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Cardiovascular

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

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RecordFirmDate
VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS (K060142)Vascutek, Ltd.2006-02-07
LYSUS INFUSION SYSTEM (K060084)Ekos Corp.2006-02-07
DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P) (K051217)GE Healthcare2006-02-03
HOCA EZ-CARE BP108, TENDER-CARE BP109 (K052671)Hoca Medical Microsystem, Inc.2006-02-03
ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II (K053006)Rossmax Internationl , Ltd.2006-02-03
LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM (K052446)Hoana Medical, Inc.2006-02-02
TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS) (K052608)Bl Healthcare, Inc.2006-02-01
LUCAS (K053403)Jolife AB2006-02-01
BIOSIGN (K053112)Oxford Biosignals Limited2006-01-31
GALIX ECG PROFESSIONAL STATION (K051163)Galix Biomedical Instrumentation, Inc.2006-01-31
FIBERED IDC OCCLUSION SYSTEM (K060078)Boston Scientific Corporation2006-01-31
ESTECH CLEARVIEW MV ATRIAL DEPRESSOR (K053021)Estech, Inc.2006-01-26
LEVITRONIX CENTRIMAG PRIMARY CONSOLE (K053630)Levitronix, LLC2006-01-26
PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM (K053185)Medwave, Inc.2006-01-24
DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE (K052975)GE Healthcare2006-01-20
LIFENET EXCHANGE SYSTEM (K052854)Medtronic Emergency Response Systems, Inc.2006-01-20
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS (K051400)GE Healthcare2006-01-20
STELLAR 404T (K060058)Larsen & Toubro Limited2006-01-20
VASCON NEUROPATH GUIDING CATHETER (K052004)Vascon, LLC2006-01-19
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN (K052575)St Jude Medical2006-01-19
MERIT IMPRESS DIAGNOSTIC CATHETER (K053171)Merit Medical Systems, Inc.2006-01-19
3160 MRI PATIENT MONITORING SYSTEM (K053462)Invivo Corporation2006-01-18
CRITIVIEW (K051145)Critisense , Ltd.2006-01-18
SUPER SHEATH INTRODUCER SHEATH (K052557)Togo Medikit Co., Ltd.2006-01-17
SUTURING WASHER (K052642)First Call, Inc.2006-01-17
TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 (K052570)Cardiacassist, Inc.2006-01-17
DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES (K052976)GE Healthcare2006-01-13
MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, (K053460)Fox Hollow Technologies2006-01-13
CARDIOSOFT PC ECG, USB VERSION (K052295)Cardiosoft, L.P.2006-01-13
SIMPLICI-T ANNULOPLASTY SYSTEM (K052970)Medtronic Heart Valves2006-01-11
6248VAL ADJUSTABLE VALVE (K052459)Medtronic Vascular2006-01-11
ONYX II FINGER PULSE OXIMETER, MODEL 9550 (K053130)Nonin Medical, Inc.2006-01-11
OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR (K051271)Nellcor Puritan Bennett, Inc.2006-01-10
PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00 (K053522)Philips Medizin Systeme Boeblingen GmbH2006-01-10
CG-7000DX-BT ECG RECORDER/TRANSMITTER (K052556)Card Guard Scientific Survival , Ltd.2006-01-09
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN (K052964)Boston Scientific Corp2006-01-06
THE FINGER GUARD (K052619)T F & G Products2006-01-06
EKOS MICRO-INFUSION SYSTEM (K053437)Ekos Corp.2006-01-06
KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR (K051847)Kodon(Tianjin)Electronic&Electrical Apparatus Co.,2006-01-05
TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM (K053209)Suntech Medical, Inc.2006-01-05
ECHELON MICRO CATHETER (K051990)Micro Therapeutics, Inc.2006-01-04
RIO ASPIRATION CATHETER (K051880)Boston Scientific Corp2006-01-04
POWERHEART ECD (K052316)Cardiac Science, Inc.2006-01-03
TESLAGUARD, MODEL EFT G04 (K052119)Mammendorfer Institute For Physics & Medicine GmbH2006-01-03
CARDIOCOM COMMANDER III (K053303)Cardiocom, LLC2005-12-30
AMPLATZER SIZING BALLOON II (K053440)Aga Medical Corp.2005-12-30
COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM (K053304)Cardiocom, LLC2005-12-30
WIRELESS PHYSIOLOGIC MONITORING SYSTEM (K053016)Edwards Lifesciences, LLC2005-12-30
EKOS MICRO-INFUSION SYSTEM (K053432)Ekos Corp.2005-12-30
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 (K052972)GE Healthcare2005-12-29
FETALGARD LITE-NIBP, MODEL FGL-NIBP (K051903)Analogic Corporation2005-12-27
