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Cardiovascular

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

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RecordFirmDate
WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20 (K031582)Nihon Seimitsu Sokki Co., Ltd.2003-08-01
MEDRAD MANUAL SYRINGE LOADER (K031483)Medrad, Inc.2003-08-01
CARDIODIRECT, MODELS 12M, 12I, 12S (K024283)Reynolds Medical , Ltd.2003-08-01
CARDIOSOFT/CASE CARDIAC TESTING SYSTEM (K031561)Ge Medical Systems Information Technologies2003-08-01
HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II (K012715)Hygia Health Services, Inc.2003-08-01
MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB (K030671)Medtronic Vascular2003-07-31
POWERHEART AED G3, MODEL 9300 (K031987)Cardiac Science2003-07-30
REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE (K031550)Vivometrics, Inc.2003-07-29
MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR (K030221)Mytech Technology Co., Ltd.2003-07-25
ELI 200+ AUDICOR (K031182)Mortara Instrument, Inc.2003-07-25
RECOVERY FILTER SYSTEM, MODEL RF-048F (K031328)C.R. Bard, Inc.2003-07-25
MC2X MULTI-STAGE VENOUS CANNULA (K031776)Medtronic Perfusion Systems2003-07-25
RAPIDO CUT-AWAY CUTTER (K031459)Guidant Corp.2003-07-23
PICOSAT II SPO2 PULSE OXIMETRY MODULE (K030973)Philips Medical Systems2003-07-23
MODEL 9600, AVANT PULSE OXIMETER (K023044)Nonin Medical, Inc.2003-07-23
PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A (K032103)Philips Medical Systems2003-07-22
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER (K031161)Biosense Webster, Inc.2003-07-22
EKOS PERIPHERAL INFUSION SYSTEM (K030637)Ekos Corp.2003-07-22
APEEL CS CATHETER DELIVERY SYSTEM (K031906)St Jude Medical2003-07-18
RADIUS 018 COUGAR WIRE (K032129)Radius Medical Technologies, Inc.2003-07-17
GALT MEDICAL GUIDEWIRE (K031916)Galt Medical Corp.2003-07-17
ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH (K031211)Medtronic Vascular2003-07-17
DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES (K031376)Ge Medical Systems Information Technologies2003-07-16
CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF (K031416)Clearmedical, Inc.2003-07-15
SAFETY INTRODUCER NEEDLE (K030135)B.Braun Medical, Inc.2003-07-15
KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS (K030788)Geister Medizin Technik GmbH2003-07-12
OPTIBOLUS (K031339)Mallinckrodt Inc., Liebel-Flarsheim Business2003-07-11
ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1 (K031417)Intra Luminal Therapeutics, Inc.2003-07-11
MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE (K030547)Guardian Angel Products, Inc.2003-07-11
BODY SIGNAL ECG ELECTRODE (K031174)Wandy Rubber Industrial Co., Ltd.2003-07-10
4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX (K030852)Mogul Enterprises2003-07-10
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR (K032040)Dideco S.P.A.2003-07-09
TELZUIT CARDIAC MONITORING SYSTEM (K031229)Telzuit Technologies, Inc.2003-07-09
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291 (K031422)Philips Medical Systems2003-07-03
RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE (K031688)Guidant Corporation2003-07-02
ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX (K031827)Medtronic Perfusion Systems2003-07-02
HL168R (K031695)Health & Life Co., Ltd.2003-07-01
HL888RA (K031835)Health & Life Co., Ltd.2003-07-01
CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 (K024323)Biomedical Systems Corp.2003-06-30
METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER (K024000)Angiometrx, Inc.2003-06-26
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER (K031766)Cook, Inc.2003-06-26
TS3 TUBING SET (K031151)Global Blood Resources, LLC2003-06-26
SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010 (K023817)Clio Designs, Inc.2003-06-25
RAPIDO CUT-AWAY GUIDING CATHETER (K031505)Guidant Corporation2003-06-25
DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES (K031781)Datex-Ohmeda2003-06-25
NITREX NITINOL GUIDEWIRE (K031864)Ev3 Corporation2003-06-24
HEMOBAG, MODEL HBBSD2000 (K031150)Global Blood Resources, LLC2003-06-23
PER, MODEL MEMO (K030218)Medical Monitors Pty., Ltd.2003-06-23
JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 (K031346)Jomed, Inc.2003-06-23
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL (K030944)Edwards Lifesciences, LLC2003-06-20
REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 (K024243)Fox Hollow Technologies2003-06-20
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 (K031571)E-Z-Em, Inc.2003-06-19
PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV (K031164)Oscor, Inc.2003-06-19
LUMEND FRONTRUNNER GW CTO CATHETER (K031005)Lumend, Inc.2003-06-18
ULTRA HIGH PRESSURE INJECTOR LINES (K023591)Deroyal Industries, Inc.2003-06-18
MODIFICATION TO IVS INTRODUCER SET, MODEL 1003 (K031583)Integrated Vascular Systems, Inc.2003-06-16
IQMARK DIGITAL HOLTER (K031466)Brentwood Medical Technology Corp.2003-06-11
EKGCARD SYSTEM (K030535)Qrs Diagnostic, LLC2003-06-11
GALIX PACESTAR (K023080)Galix Biomedical Instrumentation, Inc.2003-06-11
PRIME ECG SYSTEM (K030104)Meridian Medical Technologies, Inc.2003-06-11
DISPOSABLE TEMPORARY PACING WIRE (K023174)River Medical, Inc.2003-06-11
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX (K031569)Datascope Corp.2003-06-10
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM (K030738)Siemens Medical Solutions USA, Inc.2003-06-06
PRESSURE WIRE SENSOR, MODELS 12004/12304 (K031662)Radi Medical Systems AB2003-06-06
GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100 (K022926)Genteel Technology Co., Ltd.2003-06-06
AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506 (K031479)Datex-Ohmeda, Inc.2003-06-06
SHELHIGH BIORING (K023940)Shelhigh, Inc.2003-06-04
BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC (K023691)Boston Scientific Epi2003-06-04
ARTERIALFLOW SYSTEM, MODEL 32A (K024019)Aircast, Inc.2003-06-03
SIEMENS MICRO2+ WITH VAI SOFTWARE (K030640)Siemens Medical Solutions USA, Inc.2003-06-03
LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0 (K031000)C.R. Bard, Inc.2003-06-03
MAGLIFE C/MAGLIFE C PLUS (K023195)Schiller Medical S.A.2003-06-03
EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP (K030587)S-Tct Health, Inc.2003-05-30
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1 (K031403)Philips Medical Systems, Inc.2003-05-30
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING (K030726)Gish Biomedical, Inc.2003-05-30
CARECOMPANION PATIENT STATION & NURSE STATION (K022274)Neptec Design Group, Ltd.2003-05-29
PACEART SYSTEM (K024278)Medtronic Vascular2003-05-29
THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20 (K031481)Philips Medizin Systeme Boblingen GmbH2003-05-29
IN-VISION IMAGING SYSTEM (K031148)Jomed, Inc.2003-05-28
COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM (K023937)Cook Vascular, Inc.2003-05-27
REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K031610)Rex Medical2003-05-27
CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 (K030398)Cardiacassist, Inc.2003-05-23
OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N (K030930)Nellcor Puritan Bennett, Inc.2003-05-23
AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR) (K030230)Avita Corporation2003-05-23
EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX, (K031518)Medtronic Vascular2003-05-22
AVITA BF1 (VITALIO) BODY FAT ANALYZER (K020738)Avita Corporation2003-05-22
MODEL 5071 MYOCARDIAL PACING LEAD (K031274)Medtronic Vascular2003-05-22
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE (K030812)Datex-Ohmeda2003-05-21
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE (K030617)Boston Scientific Scimed, Inc.2003-05-21
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS (K030589)NuMED, Inc.2003-05-21
IS-1 HEMOSTASIS VALVE, MODEL 6799 (K031398)Guidant Corp.2003-05-20
DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421 (K030952)Dolphin Medical, Inc.2003-05-19
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (K031210)Metronic, Inc.2003-05-16
IBC FLOPUMP WITH GBS COATING (K031300)Gish Biomedical, Inc.2003-05-14
HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG (K030549)Guidcorp2003-05-14
JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 (K031277)Jomed, Inc.2003-05-14
CAPIOX CARDIOTOMY RESERVOIR (K030505)Terumo Cardiovascular Systems Corp.2003-05-14
DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000 (K022834)Ge Medical Systems Information Technologies2003-05-13
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE (K031037)Medtronic Perfusion Systems2003-05-13
INBODY AP1 BODY COMPOSITION ANALYZER (K023478)Biospace Co.,Ltd2003-05-13
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