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Cardiovascular

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

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RecordFirmDate
SOLAR 7/8000 (K993757)General Electric Medical Systems Information Techn2000-03-23
CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800 (K992703)Premier Heart, LLC2000-03-21
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM (K000635)Agilent Technologies, Inc.2000-03-20
IN-LINE HEMOSTASIS VALVE (K990975)Merit Medical Systems, Inc.2000-03-15
BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT (K994242)Bodystat , Ltd.2000-03-15
THE HOMMED SENTRY, MODEL 1 SENTRY (K993938)Hommed, LLC2000-03-15
MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502 (K000675)Jawon Medical Co., Ltd.2000-03-14
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 (K994157)Datascope Corp.2000-03-13
CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH (K992912)Cardiac Pathways Corp.2000-03-08
LEMAITRE IRRIGATION CATHETER (K992933)Vascutech, Inc.2000-03-08
ALLON 2000 (K992386)Mtre Advanced Technology , Ltd.2000-03-07
Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) (K992908)Quinton, Inc.2000-03-06
MIKRO-TIP ANGIOGRAPHIC CATHETER (K993694)Millar Instruments, Inc.2000-03-01
ADVANTA SUPER SOFT GRAFT (K000499)Atrium Medical Corp.2000-03-01
ADVANTA SUPER SOFT GRAFT (K000504)Atrium Medical Corp.2000-03-01
PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES (K992524)Advantage Medical Electronics, Inc.2000-03-01
MPT 24 AND VITAL VIEW 24 (K000276)Criticare Systems, Inc.2000-03-01
CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001 (K991684)Thermogear, Inc.2000-03-01
MODIFIED HYDROPHILIC COATED GUIDEWIRE (K000011)Lake Region Mfg., Inc.2000-03-01
LEMAITRE VENOUS THROMBECTOMY CATHETER (K992934)Vascutech, Inc.2000-03-01
CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING (K993189)Terumo Corp.2000-03-01
MODIFICATION TO T-REX BIOPSY FORCEPS (K000409)Boston Scientific Corp2000-02-28
ZOLL M SERIES ETCO2 OPTION (K993036)Zoll Medical Corp2000-02-28
CLEEN-ABLE (K994044)Vital Signs, Inc.2000-02-25
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511 (K000430)Medtronic Vascular2000-02-25
VERIPATH PERIPHERAL GUIDING CATHETER (K994229)Advanced Cardiovascular Systems, Inc.2000-02-25
DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 (K992638)Critikon Company, LLC2000-02-24
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT (K000210)Medtronic Vascular2000-02-23
MARSPO2, MODEL 2001 (K993979)Novametrix Medical Systems, Inc.2000-02-22
SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR (K993974)Siemens Medical Solutions USA, Inc.2000-02-22
LEMAITRE BALLOON CATHETER WITH IRRIGATION (K992940)Vascutech, Inc.2000-02-22
IBC VRV, MODEL 1350 (K992657)International Biophysics Corp.2000-02-18
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER (K993966)Arrow Intl., Inc.2000-02-18
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR (K991737)Dideco S.P.A.2000-02-17
SJM TAILOR ANNULOPLASTY RING, MODEL TARN (K000119)St. Jude Medical, Inc.2000-02-17
MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352 (K000379)Medtronic Vascular2000-02-16
ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION (K981936)Advanced Biomedical Devices, Inc.2000-02-16
KODAK HOME HEALTH MONITORING SYSTEM (K983928)Eastman Kodak Company2000-02-11
CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306 (K000225)Card Guard Scientific Survival , Ltd.2000-02-11
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE (K000274)Medtronic Cardiac Surgical Products2000-02-10
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER (K000101)Guidant Corp.2000-02-10
ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE (K993818)California Medical Laboratories, Inc.2000-02-08
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B (K993383)Hewlett-Packard GmbH2000-02-03
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 (K993745)Katecho, Inc.2000-02-03
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B (K992273)Hewlett-Packard GmbH2000-01-28
SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS (K993667)Sulzermedica2000-01-28
RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER (K993639)Guidant Corp.2000-01-27
POWERHEART AECD (K993533)Cardiac Science, Inc.2000-01-24
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR (K994331)Medtronic Vascular2000-01-21
WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK (K991545)Industrielle Entwicklung Medizintechnik Und Vertri2000-01-19
MULTIFUNCTION KEITO K5 (K984083)Bumedco Intl., Inc.2000-01-18
ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841 (K992749)Spacelabs Medical, Inc.2000-01-14
IBC FLOGUARD, MODEL 6050 (K992785)International Biophysics Corp.2000-01-14
VENAFLOW SYSTEM, MODEL 30A (K992454)Aircast, Inc.2000-01-13
PE 501 PC-ECG MONITOR (K992584)Nhe Corp.2000-01-13
PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX (K993531)Datascope Corp.2000-01-13
ATW MARKER WIRE STEERABLE GUIDEWIRE (K994358)Cordis Corp.2000-01-13
AESCULAP VASCULAR INSTRUMENTS (K992053)Aesculap, Inc.2000-01-13
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354 (K994208)Medtronic Perfusion Systems2000-01-13
AVIVA SYSTEM, MODEL SL1010 (K993550)American Telecare, Inc.2000-01-13
FLIPPER DETACHABLE EMBOLIZATION COIL (K993455)Cook, Inc.2000-01-11
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43 (K993460)Rossmax International , Ltd.2000-01-11
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44 (K993426)Rossmax International , Ltd.2000-01-07
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40 (K993429)Rossmax International , Ltd.2000-01-07
NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES (K992455)Nihon Kohden America, Inc.2000-01-07
BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP (K983866)Belmont Instrument Corp.2000-01-06
ENSTYLET MODELS EC0010, EC0020 (K993376)Endocardial Solutions, Inc.2000-01-05
TFX MEDICAL INTRODUCER KIT (K991647)Tfx Medical Group2000-01-04
REBAR MICRO CATHETER, MODELS 105-5080, 105-5086 (K993672)Micro Therapeutics, Inc.2000-01-04
INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE (K994252)Boston Scientific Corp2000-01-04
SULZER CARBOMEDICS CARDIOFIX PERICARDIUM (K993288)Sulzer Carbomedics, Inc.1999-12-29
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46 (K993542)Rossmax International , Ltd.1999-12-29
A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44 (K991541)A-Med Systems, Inc.1999-12-28
NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100 (K993643)Nexan Telemed , Ltd.1999-12-28
SPO2 WRAP SENSOR (K992211)Epic Medical Equipment Services, Inc.1999-12-22
STAT-SHELL DISPOSABLE SPO2 SENSOR (K992092)Epic Medical Equipment Services, Inc.1999-12-22
CG-2100 ECG TRANSMITTER (K994009)Card Guard Scientific Survival , Ltd.1999-12-21
PATHFINDER II ANGIOGRAPHIC CATHETER (K990173)Maxxim Medical1999-12-21
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A (K993169)Hewlett-Packard Co.1999-12-20
EMBOLIZATION COIL SYSTEM (K992121)Cook, Inc.1999-12-20
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46 (K993432)Rossmax International , Ltd.1999-12-20
INTERFACE MODULE IDDD (K992635)Stoeckert Instrumente1999-12-20
A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS (K993888)A&D Engineering, Inc.1999-12-20
YP 45/15-BP; YP 53/15-BP; YP 60/15-BP (K993139)Biotronik, Inc.1999-12-17
QMS MAPPING SYSTEM,MODEL 2000 (K990058)Cathdata, Inc.1999-12-15
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER (K992631)Acuson Corp.1999-12-15
INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR (K983250)Magnetic Resonance Equipment Corp.1999-12-12
CG-7000DX ECG RECORDER/TRANSMITTER (K993799)Card Guard Scientific Survival , Ltd.1999-12-10
CHEST DRAINAGE TUBING (K993062)Olson Medical Sales, Inc.1999-12-10
DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00 (K991714)Doctor'S Research Group, Inc.1999-12-10
LUMA-CATH STEERABLE EP CATHETERS (K991878)Irvine Biomedical, Inc.1999-12-10
3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE (K991756)Bio-Research Associates, Inc.1999-12-10
SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630) (K993072)Survivalink Corp.1999-12-10
SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS (K990503)Sulzermedica1999-12-09
LEMAITRE EMBOLECTOMY CATHETER (K992368)Vascutech, Inc.1999-12-09
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH (K992595)Hewlett-Packard GmbH1999-12-08
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH (K993774)Acist Medical Systems1999-12-07
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 (K990113)Maersk Medical A/S1999-12-06
DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 (K990115)Maersk Medical A/S1999-12-06
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 (K990111)Maersk Medical A/S1999-12-06
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