AQ-830 SLIM BODY, BODY FAT MONITOR (K052678)Limax Electronics Co., Ltd.2005-12-27
HEART STG SYSTEM AND SOFTWARE (K052283)Stethographics, Inc.2005-12-23
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100 (K052669)Nonin Medical, Inc.2005-12-23
BP PRO BLOOD PRESSURE MONITOR (K053395)Card Guard Scientific Survival , Ltd.2005-12-23
HOSPIRA CATH LAB CONVENIENCE KITS (K052865)Icu Medical, Inc.2005-12-22
LIFEPAK, MODEL 1000 (K042404)Medtronic Emergency Response Systems, Inc.2005-12-22
MEDILOG DARWIN HOLTER ANALYSIS (K053369)Huntleigh Healthcare2005-12-22
ADULT CEREBRAL OXIMETER, MODEL 2040 (K051257)Cas Medical Systems, Inc.2005-12-22
MASIMO SET RAD-8 PULSE OXIMETER (K053269)Masimo Corporation2005-12-21
VITALOGIK (K052288)Mennen Medical , Ltd.2005-12-20
REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA (K052081)Estech, Inc.2005-12-16
BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 (K052646)Biospace Corporation Limited2005-12-16
C2000 AUTOMATED MANIFOLD KIT (K052744)Acist Medical Systems, Inc.2005-12-16
STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX (K053118)Boston Scientific Corp2005-12-16
STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX (K053116)Boston Scientific Corp2005-12-16
READMYHEART, MODEL RMH2.0 (K052303)Dailycare Biomedical, Inc.2005-12-16
ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.) (K052160)Welch Allyn, Inc.2005-12-16
MODEL 750E SERIES MONITOR (K051896)Cas Medical Systems, Inc.2005-12-16
ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 (K052727)Rossmax International , Ltd.2005-12-16
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 (K053011)Bio Protech, Inc.2005-12-14
STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2 (K052522)Stayhealthy, Inc.2005-12-13
VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER (K052258)Vascular Solutions, Inc.2005-12-13
CRONUS GUIDEWIRE, MODEL 001-001470-1 (K051373)Stereotaxis, Inc.2005-12-09
RESOLUTION ENDOVASCULAR SYSTEM (K052428)Omnisonics Medical Technologies2005-12-08
MIRA-FLEX 18 MICROCATHETER (K052841)Cook, Inc.2005-12-08
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (K051513)Bipore, Inc.2005-12-07
INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044 (K052738)Veinrx, Inc.2005-12-06
SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER (K052644)St Jude Medical2005-12-05
FOX PULSE OXIMETER (K051736)Shunsuke Nakanishi2005-12-02
ASAHI PTCA GUIDE WIRE (K052339)Asahi Intecc Co., Ltd.2005-11-30
DATRIX CARDIO WIFI ELECTROCARDIOGRAPH (K053083)Datrix2005-11-30
BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J (K052578)Bard Peripheral Vascular, Inc.2005-11-25
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER (K052257)Vascular Solutions, Inc.2005-11-23
MREYE EMBOLIZATION COIL (K052834)Cook, Inc.2005-11-23
IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A (K052872)Taidoc Technology Corporation2005-11-23
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT (K052524)Medtronic Perfusion Systems2005-11-22
DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900 (K052784)Welch Allyn, Inc.2005-11-22
DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES (K052977)GE Healthcare2005-11-22
VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) (K053027)Welch Allyn, Inc.2005-11-22
GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER (K052381)Zerusa Limited2005-11-21
MEDITECH MODEL ABPM-04 (K051149)Meditech Kft.2005-11-18
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN (K052961)Philips Medical Systems2005-11-18
PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. (K052377)Philips Medizin Systeme Boeblingen GmbH2005-11-17
ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC (K052899)Genesee Biomedical, Inc.2005-11-17
ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF (K052565)Genesee Biomedical, Inc.2005-11-17
INFINITY ALPHA (K051658)Draeger Medical Systems, Inc.2005-11-16
REPROCESSED ELECTROPHYSIOLOGY CATHETER (K052414)Alliance Medical Corp.2005-11-16
REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS (K052603)Alliance Medical Corp.2005-11-16
EXTENDED MEASUREMENTS SYSTEM (K051450)Inovise Medical, Inc.2005-11-10
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