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Cardiovascular

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

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RecordFirmDate
FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES (K850897)Fukuda Denshi USA, Inc.1985-04-10
COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER (K850139)Rapid Diagnostic Laboratories, Inc.1985-04-10
CORONARY INFUSION CATHETER W/SIDEHOLES (K850353)Advanced Cardiovascular Systems, Inc.1985-04-10
DIAGNOSTIC ULTRASOUND 105 & 110 (K842539)Diagnostic Ultrasound Corp.1985-04-10
DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC (K850132)Consolidated Medical Equipment, Inc.1985-04-09
CARDIO-NEC MODEL 365 (K844101)Birtcher Corp.1985-04-09
MODEL 78231D CARDIAC OUTPUT MODULE (K850568)Hewlett-Packard Co.1985-04-09
RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE (K850365)Eaton Medical Group1985-04-09
PRN ECG ELECTRODE (K850130)Consolidated Medical Equipment, Inc.1985-04-09
IAI PROGRAM-COMPUTER PROGRAM (K844997)Intl. Acoustics, Inc.1985-04-09
IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II (K851081)Telectronics, Inc.1985-04-04
QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR (K850252)Telectronics, Inc.1985-04-04
KONTRON MINIMON 7134 PATIENT MONITOR (K844215)Kontron Instruments, Inc.1985-04-04
ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS. (K844988)Ethox Corp.1985-04-04
MODEL 492-01 PACEMAKER LEAD (K813136)Intermedics, Inc.1985-04-03
INTERMEDICS POLYFLEX PACING LEAD #480-01 (K820267)Intermedics, Inc.1985-04-03
PUL,MONARY ARTERY VENT CATHETER (K845046)Dlp, Inc.1985-04-03
ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR (K850271)Angiomedics, Inc.1985-04-03
PROGRAMMABLE PATIENT SIMULATOR (K844464)Ramford Labs1985-04-03
POLY FLEX IMPLANTABLE PACING LEAD (K802294)Intermedics, Inc.1985-04-03
MODEL 486-01 PACEMAKER LEAD (K813135)Intermedics, Inc.1985-04-03
VENOUS RETURN CATHETER SS-1 (K845045)Dlp, Inc.1985-04-03
PHYSIOLOGICAL MONITOR 2100 (K844353)Datascope Corp.1985-04-01
PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR (K850651)Pacesetter Systems1985-04-01
DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX (K844839)Critikon Company, LLC1985-04-01
NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER (K850487)Novametrix Medical Systems, Inc.1985-03-29
MODEL 483-03 PACING LEAD (K844268)Intermedics, Inc.1985-03-28
MODEL 493-01 PACING LEAD (K844263)Intermedics, Inc.1985-03-28
MODEL 493-03 PACING LEAD (K844264)Intermedics, Inc.1985-03-28
MODEL 483-02 PACING LEAD (K844269)Intermedics, Inc.1985-03-28
MODEL 483-01 PACING LEAD (K844262)Intermedics, Inc.1985-03-28
MODEL 495-01 PACING LEAD (K844265)Intermedics, Inc.1985-03-28
MODEL 483-01 PACING LEAD (K844267)Intermedics, Inc.1985-03-28
OHMEDA BIOX 3700 PULSE OXIMETER (K850494)Ohmeda Medical1985-03-28
MODEL 473-03 PACING LEAD (K844272)Intermedics, Inc.1985-03-28
MODEL 480-01 PACING LEAD (K844270)Intermedics, Inc.1985-03-28
MODEL 490-01 PACING LEAD (K844261)Intermedics, Inc.1985-03-28
MODEL 476-03 PACING LEAD (K844260)Intermedics, Inc.1985-03-28
MODEL 479-01 PACING LEAD (K844271)Intermedics, Inc.1985-03-28
MODEL 492-01 PACING LEAD (K844266)Intermedics, Inc.1985-03-28
MODEL 486-01 PACING LEAD (K844259)Intermedics, Inc.1985-03-28
BLOOD OXYGENATOR MODEL NO. MAX-5 (K850630)American Bentley1985-03-27
ELECATH OPEN TIP BIPOLAR PACING CATHETER (K850324)Electro-Catheter Corp.1985-03-27
KONTRON MINIMON 7132 PATIENT MONITOR (K844732)Kontron Instruments, Inc.1985-03-27
PATHFINDER CARDIOVASCULAR CATHETER (K844555)Argon Medical Corp.1985-03-27
KONTRON MINIMON 7131 PATIENT MONITOR (K844733)Kontron Instruments, Inc.1985-03-27
CORDIS ENCOR PERVENOUS ATRIAL & VENTRICULAR LEADS (K844970)Cordis Corp.1985-03-27
PRESSURE MONITORING KIT (K842352)Utah Medical Products, Inc.1985-03-25
UTAH DISPOSABLE PRESSURE TRANSDUCER (K841788)Utah Medical Products, Inc.1985-03-25
CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER (K850384)Cardiac Control Systems, Inc.1985-03-21
