacesetter Systems1985-01-08
MEDTRONIC 6957J (K843707)Medtronic Vascular1985-01-08
NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS (K844391)Ams Medical, Inc.1985-01-07
CONTOUR ELECTRODE (K844345)Heuristic Medical Systems, Inc.1985-01-02
ELECATH GALLAGHER MAPPING CATHETER (K844805)Electro-Catheter Corp.1985-01-02
TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA (K844752)Mansfield Scientific, Inc.1985-01-02
ELECTROCARDIOGRAPH ELECTRODE (K844335)Meditect1985-01-02
PTCA GUIDING CATHER (K844161)Cordis Corp.1985-01-02
HYDROGLIDE SPRING GUIDE WIRES (K841926)Argon Medical Corp.1985-01-02
FILTER PURGE LINE EC-FPL SERIES (K833644)Gish Biomedical, Inc.1984-12-29
VENOUS RESERVOIR-BMR-1500-HARD SHELL (K842373)American Bentley1984-12-27
STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN (K844137)Shiley, Inc.1984-12-27
ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH (K844003)Electro-Catheter Corp.1984-12-27
MYOCARDIAL INSULATOR (K843983)Norton Texas Medical Products1984-12-27
MEADOX SURGIMED A/S CATHETER SHEATH SYS (K843798)Meadox Surgimed, Inc.1984-12-27
ECG PATIENT MONITOR (K843376)Rigel Medical Electronics, Inc.1984-12-27
STOCKERT-SHILEY INTRACARDIAC SUCKERS (K844139)Shiley, Inc.1984-12-27
CORDIS ENCOR ATRIAL LEAD (K811259)Cordis Corp.1984-12-27
STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR (K843802)Shiley, Inc.1984-12-27
CANMED 101 (K844100)Medtronic Vascular1984-12-27
CANMED 102 (K844099)Medtronic Vascular1984-12-27
MEDTRONIC 6957 (K843706)Medtronic Vascular1984-12-27
NELLCOR PULSE OXIMETER N-10 (K844256)Nellcor, Inc.1984-12-27
STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH (K844140)Shiley, Inc.1984-12-27
STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI (K844138)Shiley, Inc.1984-12-27
ACCESS & 72X ULTRASOUND SCANHEAD UM4 (K843131)Advanced Technology Laboratories, Inc.1984-12-20
ULTRASOUND 72X & ANNULAR ARRAY SCAN- (K843165)Advanced Technology Laboratories, Inc.1984-12-20
COMPUSTRESS STRESS TESTING SYS (K842339)Intl. Medical, Inc.1984-12-19
PACE *AID MODEL 52 (K843547)Cardiac Resucitator Corp.1984-12-17
DEL MAR AVIONICS 509 NEUROCORDER AMBUL (K841654)Del Mar Avionics1984-12-11
CARE 5000 CENTRAL MONITOR MS5220 ETC. (K842582)Care Monitoring Systems1984-12-11
PAGE-WRITER INTERPRETIVE CARDIOGRAPH (K842370)Hewlett-Packard Co.1984-12-07
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4 (K843130)Advanced Technology Laboratories, Inc.1984-12-06
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8 (K843129)Advanced Technology Laboratories, Inc.1984-12-06
DYNASCOPE MONITOR DS-800 (K844348)Fukuda Denshi USA, Inc.1984-12-04
PULSE GENERATOR 689, 689B & 689L (K841225)Siemens Elema AB1984-12-03
PULSE GENERATOR 686, 686B 686L (K841230)Siemens Elema AB1984-12-03
PULSE GENERATOR 696, 696B & 696L (K841232)Siemens Elema AB1984-12-03
EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR (K843955)Extracorporeal Medical Specialities, Inc.1984-11-29
MULTILITH 2 PULSE GENERATOR 1141 & 2141 (K842220)Ela Medical, Inc.1984-11-29
WIREGUIDE OR GUIDEWIRE (K843012)Medi-Tech, Inc.1984-11-29
SCATAID (K842706)Sc Applied Technology, Inc.1984-11-27
LOW PROFILE STEERABLE BALLOON DILATION (K843880)Advanced Cardiovascular Systems, Inc.1984-11-27
BIPOLAR ENDOCARDIAL LEAD 406L (K841227)Siemens Elema AB1984-11-27
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