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Cardiovascular

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

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RecordFirmDate
BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) (K022596)Clover Hi-Tech, Inc.2003-01-31
ANGIONEW-IV (K023701)Living Data Technologies Corporation2003-01-30
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE (K021340)External Counterpulsation Lab2003-01-30
ACIST GENTOO CONTRAST INJECTION SYSTEM (K020892)Acist Medical Systems2003-01-27
PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 (K022929)Cardiac Science, Inc.2003-01-27
ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. (K022360)Biotronik, Inc.2003-01-27
CELSIUS CONTROL SYSTEM (K022366)Innercool Therapies2003-01-27
FLOWLINE BIOPORE EPTFE VASCULAR GRAFT (K021547)Jotec GmbH2003-01-24
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM (K023878)Medtronic Vascular2003-01-24
NITREX NITINOL GUIDEWIRE (K024021)Ev3 Corporation2003-01-24
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE (K030019)Guidant Corp.2003-01-24
LUMEND FRONTRUNNER CTO CATHETER (K023114)Lumend, Inc.2003-01-23
RAPID THERMAL EXCHANGE SYSTEM (K023934)Avacore Technologies, Inc.2003-01-23
INNER-LOCK LOCKING INTRODUCER SHEATHS (K022170)Rex Medical2003-01-21
SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G (K023745)Sechrist Industries, Inc.2003-01-17
CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM (K023689)Card Guard Scientific Survival , Ltd.2003-01-17
SKINTACT (K024264)Leonhard Lang Co.2003-01-16
SKINTACT (K023920)Leonhard Lang GmbH2003-01-16
ENCLOSE ANASTOMOSIS ASSIST DEVICE (K023682)Novare Surgical Systems, Inc.2003-01-16
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR (K023356)Card Guard Scientific Survival , Ltd.2003-01-16
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL (K024247)Leonhard Lang GmbH2003-01-16
TM2005 PERSONAL MEDICAL PHONE CENTER (K024365)Card Guard Scientific Survival , Ltd.2003-01-15
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM (K021555)Stereotaxis, Inc.2003-01-15
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT (K024126)Abbott Laboratories2003-01-14
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 (K022145)LeMaitre Vascular, Inc.2003-01-14
PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR (K024156)Oscor, Inc.2003-01-14
HL888 (K023834)Health & Life Co., Ltd.2003-01-14
MEDRAD STELLANT CT INJECTOR SYSTEM (K023183)Medrad, Inc.2003-01-10
SOLA, COUNTER-PULSATION, MODEL SECP-S (K022078)Sola Medical Devices, LLC2003-01-10
NIKOMED TRACE 1 ECG ELECTRODES (K022909)Nikomed U.S.A., Inc.2003-01-09
LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 (K023960)Lidco, Ltd.2003-01-09
JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS (K020784)Jostra AG2003-01-09
CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM (K020863)Biosense Webster, Inc.2003-01-09
MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) (K022272)Medtronic Cardiac Surgical Products2003-01-08
ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106 (K024069)Medtronic Vascular2003-01-08
CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 (K021694)Cardiovention, Inc.2003-01-08
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 (K023427)Cardiomedics, Inc.2003-01-07
BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 (K023334)Baylis Medical Co., Inc.2002-12-31
ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY (K024032)Medtronic Vascular2002-12-30
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY (K024035)Medtronic Vascular2002-12-30
MODIFICATION TO CARDEON AEGIS CATHETER (K024058)Cardeon Corp.2002-12-30
FEMOSTOP FEMORAL COMPRESSION SYSTEM (K024107)Radi Medical Systems AB2002-12-24
HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089 (K021509)Hygia Health Services, Inc.2002-12-24
CHEETAH I.V.D.S., MODEL 2002P (K023370)Cheetah Medical, Inc.2002-12-24
VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02 (K023154)Vascular Control Systems, Inc.2002-12-20
BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 (K022660)Biocheck, Inc.2002-12-19
SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM (K024108)Siemens Medical Solutions USA, Inc.2002-12-18
JOSTRA MECC SYSTEM (K023132)Jostra AG2002-12-17
ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 (K023185)Sulzer Carbomedics, Inc.2002-12-17
PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 (K023112)Problem Solving Concepts, Inc.2002-12-17
JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 (K022762)Jomed, Inc.2002-12-16
MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 (K023938)Hutchinson Technology, Inc.2002-12-13
INFANT/CHILD REDUCED ENERGY ELECTRODES (K022732)Medtronic Physio-Control Corp.2002-12-13
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC (K021682)Omron Healthcare, Inc.2002-12-12
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K023180)Vanguard Medical Concepts, Inc.2002-12-12
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER (K023880)ETHICON, Inc.2002-12-11
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS (K023803)Biotronik, Inc.2002-12-11
KSEA DEPLOYABLE CARDIOVASCULAR CLAMP (K014277)KARL STORZ Endoscopy-America, Inc.2002-12-11
AGILTRAC .035 PERIPHERAL DILATATION CATHETER (K023320)Guidant Corp.2002-12-10
M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY (K023871)Philips Medical Systems2002-12-04
NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE (K023016)Nicore Equipment & Leasing, Inc.2002-12-04
PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE (K023700)Precision Vascular Systems, Inc.2002-12-04
PEDIATRIC ARTERIAL CANNULA (K023251)Polystan A/S2002-12-04
MODIFICATION TO ENVOY PATIENT MONITOR (K023798)Mennen Medical , Ltd.2002-12-03
T-WAVE ALTERMANS (TWA) ALGORITHM OPTION (K023380)General Electric Medical Systems Information Techn2002-12-03
NEWCOR (K020440)Siemens Medical Systems, Inc.2002-12-03
SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM (K022640)Bacchus Vascular, Inc.2002-12-02
TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH) (K023514)Bacchus Vascular, Inc.2002-12-02
PHILIPS DRUG CALCULATOR SOFTWARE (K023674)Philips Medical Systems2002-11-29
CHILLBUSTER (K022903)Microtek Medical, Inc.2002-11-27
ADAPTERS WITH X-COATING (K022918)Terumo Cardiovascular Systems Corporation2002-11-27
RECOVERY FILTER SYSTEM, MODEL RF-048F (K022236)C.R. Bard, Inc.2002-11-27
ENDOVASCULAR GUIDE WIRE (K021363)Stereotaxis, Inc.2002-11-27
CIRCUIT TUBINGS WITH X-COATING (K023056)Terumo Cardiovascular Systems Corp.2002-11-26
RENEGADE STC 18 MICROCATHETER (K023681)Boston Scientific Corp2002-11-26
EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION (K021397)Biosphere Medical, Inc.2002-11-22
STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 (K023622)Stockert Instrumente GmbH2002-11-21
WIZAIR COMPRESSION SYSTEM (K023573)Medical Compression Systems (Dbn) , Ltd.2002-11-21
BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211 (K022916)K-Jump Health Co., Ltd.2002-11-21
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O (K023698)Philips Medical Systems2002-11-19
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B) (K023749)Philips Medical Systems2002-11-19
TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM (K022783)Tensys Medical, Inc.2002-11-19
PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM (K013913)Medtronic Percusurge, Inc.2002-11-15
VITALSAT SERIES (K011518)Beta Biomed Services, Inc.2002-11-15
SEER LIGHT COMPACT DIGITAL HOLTER RECORDER (K021470)General Electric Medical Systems Information Techn2002-11-14
REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS (K022753)Medical Device Services2002-11-14
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE (K022740)Datex-Ohmeda2002-11-14
SKINTACT ECG ELECTRODE (K023503)Leonhard Lang GmbH2002-11-14
QUANTIX/ND DEVICE (K023431)Cardiosonix, Ltd.2002-11-13
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER (K023504)Cook, Inc.2002-11-13
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M (K021239)Eikon Healthcare Device Corp.2002-11-08
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200 (K021240)Eikon Healthcare Device Corp.2002-11-08
PHILIPS M5066A AND M5068A (K020715)Philips Medical Systems2002-11-08
MODIFICATION TO GELBFISH VASCULAR DILATORS (K023507)Vascumetrix, LLC2002-11-08
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE (K020003)Bio Protech, Inc.2002-11-07
OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' (K014218)Dolphin Medical, Inc.2002-11-07
8F LAUNCHER GUIDE CATHETER (K023402)Medtronic Vascular2002-11-06
HEARTONE EVENT RECORDER AND TRANSMITTER (K023418)Aerotel Medical Systems (1998) , Ltd.2002-11-06
CO-AXIAL INTRODUCER NEEDLE (K022634)Promex, Inc.2002-11-06
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE (K023497)Datex-Ohmeda2002-11-04
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