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Cardiovascular

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

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RecordFirmDate
COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER (K853651)Cook Pacemaker Corp.1985-10-23
MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417 (K850165)Hoffrel Instruments, Inc.1985-10-23
#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER (K852971)Medtronic Vascular1985-10-22
SENSOR TAPE CAT. NO. ST-45 (K852407)American Omni Medical, Inc.1985-10-21
ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO (K853746)Advanced Cardiovascular Systems, Inc.1985-10-21
REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE (K853860)Quinton, Inc.1985-10-18
GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX (K851486)Gould, Inc.1985-10-17
SARNS EVACUPLEGE CATHETER (K853128)3M Health Care, Sarns1985-10-17
J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO (K853251)Johnson & Johnson Professionals, Inc.1985-10-16
WILLIAM HARVEY HYBID OXYGENATOR H-1700 (K853080)C.R. Bard, Inc.1985-10-11
SHILEY CSD EXTENSION LINE WITH FILTER (K852984)Shiley, Inc.1985-10-11
MEDTRONIC MODEL 6405 (K853818)Medtronic Vascular1985-10-11
MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD (K853410)Intermedics, Inc.1985-10-11
FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON (K853213)Fukuda Denshi USA, Inc.1985-10-11
PACEPAC (K852958)Medical Data Electronics1985-10-11
MODEL 43130A DEFIBRILLATOR (K853439)Hewlett-Packard Co.1985-10-11
IPG-300 (K852238)Thornton Associates, Inc.1985-10-11
MEDIC 4 (K853354)Kone Instruments, Inc.1985-10-11
ANGIOMEDICS SOFTIP CATHETER (K852872)Angiomedics, Inc.1985-10-11
BIO PACK MODEL 200 (K853126)Bio Medicus, Inc.1985-10-11
CARDIO DATA PACERECORDER PR3 (K853262)Cardio Data1985-10-11
LIFEPAK 200 (K853564)Physio-Control Corp.1985-10-11
ELECTROCARDIOGRAPH (K852181)Armstrong Ind., Inc.1985-10-09
SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER (K852281)Armstrong Ind., Inc.1985-10-09
SCHILLER MINISCOPE MS-2 EKG SCOPE (K852282)Armstrong Ind., Inc.1985-10-09
LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD (K853520)Intermedics, Inc.1985-10-08
CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO (K851517)Circadian, Inc.1985-10-02
IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A (K852708)Telectronics, Inc.1985-10-01
MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD (K853411)Intermedics, Inc.1985-10-01
BIO MEDICUS BIO PUMP MODEL BP-80 (K852698)Bio Medicus, Inc.1985-09-30
BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV) (K852780)Shiley, Inc.1985-09-30
BIO MEDICUS BIO PUMP MODEL BP-50 (K852807)Bio Medicus, Inc.1985-09-30
DUNN VESSEL OCCLUDER-STERILE (K851739)Richard J. Turner Assoc.1985-09-27
TRAUMA CARE EVALUATION (K843905)Quantitative1985-09-26
COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT (K853100)Cobe Laboratories, Inc.1985-09-25
CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR (K852382)American Bentley1985-09-25
AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER (K852491)American Pharmaseal Div. Ahsc1985-09-25
ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION (K852914)Norton Performance Plastics Corp.1985-09-25
CVERNE CAD DETECTOR (K852900)Cherne Industries, Inc.1985-09-25
METRONIC MODEL F7700 HEART VALVE SIZERS (K852612)Medtronic Vascular1985-09-23
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM (K852543)Kontron Instruments, Inc.1985-09-20
FUKUDA DENSHI MODEL AU-5001-5003 THERMAL (K852487)Fukuda Denshi USA, Inc.1985-09-19
IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A (K852709)Telectronics, Inc.1985-09-17
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401 (K853221)Telectronics, Inc.1985-09-17
ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP (K852446)Diag Corp.1985-09-17
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402 (K853222)Telectronics, Inc.1985-09-17
TELEFLEX GUIDEWIRE (K850677)Teleflexmedical, Inc.1985-09-17
