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Cardiovascular

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

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RecordFirmDate
VITAL SIGNS MONITOR (K051375)Mediana Co., Ltd.2005-07-28
BIB PTA BALLOON CATHETER (K050857)NuMED, Inc.2005-07-28
MINI GHOST PTA CATHETER, MODEL 507 (K051343)NuMED, Inc.2005-07-28
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100 (K051790)3M Company2005-07-25
INFINITY MONITORS WITH SCIO MODIFICATIONS (K051628)Draeger Medical Systems, Inc.2005-07-20
MARS HOLTER ANALYSIS WORKSTATION (K051026)Ge Medical Systems Information Technologies2005-07-19
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION (K051634)GE Healthcare2005-07-19
MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370 (K050951)Cibernet Systems Corp.2005-07-19
VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO (K051062)Flowcardia, Inc.2005-07-15
LNOP BLUE OXIMETRY SENSOR (K051439)Masimo Corporation2005-07-15
READMYHEART, MODEL RMH3.0 (K050620)Dailycare Biomedical, Inc.2005-07-14
ILAB ULTRASOUND IMAGING SYSTEM (K051679)Boston Scientific Corp2005-07-14
CARDIOMEM CM 3000-12 (K051686)Getemed Medizin- Und Informationstechnik AG2005-07-14
IMPEDIMED - BODY COMPOSITION ANALYSIS (K050395)Impedimed Pty , Ltd.2005-07-13
MODIFICATION TO LNCS OXIMETRY SENSORS (K051212)Masimo Corporation2005-07-12
UNITY NETWORK ID (K051518)Ge Medical Systems Information Technologies2005-07-08
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS (K051106)Philips Medizin Systeme Boeblingen GmbH2005-07-01
TESLAOXYSAT, MODEL EFOXYSATE (K050018)Mammendorfer Institute For Physics & Medicine GmbH2005-07-01
PMP4 MEDICAL WEB CENTER (K050940)Card Guard Scientific Survival , Ltd.2005-07-01
STAR 50 MONITORING SYSTEM (K051608)Larsen & Toubro Limited2005-06-29
CARDIODAY (K051471)Getemed Medizin- Und Informationstechnik AG2005-06-29
ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM (K050858)Heartlab, Inc.2005-06-29
DATEX-OHMEDA OXY-AFR SENSOR (K042891)Datex-Ohmeda2005-06-29
ZOLL M SERIES 12SL ANALYSIS OPTION (K051475)ZOLL Medical Corporation2005-06-24
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER (K051395)Vascular Solutions, Inc.2005-06-24
BPCALIBRATOR MC3000/MC3100 (K051546)Healthstats International Pte. , Ltd.2005-06-24
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR (K050877)Biosense Webster, Inc.2005-06-24
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE (K051283)Cardiopulmonary Corp.2005-06-23
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (K051374)Stereotaxis, Inc.2005-06-23
750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL (K050844)Cas Medical Systems, Inc.2005-06-23
PERIPHERAL CUTTING BALLOON (K051254)Boston Scientific Ivt2005-06-22
MODEL 2500A PALMSAT PULSE OXIMETER (K050056)Nonin Medical, Inc.2005-06-21
FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) (K051519)Abbott Laboratories (Perclose, Inc.)2005-06-21
REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER (K050995)Volcano Corporation2005-06-20
ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A (K051021)Shanghai Lord International Trade Co., Ltd.2005-06-20
PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000 (K051367)Ge Medical Systems Information Technologies2005-06-20
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM (K050456)Medrad, Inc.2005-06-17
LYSUS INFUSION SYSTEM (K051319)Ekos Corp.2005-06-15
LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P (K050919)Analogic Corp.2005-06-14
REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K051220)Sterilmed, Inc.2005-06-14
DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE (K051084)Denver Biomedicals, Inc.2005-06-13
PV 1900 SYNCHRO 0.016 GUIDEWIRE (K050964)Boston Scientific - Precision Vascular2005-06-13
BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG (K051228)Cardiodynamics International Corp.2005-06-10
BIO-CONSOLE, MODEL 560 (K051303)Medtronic Perfusion Systems2005-06-10
EKOS MICRO-INFUSION SYSTEM (K051225)Ekos Corp.2005-06-10
REMOTE CARE MANAGEMENT SYSTEMS (RCMS) (K051470)Bl Healthcare, Inc.2005-06-08
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL] (K050916)Intra Luminal Therapeutics, Inc.2005-06-08
EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 (K051179)Boston Scientific Corp2005-06-08
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] (K050915)Intra Luminal Therapeutics, Inc.2005-06-07
MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER (K050371)Medrad, Inc.2005-06-07
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K051043)Vanguard Medical Concepts, Inc.2005-06-06
TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER (K050599)Boston Scientific Corp2005-06-03
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K050763)Vanguard Medical Concepts, Inc.2005-06-01
ONYX II FINGER PULSE OXIMETER, MODEL 9550 (K051107)Nonin Medical, Inc.2005-06-01
BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO (K050006)C.R. Bard, Inc.2005-05-27
PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) (K051067)LeMaitre Vascular, Inc.2005-05-27
VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY (K050146)Vascular Solutions, Inc.2005-05-27
CANALIZER HYDROPHILIC GUIDE WIRE (K050873)Medical Device Technologies, Inc.2005-05-26
ANGIODYNAMICS PROFILER PTA BALLOON CATHETER (K051060)AngioDynamics, Inc.2005-05-26
ULTRA-SOFT SV BALLOON DILATATION CATHETER (K050389)Boston Scientific Corp2005-05-25
ELECTRODE (K050248)Electramold2005-05-25
D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER (K051232)Dideco S.R.L.2005-05-20
THE HERMES SYSTEM (K050929)Palaistra Systems, Inc.2005-05-20
ATLANTIS PV (K050684)Boston Scientific Corp2005-05-20
SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM (K050731)Ge Medical Systems Information Technologies2005-05-19
ENPATH DEFLECTABLE CATHETER (K043489)Enpath Medical Incorporated2005-05-19
ADAPTER CABLE (K050884)Remington Medical, Inc.2005-05-19
CARDIOSCOPE SONOPLUS 3000 (K051126)Pulsonic Ag, Medical Technology2005-05-19
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER (K050168)Vascular Solutions, Inc.2005-05-18
APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582 (K051096)St. Jude Medical, Daig Division, Inc.2005-05-17
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM (K050093)Ge Medical Systems Information Technologies2005-05-13
KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM (K050130)Kerberos Proximal Solutions, Inc.2005-05-13
VITALWARE VMS (K050128)Televital, Inc.2005-05-13
BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7 (K050680)OSTAR MEDITECH CORP.2005-05-13
ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES (K051076)ZOLL Medical Corporation2005-05-13
AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS (K050252)Masimo Corporation2005-05-11
TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060 (K050926)Idev Technologies, Inc.2005-05-09
MERIT PRELUDE SHEATH INTRODUCER (K050962)Merit Medical Systems, Inc.2005-05-06
CONCENTRIC EMBOLIC PEARLS (K050470)Concentric Medical, Inc.2005-05-06
ECC.O SYSTEM (K050890)Dideco S.R.L.2005-05-05
SKIPPER AND SKIPPER RACE GUIDEWIRE (K050756)Invatec Innovative Technologies, S.R.L.2005-05-05
GUNTHER TULIP VENA CAVA FILTER SET (K043509)Cook, Inc.2005-05-05
WINDSURFER (K050561)Medcon , Ltd.2005-05-04
CARDIOVIT AT-10PLUS (K050686)Schiller AG2005-05-04
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 (K050605)Spacelabs Medical, Inc.2005-05-03
PREMERE DELIVERY SHEATH, MODEL PDS (K043084)Velocimed, Inc.2005-05-02
DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS (K050974)Draeger Medical Systems, Inc.2005-04-29
LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE (K043604)Vivometrics, Inc.2005-04-29
ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER (K050794)Possis Medical, Inc.2005-04-28
EKOS ULTRASOUND INFUSION SYSTEM (K041826)Ekos Corp.2005-04-27
MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1 (K043380)Monebo Technologies, Inc.2005-04-26
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 (K050762)Philips Medizin Systeme Boeblingen GmbH2005-04-22
MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 (K043531)K-Jump Health Co., Ltd.2005-04-21
DOLPHIN INFLATION DEVICE (K042449)Sedat S.A.2005-04-18
HYPERTRANSIT INFUSION CATHETER (K043538)Cordis Neurovascular, Inc.2005-04-18
SMARTDOP 45 VASCULAR DOPPLER (K050601)Koven Technology, Inc.2005-04-15
TELEREHAD 2004 (K050778)Scottcare2005-04-13
RELIANT STENT GRAFT BALLOON CATHETER (K050038)Medtronic Endovascular Innovations2005-04-13
BLOOD-PRESSURE METER, BPW120 (K050083)Idt Technology Limited2005-04-08
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT (K050711)Health & Life Co., Ltd.2005-04-07
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