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Cardiovascular

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

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RecordFirmDate
VITALERT 2000 VITAL SIGNS MONITOR (K882031)Draeger Medical, Inc.1988-07-28
MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR (K882188)Ivy Biomedical Systems, Inc.1988-07-28
PROPAQ 104(TM) (K882085)Protocol Systems, Inc.1988-07-28
MODEL BPS08 BLOOD PRESSURE MODULE (K881155)Fresenius USA, Inc.1988-07-28
TUNNELING STYLET (K882097)Quinton, Inc.1988-07-28
BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER (K881968)Biodynamics Corp.1988-07-28
LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR (K881153)Physio-Control Corp.1988-07-27
UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE (K881796)Universal Medical Instrument Corp.1988-07-26
ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE (K881787)Advanced Cardiovascular Systems, Inc.1988-07-25
CHANGE TO CATHODE POWDER SPECIFICATION (K881904)Telectronics and Cordis Pacing Systems1988-07-22
MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 (K882429)Tpl-Cordis, Inc.1988-07-22
MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE (K882174)Medtronic Andover Medical, Inc.1988-07-22
CARD GUARD, MODEL CG-2000 (K882290)Card Guard Scientific Survival , Ltd.1988-07-22
SYNCOR (R) MODEL S-801 ECG ELECTRODE (K882216)Lectec Corp.1988-07-20
SIRECUST 1280/1281 & 960/961 PATIENT MONITORS (K881939)Siemens Medical Electronics1988-07-18
STETH-SHIELD ACCESSORY TO A STETHOSCOPE (K882324)Steth-Shield, Inc.1988-07-18
26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP (K882479)Medtronic Blood Systems, Inc.1988-07-18
OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D (K881837)Telectronics, Inc.1988-07-18
SATLITE+/PB251+ PULSE OXIMETER (K881883)Datex Division Instrumentarium Corp.1988-07-18
FRANZ CATHETER (K881853)Ep Technologies, Inc.1988-07-18
EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER (K881820)Edentec Corp.1988-07-18
TRIAD-EP (K880936)Cardiotronics, Inc.1988-07-18
BUBBLE TRAP-FILTER CAT. NO B180F37 (K873316)American Omni Medical, Inc.1988-07-14
WS 800R THERMAL ARRAY RECORDER (K881831)Nihon Kohden America, Inc.1988-07-14
PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101 (K874938)Sp Innovations, Inc.1988-07-12
HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK (K882045)Cordis Leads, Inc.1988-07-12
ESCORT - PORTABLE PATIENT MONITOR (K881986)Medical Data Electronics1988-07-12
HORIZON 2000 ARRHYTHMIA MONITORING OPTION (K881273)Mennen Medical, Inc.1988-07-12
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR (K882513)Cardiac Resucitator Corp.1988-07-12
SHILEY FEMORAL CORONARY PERFUSION CATHETER (K881733)Shiley, Inc.1988-07-06
PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE) (K881717)Buckman Co., Inc.1988-07-05
PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA (K881691)Shiley, Inc.1988-07-05
SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER (K881734)Shiley, Inc.1988-07-05
#557 DISPOSABLE CARDIOVASCULAR CLAMP (K881448)Alpha Industries, Inc.1988-06-30
RIGEL MODEL MULTICARE 409 (K875160)Rigel Medical Electronics, Inc.1988-06-28
VEN-A-CATH PERCUTANEOUS VENOUS CATHETER KIT (K881504)Hdc Corp.1988-06-22
METATECH METAL MICROCLIP (K881447)Metatech Corp.1988-06-22
ACCUSTAT MODEL 102 NON-INVASIVE BLOOD MONITORING (K881272)Accustat, Inc.1988-06-22
MINI-TEMP(TM) (K881322)Seabrook Medical Systems, Inc.1988-06-22
TRANSONIC FLOWMETER (K872048)Transonic Systems, Inc.1988-06-21
C-FLO SUCTION TUBE (K882121)Concept, Inc.1988-06-20
VASCULAR CLAMP (K881158)T. Korossurgical Instruments Corp.1988-06-20
ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201 (K874366)Cordis Leads, Inc.1988-06-16
OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-701C (K881269)Omron Electronics, Inc.1988-06-16
WITT BIOMEDICAL VX-80 (K880258)Witt Biomedical Corporation1988-06-16
MX1002 CABLE-CAL TM (K880696)Medex, Inc.1988-06-15
BIOLOGICAL OHM METER, BES 200Z (K880926)Bioelectrical Sciences, Inc.1988-06-15
EMBOLECTOMY CATHETER(MODIFIED) (K881455)Cathlab Corp.1988-06-15
OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM703C (K881602)Omron Tateisi Electronics Co.1988-06-15
OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403C (K881601)Omron Tateisi Electronics Co.1988-06-15
MONITRON SYSTEM (K874148)American Health Products, Inc.1988-06-15
EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116 (K881449)Baxter Healthcare Corp1988-06-15
AMBULATORY BLOOD PRESSURE MONITOR (K873764)Pulsetrend, Inc.1988-06-10
DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL (K880289)Datascope Corp.1988-06-10
VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT (K880041)D-R Medical Systems, Inc.1988-06-10
COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK (K881330)Cobe Laboratories, Inc.1988-06-10
SHILEY FEMORAL CANNULAE INTRODUCER KIT (K881073)Shiley, Inc.1988-06-09
VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT (K880040)D-R Medical Systems, Inc.1988-06-09
RIGHT ATRIAL CATHETER INSERTION TRAY (K881352)Quinton, Inc.1988-06-09
DISPOSABLE CATHETER PRESSURE TRANSDUCER (K874165)Deseret Medical, Inc.1988-06-09
LIFESTAT 1600 PRINTER (K881346)Physio-Control Corp.1988-06-09
WORKSTATION PLUS W/LOCAL AREA NETWORK(LAN) OPTION (K880879)Ppg Industries, Inc.1988-06-02
ACCUCOM 2 (K874138)Datascope Corp.1988-06-01
APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300 (K873214)General Electric Co.1988-06-01
ACS FUNNEL INTRODUCER (K875158)Advanced Cardiovascular Systems, Inc.1988-05-31
CARDICAD(TM) (K881392)Medical/Surgical Specialties, Ltd.1988-05-31
EPICARDIA LE/FD (K881770)Medicomp, Inc.1988-05-31
IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 (K874664)Telectronics, Inc.1988-05-31
HORIZON 9000 (K875167)Mennen Medical, Inc.1988-05-31
MODIFIED SERVO SYRINGE (K881521)Engineering, Inc.1988-05-31
SHILEY FEMORAL VENOUS CANNULA (K881074)Shiley, Inc.1988-05-31
SHILEY FEMORAL ARTERIAL CANNULA (K881072)Shiley, Inc.1988-05-31
CONTRAST INJECTION DEVICE (K880877)Med-West, Inc.1988-05-31
ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM) (K881088)Devices For Vascular Intervention, Inc.1988-05-31
MEADOX INTRA-AORTIC GRAFT (K881283)Meadox Medicals, Div. Boston Scientific Corp.1988-05-26
CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 (K880860)Dlp, Inc.1988-05-26
VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA. (K881711)Telectronics and Cordis Pacing Systems1988-05-26
OCHSNER & MICRON FABRIC PATCH (K881508)Intervascular, Inc.1988-05-25
MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER (K880231)Ideas For Medicine, Inc.1988-05-25
MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT (K881712)Medtronic Vascular1988-05-25
SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD (K874465)Abbott Laboratories1988-05-25
MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD (K875178)Intermedics, Inc.1988-05-25
HEPARIN COATED LUMINAL PACING CATHETER (K875337)Spectramed, Inc.1988-05-25
STOCKERT-SHILEY BUBBLE MONITOR 23-23-01 (K881006)Shiley, Inc.1988-05-24
MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD (K875100)Intermedics, Inc.1988-05-24
NEOCATH (K880887)Taris Corp.1988-05-24
8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM (K880777)Medsurg Industries, Inc.1988-05-24
BIOSOUND MMI ULTRASOUND (K871442)Biosound, Inc.1988-05-20
EXTERNAL PACEMAKER WIRE DRESSING CHANGE (K881356)Neal & Assoc., Inc.1988-05-19
GORE-TEX VASCULAR GRAFT (K880167)W. L. Gore & Associates, Inc.1988-05-18
MODEL 375 ECG (K881328)Birtcher Corp.1988-05-18
EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET (K881279)Baxter Healthcare Corp1988-05-18
INTRA-AORTIC BALLOON PUMP MODEL KAAT (K875036)Kontron Instruments, Inc.1988-05-18
GORE-TEX VASCULAR GRAFT (K881732)W. L. Gore & Associates, Inc.1988-05-18
DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1 (K881003)Healthcheck Corp.1988-05-18
HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI. (K881136)Hewlett-Packard Co.1988-05-18
BATTERY PACKS FOR CARDIOVASCULAR UNITS (K881643)Dowit Service Co., Inc.1988-05-17
SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER (K881197)Schneider-Shilley (Usa)1988-05-16
VASCU-CARE ANGIOSCOPE (K880927)Vascu-Care, Inc.1988-05-16
PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101 (K875118)Bloodflow Laboratory, Inc.1988-05-16
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