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Cardiovascular

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

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RecordFirmDate
ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING (K864262)Johnson & Johnson Professionals, Inc.1987-01-02
BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600 (K864235)C.R. Bard, Inc.1987-01-02
2200I PHYSIOLOGICAL MONITOR (K863308)Datascope Corp.1987-01-02
VEIN VALVE CUTTER (K862724)American Edwards Laboratories1987-01-02
EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER (K864007)Uresil Corp.1987-01-02
MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE (K862459)Medtronic Vascular1987-01-02
NELLCOR MVP, MODEL N-1000 (K862812)Nellcor, Inc.1986-12-22
KENZ-ECG 102 (K863965)Compumed, Inc.1986-12-22
HEALTHPHONE(TM) (K862668)Carelink1986-12-22
NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 (K863494)Advantage Medical Systems, Inc.1986-12-22
M700 STRESS MONITOR (K863466)Kone Instruments, Inc.1986-12-22
NBP 488, TPR 488 (K861856)Siemens Medical Solutions USA, Inc.1986-12-22
MODIFIED VSM 2 VITAL SIGNS MONITOR (K864665)Physio-Control Corp.1986-12-11
MODIFIED SARNS MEMBRANE OXYGENATOR (K863902)3M Health Care, Sarns1986-12-11
STOCKERT-SHILEY CAPS BATTERY MODULE (K863960)Shiley, Inc.1986-12-11
MODIFIED LIFESTAT 200 (K864666)Physio-Control Corp.1986-12-11
NEOS-M VS-1 PULSE GENERATOR (K863879)Biotronik Sales, Inc.1986-12-10
SEA MED MODEL 6000 (K863903)Seamed Corp.1986-12-10
MODEL 456 ELECTROCARDIORECORDER RECORDER (K863652)Del Mar Avionics1986-12-10
TRIOS-M VS-1 PULSE GENERATOR (K863878)Biotronik Sales, Inc.1986-12-10
Q-SCAN II AND Q-SCAN III (K864149)Quinton, Inc.1986-12-10
EM II STRESS TEST ELECTRODE (K863584)Electromed Intl., Ltd.1986-12-08
CRITICALC (K860854)Cygnus of South Florida, Inc.1986-12-08
EM II DISPOSABLE ELECTRODE (K863540)Electromed Intl., Ltd.1986-12-08
MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER (K864428)Intermedics, Inc.1986-12-05
ULTRA SOFTWARE MODULE: MODEL 2016 (K863046)Cardiac Pacemakers, Inc.1986-12-05
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC (K862463)Nihon Kohden America, Inc.1986-12-05
AVTECH LWP*(LOW POROSITY) MWP*(MEDIUM POROSITY) (K862697)Advanced Vascular Technologies, Inc.1986-12-05
ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH (K864585)Advanced Cardiovascular Systems, Inc.1986-12-05
MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD (K864564)Intermedics, Inc.1986-12-05
TELECTRONICS SREW-IN/SLIM LINE PACING LEADS (K864098)Daig Corp.1986-12-05
DSP100 AMPLIFIER (K860814)Intl. Acoustics, Inc.1986-12-05
EPICARDIA, PC/FD (K863643)Medicomp, Inc.1986-12-05
DIGITAL PULSE METER HRM-100E & ETC. (K850449)Sanyo Electric, Inc.1986-12-04
VELCOM-100 (K863210)Waters Instruments, Inc.1986-11-26
D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM (K863230)Dextra Medical, Inc.1986-11-25
SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO (K863476)Scimed Life Systems, Inc.1986-11-25
SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1 (K864506)Spacelabs, Inc.1986-11-25
D100 COMPUTER CARDIAC ANALYSIS SYSTEM (K863231)Dextra Medical, Inc.1986-11-25
MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY (K864461)Medsurg Industries, Inc.1986-11-24
DAIG TYPE O4 VS-1 CONNECTOR (K863921)Daig Corp.1986-11-24
URESIL CAROTID SHUNT (K863558)Uresil Corp.1986-11-24
SPACELABS ARRHYTHMIA NET (TM) LEVEL 2 (K864505)Spacelabs, Inc.1986-11-24
LIFE-WATCH MONITOR LT-8 (K863534)Computerized Medical Systems, Inc.1986-11-21
PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE (K863366)Labeltape Meditect, Inc.1986-11-21
NELLCOR N-200 (PULSE OXIMETER) (K863784)Nellcor, Inc.1986-11-21
MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD (K864287)Intermedics, Inc.1986-11-20
MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (K864155)American Edwards Laboratories1986-11-20
630C ELECTROCARDIOGRAPH (K863030)Quinton, Inc.1986-11-20
MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD (K864002)Intermedics, Inc.1986-11-20
EM III DISPOSABLE ELECTRODE (K863845)Electromed Intl., Ltd.1986-11-20
CHIN-FOGARTY INFLATION DEVICE (K863596)American Edwards Laboratories1986-11-20
MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM (K863724)Oxford Medilog, Inc.1986-11-20
CLAMPEASE FA (K863427)Freund Medical Products1986-11-20
TERUMO RADIFOCUS GUIDE WIRE (K863138)Terumo Medical Corp.1986-11-20
CASE 12 (K862316)Marquette Electronics, Inc.1986-11-20
MODEL (MB-700) BLOOD PRESSURE MONITOR (K863672)Sharp Electronics Corp.1986-11-18
MODIFIED SARNS OXYGENATOR SYSTEM (K863515)3M Health Care, Sarns1986-11-18
FORTEC MI-100, BLOOD PRESSURE METER (K862200)Fortec Electronic Corp./Nam Tai1986-11-18
SARNS SAFETY LOOP (K863593)3M Health Care, Sarns1986-11-18
STOCKERT-SHILEY CAPS HLM INTERFACE (K863541)Shiley, Inc.1986-11-18
BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM) (K862714)Electro-Diagnostic Instruments1986-11-17
DOPPLEX, PULSED/CONTINUOUS WAVE DOPPOLER (K861023)Diagnostic Electronics Corp.1986-11-17
NORELCO ELECTRONIC DIGITAL BP METER HC3030 (K854279)Philips Park1986-11-17
VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES (K862720)Sonicaid, Inc.1986-11-17
NORELCO DIGITAL BLOOD PRESSURE METER HC3001 (K855048)Philips Park1986-11-17
K-STIK DEFIBRILLATION PADS (K863899)Katecho, Inc.1986-11-12
CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON (K852547)Cortronic Corp.1986-11-10
HIGH VELOCITY CW DOPPLER SYSTEM (K862841)Biosound, Inc.1986-11-10
BIOCHEM CO/OX 1000 (K863186)Biochem International, Inc.1986-11-07
ECG MODULE (K862553)Elscint, Inc.1986-11-07
DECITEL AUSCULSCOPE (K860994)Bloomfield Research and Development, Inc.1986-11-07
NORELCO ELECTRNIC DIGITAL BLOOD PRESSURE METER (K855177)Philips Park1986-11-07
SERIES 7200 TRANSPORT/REMOTE ACQUISITION MONITOR (K860734)Marquette Electronics, Inc.1986-11-06
CARDIOSCAN WITH DOPPLER OPTION (K862913)Interspec, Inc.1986-11-04
SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES (K863372)Interspec, Inc.1986-11-04
MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD (K863781)Intermedics, Inc.1986-11-03
CORDIS CONTRAST INJECTION LINES (K864141)Cordis Corp.1986-11-03
MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER (K864048)Intermedics, Inc.1986-11-03
WALRUS: DOUBLE BALLOON SHUNTING CATHETER (K862190)Medical Parameters, Inc.1986-11-03
MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER (K864047)Intermedics, Inc.1986-11-03
QUINTON Q.CATH (K862740)Quinton, Inc.1986-10-31
MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMB (K863581)The Kendal Co.1986-10-31
CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY (K863537)Cordis Corp.1986-10-31
LUER LOCK SKIRT (K862451)Hewlett-Packard Co.1986-10-31
CARDIOLIFE TEC 7200 (K863405)Nihon Kohden America, Inc.1986-10-31
MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE (K863547)Medtronic Vascular1986-10-31
TDMAC-HEPARIN COATED RMI CAROTID BY-PASS SHUNT (K862634)Research Medical, Inc.1986-10-31
3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) (K862966)Oscor Medical Corp.1986-10-31
CARDIOLIFE TEC 7100 (K863404)Nihon Kohden America, Inc.1986-10-31
MEDI-PLAST DISPOSABLE MANIFOLD (K863402)Medi-Plast Intl., Inc.1986-10-22
OXYGENATOR MODEL NO. BENTLEY-10 PLUS (K863249)American Bentley1986-10-20
VERSAFLEX(TM) DELTA ST(TM) MONITOR (K863922)Versaflex Delivery Systems, Inc.1986-10-20
PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART (K860646)Analogic Corp.1986-10-16
CORDIS ANGIOPLASTY HEMOSTASIS DEVICES (K863177)Cordis Corp.1986-10-15
CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE) (K863863)Cardionostics, Inc.1986-10-15
TERUMO RADIFOCUS INTRODUCER KIT (K863139)Terumo Medical Corp.1986-10-10
URESIL IRRIGATION CATHETER (K863564)Uresil Corp.1986-10-10
URESIL OCCLUSION BALLOON CATHETER (K863559)Uresil Corp.1986-10-10
TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER (K863137)Terumo Medical Corp.1986-10-10
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