BARD-PARKER OCCLUSION BALLOON CATHETER (K852294)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-09-17
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407 (K853223)Telectronics, Inc.1985-09-17
SAF-D-FIB (K852469)Medtronic Andover Medical, Inc.1985-09-16
HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE (K852797)Mansfield Scientific, Inc.1985-09-16
CARBOCONE (K851732)Imtech Corp.1985-09-16
IMPLANTABLE ELECTRODE LEAD, MODEL 030-400 (K852972)Telectronics, Inc.1985-09-16
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD (K852513)C.R. Bard, Inc.1985-09-16
HEMATOCRIT-SATURATION MONITOR HSM-100 (K852124)American Bentley1985-09-16
2006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR) (K852799)Cardiac Recorders, Ltd.1985-09-16
GAMBRO DIGITAL TELETHERMOMETER TTH 10-200 (K852455)Gambro, Inc.1985-09-16
CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO) (K852808)Cardiac Recorders, Ltd.1985-09-16
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA (K851913)Cordis Corp.1985-09-16
TEMPORARY PACEMAKER GROUND WIRE (K852119)Scholten Surgical Instruments, Inc.1985-09-15
NEOS - M ABP (K853058)Biotronik Sales, Inc.1985-09-13
EXTERNAL PACEMAKER TELECTRONICS TE200 (K852746)Seamed Corp.1985-09-12
IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW (K853206)Telectronics, Inc.1985-09-12
TRIOS - M (K853057)Biotronik Sales, Inc.1985-09-12
NORELCO ELECTRONIC DIGITAL BP METER HC3501 (K852128)Philips Park1985-09-12
MODEL 78560A CENTRAL STATION PATIENT INFO SYS (K852514)Hewlett-Packard Co.1985-09-12
VSM-5 (K852322)Physio-Control Corp.1985-09-11
BENTLEY-TRANTEC DISPOS. DOMES D-260- (K841811)American Bentley1985-09-09
REMOTE CONTROL MODULE (K851643)Circadian, Inc.1985-09-09
COPAL DIGITAL SPHYGMOMANOMETER UA-560 (K851223)Takeda Medical, Inc.1985-09-09
ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860 (K851731)Ela Medical, Inc.1985-08-29
BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD (K844814)Intermedics, Inc.1985-08-29
PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET) (K852880)Argon Medical Corp.1985-08-29
NUMED TEMP. STYLET PACING PAROBE 1318694 (K851845)NuMED, Inc.1985-08-29
MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN (K850968)Medtronic Vascular1985-08-29
DEFI 502 (K851485)Robert Bosch Corp.1985-08-29
TRIPLE LUMEN RIGHT ATRIAL CATHETER (K852815)Quinton, Inc.1985-08-26
MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT (K852388)Quinton, Inc.1985-08-22
DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO (K850482)Datascope Corp.1985-08-22
CORDIS PTA CATHETER-PERCUTANEOUS CATHETER (K844913)Cordis Corp.1985-08-20
DOME, DISPOSABLE, STERILE (K851989)Transamerica Delaval, Inc.1985-08-19
COPAL UA-512 DIGITAL BLOOD PRESSURE MONITOR (K852564)Takeda Medical, Inc.1985-08-19
DESERET THERMODILUTION CARDIAC OUTPUT (K841967)Parke-Davis Co.1985-08-19
ECS 502 (K840717)Robert Bosch Corp.1985-08-19
VSM MODELS A & B (K851916)Physio-Control Corp.1985-08-19
CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR (K853425)Cardio-Pace Medical, Inc.1985-08-19
PTCA GUIDING CATHETER (K851947)Cordis Corp.1985-08-16
ADMINISTRATION SET (K851988)Transamerica Delaval, Inc.1985-08-16
FLUSH DEVICE, AUTOMATIC (K851987)Transamerica Delaval, Inc.1985-08-16
TECA TC2-64 TRANSCRANIAL DOPPLER (K850137)Teca, Inc.1985-08-14
AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU (K851323)C.R. Bard, Inc.1985-08-12
CAPIOX BLOOD SAMPLING MANIFOLD (K852086)Terumo Medical Corp.1985-08-09
CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD (K851897)Cardiac Control Systems, Inc.1985-08-09
BARD-PARKER IRRIGATION CATHETER (K852099)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-08-09
PRESSURE DISPLAY BOX #60000/TUBING SET #61000 (K852232)Dlp, Inc.1985-08-09
FOAM ECG ELECTRODES (K852177)Clinical Data, Inc.1985-08-09
PULMONARY VEIN CLAMP (K852479)None1985-08-09
CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA (K852435)Cardiac Control Systems, Inc.1985-08-06
MEDTRONIC MODEL 5561 (K852356)Medtronic Vascular1985-08-06
LITEGUARD 9 (K851924)Temtech , Ltd.1985-08-06
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