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Cardiovascular

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

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RecordFirmDate
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS (K070951)Boston Scientific2007-06-04
INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL (K070566)Draeger Medical Systems, Inc.2007-06-04
GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610 (K070372)Vascular Solutions, Inc.2007-06-01
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM (K071358)Radiant Medical2007-06-01
SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES (K062149)International Business Strategies2007-05-31
CARDIOMEM CM 3000-12BT (K063042)Getemed Medizin- Und Informationstechnik AG2007-05-30
LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR (K070825)Little Doctor (Shanghai) Electronic Manufacturing2007-05-25
AUTO DETECT FOR TELAHEART DR200/E-A (K070014)North East Monitoring, Inc.2007-05-25
DURAMAX REUSABLE OXIMETRY SENSOR (K070408)Nellcor Puritan Bennett, Inc.2007-05-25
TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A (K071075)Terumo Corp.2007-05-25
RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 (K063661)Renu Medical, Inc.2007-05-25
OSTIAL PRO STENT POSITIONING SYSTEM (K062192)Ostial Solutions, LLC2007-05-24
MICRUS COURIER ENZO MICROCATHETER 0.017 (K070456)Micrus Endovascular Corporation2007-05-24
BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX (K070473)Zen Strong Medical Technology Co., Ltd.2007-05-23
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 (K070396)Acumen Medical, Inc.2007-05-22
WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS (K071040)Wright Linear Pump, Inc.2007-05-22
BIO-CONSOLE, MODEL 560 (K070286)Medtronic2007-05-22
ASPIRA PLEURAL DRAINAGE SYSTEM (K071095)Bard Access Systems, Inc.2007-05-18
EDAC QUANTIFIER (K071231)Luna Innovations, Inc.2007-05-17
CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER (K071189)Cordis Europa, N.V.2007-05-16
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 (K070242)Biosense Webster, Inc.2007-05-15
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (K071073)Ge Medical Systems Information Technologies2007-05-11
MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 (K063638)St Jude Medical2007-05-11
FETCH ASPIRATION CATHETER (K070363)Possis Medical, Inc.2007-05-11
ACCUPULSE PULSE OXIMETER (K062724)Eagle Medical Equipment Co.2007-05-11
SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR (K070086)Sensacare , Ltd.2007-05-10
COLIN PRESS MATE, MODEL BP S510 (K063690)Omron Healthcare, Inc.2007-05-09
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM (K071008)Radiant Medical2007-05-09
LIFESENSE, MODEL LS1-9R (K063752)Nonin Medical, Inc.2007-05-04
CORSCREEN (K070614)Viasys Healthcare GmbH2007-05-04
CARTO XP EP NAVIGATION SYSTEM, VERSION 9 (K070240)Biosense Webster, Inc.2007-05-04
IPC-BOOT (K070324)C-Boot , Ltd.2007-05-03
247 BP DEVICE (K070750)Suntech Medical, Inc.2007-05-02
ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES (K070193)Envitec-Wismar GmbH2007-05-02
HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH (K052480)Hansen Medical, Inc.2007-05-02
PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000 (K063137)Pharmasmart, Inc.2007-05-01
MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000 (K070902)St Jude Medical2007-05-01
PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A (K063783)Philips Medical Systems, Inc.2007-04-27
OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION (K063503)Mallinckrodt Inc., Liebel-Flarsheim Business2007-04-27
RUNTHROUGH NS (K063695)Terumo Medical Corp.2007-04-27
COOK MICROWIRE WIRE GUIDE (K070410)Cook, Inc.2007-04-27
MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER (K071011)Braemar, Inc.2007-04-27
ZOLL E SERIES WITH SEE-THRU CPR (K070455)Zoll Medical Corporation, World Wide Headquarters2007-04-26
MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR (K070839)Terumo Cardiovascular Systems Corp.2007-04-24
MODIFIED MERCY RETRIEVER, MODEL 90070 (K070521)Concentric Medical, Inc.2007-04-24
COOK CELECT VENA CAVA FILTER (K061815)William Cook Europe Aps2007-04-20
HORIZON SE (K070254)Mennen Medical , Ltd.2007-04-19
ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM (K070710)Biosensors International-USA2007-04-19
DYE MANAGEMENT SYSTEM (K063784)Icu Medical, Inc.2007-04-16