SCANHEADS ACCESS 10 10PV B10 (K843953)Advanced Technology Laboratories, Inc.1985-03-12
SCANHEADS-ACCESS 10PV, BIOSTATIC (K843620)Advanced Technology Laboratories, Inc.1985-03-12
AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH (K844901)American Bentley1985-03-07
PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR (K850576)Pacesetter Systems1985-03-06
PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY & (K850596)Cardiac Resucitator Corp.1985-03-06
MEDTRONIC 5061 ENDOCARDIAL PACING LEAD (K844974)Medtronic Vascular1985-03-06
PEEL-AWAY INTRODUCER SET (K844693)Quinton, Inc.1985-03-06
ELECATH CARDIAC OUTPUT COMPUTER (K844682)Electro-Catheter Corp.1985-03-06
ACCESS C (K843911)Advanced Technology Laboratories, Inc.1985-03-05
CALCULATING CUFF INFLATOR TD312 (K842067)D. E. Hokanson, Inc.1985-03-01
BRENTWOOD EZ SCAN 200 AMBULATORY ECG (K842976)Brentwood Instruments, Inc.1985-03-01
DISPOSABLE ECG ELECTRODE (K841944)Bristol Medical Electronics Corp.1985-03-01
PHONOANGIOGRAPHIC SPECTRAL ANALYZER (K840169)Biotronics Instruments1985-03-01
COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM (K850656)Cook Pacemaker Corp.1985-03-01
MONITORING SYSTEM M720 (K842944)Burdick Corp.1985-03-01
ECG PATIENT MONITOR 302 (K850155)Rigel Medical Electronics, Inc.1985-03-01
ELECTROCARDIOGRAM DISPOS. ELECTRODE PAD (K842514)Multi Biosensors, Inc.1985-03-01
ACCUTORR CSM SYSTEM (K842538)Datascope Corp.1985-03-01
LS 5 (K842037)Life Science Instrumentation, Inc.1985-03-01
CARDIO-3 CHANNEL ELECTROCARDIOGRAPH (K850454)Zimmer Elektromedizin GmbH1985-03-01
EKG TRANSMITTER MODEL 5134 (K842051)Instromedix, Inc.1985-03-01
ECG PATIENT MONITOR 301 (K850156)Rigel Medical Electronics, Inc.1985-03-01
DISPOSABLE ECG ELECTRODES EASATRACE (K850085)Medical Device Marketing1985-02-27
PRUITT-VASCULAR SHUNTS (K850356)Ideas For Medicine, Inc.1985-02-27
CARDIOVASCULAR SET UP (K850341)Marwood Medical, Inc.1985-02-25
CARDIAC CATHETERIZATION PACK (K850337)Marwood Medical, Inc.1985-02-25
C/PES 9201, ECG STRESS TESTING SYS (K850114)Gould, Inc.1985-02-22
ARIES MEDICAL PERFLEX PERCUTANEOUS 40CC D/L BALLOO (K844220)Aries Medical, Inc.1985-02-20
PERIFLUX PF-2 (K844631)Medex, Inc.1985-02-20
ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON (K844856)Bristol Medical Electronics Corp.1985-02-20
OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR (K844277)Omikron Scientific, Ltd.1985-02-15
PTCA BALLOON CATHETERS & ACCESSORIES (K843944)Advanced Cardiovascular Systems, Inc.1985-02-14
CARDIOTOMY RESERVOIR BRS-XXX SERIES & (K843888)Gish Biomedical, Inc.1985-02-14
PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD (K844857)Pacesetter Systems1985-02-14
HEART AID MODEL 97 (K850170)Cardiac Resucitator Corp.1985-02-14
SPACELABS MODEL 90201 HOLTER RECORDER (K844940)Spacelabs, Inc.1985-02-14
CARDIOTOMY RESERVOIR W/FILTER (K843595)Omnis Surgical, Inc.1985-02-14
YKI-770 ELECTRONIC SPHYGMOMAMETER (K842318)Yukosha Co., Inc.1985-02-14
COPAL DIGITAL SPHYGMOMANOMETER UA-510 (K842388)Takeda Medical, Inc.1985-02-13
COMPUTER (K844665)Burdick Corp.1985-02-13
LIFESOUND - ELECTRONIC STETHOSCOPE (K844804)Biomedical Concepts, Inc.1985-02-13
MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT (K844740)Hewlett-Packard Co.1985-02-12
SIREDOC, PAPER CHART RECORDER (K850146)Siemens Medical Solutions USA, Inc.1985-02-12
COPAL DIGITAL SPHYGMOMANOMETER UA-540 (K844284)Takeda Medical, Inc.1985-02-08
IABP #90 SYSTEM (K831235)Datascope Corp.1985-02-08
CARDIOBEEPER PROFILE MONITOR (K844966)Survival Technology, Inc.1985-02-08
MDE ESCORT 1000 & MDE ESCOR 2000 (K842716)Medical Data Electronics1985-02-08
SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR (K844793)Intermedics, Inc.1985-02-08
BIOPATCH BOVINE PERICARDIAL PATCH (K840756)Meadox Medicals, Div. Boston Scientific Corp.1985-02-08
ELECTROCARDIOGRAPH-ECG CALIPER (K850021)Devcom, Inc.1985-02-08
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