AUDICOR 200 SYSTEM, MODELS 200D AND 200S (K070136)Inovise Medical, Inc.2007-04-13
EMPOWERMR INJECTOR SYSTEM, MODEL 9730 (K062449)E-Z-Em, Inc.2007-04-13
MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N (K061896)Mediaid, Inc.2007-04-12
HYPERVISOR VI CENTRAL MONITORING SYSTEM (K062194)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2007-04-11
EP-WORKMATE (K070706)Ep Medsystems2007-04-11
STRADA CAROTID GUIDING SHEATH (K070166)St Jude Medical2007-04-06
ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM (K070051)Acumen Medical, Inc.2007-04-06
MEDILOGAR4, MEDILOGAR12 (K070818)Tom Medical Entwicklungs GmbH2007-04-06
HYPERQ SYSTEM (K070624)Biological Signal Processing, Ltd.2007-04-06
CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 (K070680)Cardiomems, Inc.2007-04-05
IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS (K050415)Impedimed Pty , Ltd.2007-03-30
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER (K063076)Ascent Healthcare Solutions2007-03-29
ARGON CONTINUOUS FLUSH DEVICE (K070384)Argon Medical Devices, Inc.2007-03-29
TR BAND (K070423)Terumo Medical Corp.2007-03-28
MODIFICATION TO HEALTH BUDDY APPLIANCE (K070543)Health Hero Network, Inc.2007-03-28
ECG CABLES, TRUNK AND PATIENT LEAD WIRES (K070232)American I.V. Products, Inc.2007-03-27
MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY (K063090)Medrad, Inc.2007-03-27
MOORLD12-B1 LASER DOPPLER BURNS IMAGER (K060976)Moor Instruments, Ltd.2007-03-27
BP 101 DIGITAL BLOOD PRESSURE MONITOR (K062033)Kingyield Hongkong Limited2007-03-23
LINK TO ACUITY CLINICIAN NOTIFIER (K070204)Welch Allyn Protocol, Inc.2007-03-23
CARDIOBELT ELECTRODE BELT (K063044)Monebo Technologies, Inc.2007-03-23
MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0 (K062282)Monebo Technologies, Inc.2007-03-22
BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L (K070485)Cardiva Medical, Inc.2007-03-22
PERFORMER CBP SYSTEM (K070213)Rand S.R.L.2007-03-21
PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER) (K070588)Philips Medical Systems2007-03-20
ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER (K063863)Advantage Medical Cables, Inc.2007-03-20
IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER (K070011)Irvine Biomedical,Inc.(Ibi)2007-03-20
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX (K070487)Volcano Corporation2007-03-16
MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER (K062976)Ge Medical Systems Information Technologies2007-03-16
SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 (K063490)Spacelabs Medical, Inc.2007-03-15
REPROCESSED HEART STABILIZERS AND POSITIONERS (K063844)Sterilmed, Inc.2007-03-15
ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488 (K063210)Medtronic Inc. Cardiac Rhythm Management2007-03-15
CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 (K070448)Cardiomems, Inc.2007-03-15
MORTARA ELI 10 ELECTROCARDIOGRAPH (K070539)Mortara Instrument, Inc.2007-03-15
MODIFICATION TO HYPERTRANSIT INFUSION CATHETER (K070279)Cordis Neurovascular, Inc.2007-03-14
TENDERFLOW PERIATRIC ARTERIAL CANNULA (K063618)Terumo Cardiovascular Systems Corp.2007-03-13
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02 (K070421)GE Healthcare2007-03-13
BP-200 PLUS (K063814)Schiller AG2007-03-07
CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER (K063563)Cordis Europa, N.V.2007-03-07
CADWELL EASYNET OXIMETER MODULE (K061706)Cadwell Laboratories, Inc.2007-03-05
AMPLATZER RELIANT CATHETER DELIVERY SYSTEM (K070238)Aga Medical Corp.2007-02-28
D-STAT HANDLE, MODEL 8500-053 (K063871)Vascular Solutions, Inc.2007-02-28
ZOLL M SERIES WITH REAL CPR HELP (K062537)ZOLL Medical Corporation2007-02-28
CRITIVIEW, MODEL CRV3 (K062977)Critisense , Ltd.2007-02-28
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0 (K070260)Philips Medical Systems2007-02-23
BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 (K062852)Onset Medical Corporation2007-02-23
ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY (K070197)Acumen Medical, Inc.2007-02-23
CARDIODAY, VERSION 2.0 (K070280)Getemed Medizin- Und Informationstechnik AG2007-02-23
CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR (K063349)Cormatrix Cardiovascular, Inc.2007-02-16
INFINITY TELESMART TELEMETRY SYSTEM (K061379)Draeger Medical Systems, Inc.2007-02-16
TEMPORARY LIMB SALVAGE SHUNT (K070323)Vascutek, Ltd.2007-02-15
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