Atlas FDA

Cardiovascular

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

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RecordFirmDate
CORDIS STEERABLE GUIDEWIRE (K952067)Cordis Corp.1995-07-20
IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER (K946333)Irvine Biomedical, Inc.1995-07-18
NEWOX2 (K945754)Bci Intl., Inc.1995-07-17
SPECTRADOP (K925078)Bennett and Assoc., Inc.1995-07-17
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 (K944957)Medtronic Blood Systems, Inc.1995-07-14
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 (K944956)The Heart Valve Div. Medtronic Cardiovascular Surg1995-07-14
ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS (K942543)Sankei Co., Ltd.1995-07-14
SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM (K951605)Spacelabs, Inc.1995-07-14
UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 (K944966)Medtronic Blood Systems, Inc.1995-07-14
PARAMETERS MONITORES (K945099)Ivy Biomedical Systems, Inc.1995-07-13
PELLETHANE 75D (K940039)Medtronic Vascular1995-07-12
URESIL(R) GUIDEWIRE (K945934)Uresil Corp.1995-07-10
ECG ELECTRODE (K944260)Msb , Ltd.1995-07-07
MEDI-TRACE(R) 500 ECG ELECTRODE (K945479)Graphic Controls Corp.1995-07-07
GRAPHIC CONTROLS PROTRACE ECG ELECTRODE (K950485)Graphic Controls Corp.1995-07-07
GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE (K950489)Graphic Controls Corp.1995-07-03
PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 (K945985)Burdick, Inc.1995-07-03
GRAPHIC CONTROLS BIOTAC ECO ELECTRODE (K950488)Graphic Controls Corp.1995-07-03
SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS (K944219)Gish Biomedical, Inc.1995-06-30
TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD (K951087)Pacesetter, Inc.1995-06-29
MODEL PV2000 VASCULAR MICROLABORATORY (K951486)Vasamedics, LLC1995-06-29
Kaplan-Simpson InfusaSleeve II Catheter (K952317)Localmed, Inc.1995-06-28
QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH (K945626)Quinton, Inc.1995-06-28
3050 DIASCOPE NT PATIENT MONITOR (K942196)S & W Medico Teknik A/S1995-06-28
SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEM (K946306)Siemens Medical Solutions USA, Inc.1995-06-27
FLEXFINDER GUIDEWIRE (K943390)Flexmedics1995-06-27
MEDAMICUS PERCUTANEOUS INTRODUCER (K951313)Medamicus, Inc.1995-06-27
DIDECO PEDIATRIC ARTERIAL FILTERS (K945198)Sorin Biomedical, Inc.1995-06-27
MEMORYTRACE ATM MODEL 4222 (K941898)Hi-Tronics Designs, Inc.1995-06-26
DYNAPULSE 5000A (DP5000A) (K945111)Pulse Metric, Inc.1995-06-23
SCIMED EXPO ANGIOGRAPHIC CATHETER (K951720)Scimed Life Systems, Inc.1995-06-22
BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES (K951307)Baxter Healthcare Corp1995-06-22
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 24F INTRODUCER SYSTEM (K951508)Boston Scientific Corp1995-06-22
BRAUN PTA BALLOON CATHETER (K951248)B.Braun Medical, Inc.1995-06-22
SCIMED CHOICE PT PLUS(RM) PTCA GUIDE WIRE (K950216)Scimed Life Systems, Inc.1995-06-22
COWBOY X (K944567)Kinetic Concepts, Inc.1995-06-21
BRAUN MANIFOLD (K942391)B.Braun Medical, Inc.1995-06-21
FOCUS BALLOON DILATATION CATHETER (K952064)Cardiovascular Dynamics, Inc.1995-06-21
LEMAITRE VALVULOTOME II (K946352)Vascutech, Inc.1995-06-21
MAXIMA PLUS HOLLOW FIBER OXYGENATOR (K941473)Medtronic Vascular1995-06-21
EVOLUTION(TM) MICROCATHETER (K945666)Boston Scientific Corp1995-06-21
1800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES (K945836)Conmed Andover Medical, Inc.1995-06-20
CARBOMEDICS EXENDED MITRAL ROTATOR (K951368)Carbomedics, Inc.1995-06-20
SCHOLAR PATIENT MONITOR (K944860)Criticare Systems, Inc.1995-06-20
DINAMAP PLUS VITAL SIGNS MONOITOR (K943709)Critikon Company, LLC1995-06-16
PULSE*SPRAY INFUSION SYSTEM (K951509)Angiodynamics, Div. E-Z-Em, Inc.1995-06-16
STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY (K912035)Boston Scientific Corp1995-06-15
MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE (K934086)Medrad, Inc.1995-06-15
QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS (K951088)Quest Medical, Inc.1995-06-14
PULSE*SPRAY INFUSION SYSTEM (K951602)Angiodynamics, Div. E-Z-Em, Inc.1995-06-14
0.035 IN. WISE WIRE (K942927)Boston Scientific Corp1995-06-13
C-THRU CORONARY GUIDE WIRE (K951109)Schneider (Europe) GmbH1995-06-08
SONICAID MODEL MR-63 AMBULATORY ECG RECORDER (K943862)Oxford Instruments Medical Systems1995-06-07
PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING (K945379)Boston Scientific Corp1995-06-05
HEARTRAC ECG MONITORING SYSTEM (K934913)Cardiac Telecom Corp.1995-06-05
DPD DEFIBRILLATOR (K952085)Medical Research Laboratories, Inc.1995-06-05
PROTECTIVE SHORTS (K943948)Y. Daneshvar, M.D.1995-06-05
MODEL 3200 VASCULAR MINI-LAB (K944495)Parks Medical Electronics, Inc.1995-06-02
NAVIGUIDE HYDROPHILIC GUIDE WIRE (K943358)Meadox Medicals, Div. Boston Scientific Corp.1995-06-02
NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER (K945909)Navarre Biomedical , Ltd.1995-06-02
AORTIC ARCH CANNULAS (K943934)Sorin Group Italia S.R.L.1995-06-02
HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER (K932388)Heart Rhythm Technologies, Inc.1995-05-31
SCIMED GATEWAY PLUS (K951089)Scimed Life Systems, Inc.1995-05-31
ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS (K950855)Adam Spence Corp.1995-05-30
SCIMED CHOICE PT PTCA GUIDE WIRE (K950835)Scimed Life Systems, Inc.1995-05-25
QUEST ANTEGRADE CARDIOPLEGIA CANNULA (K950814)Quest Medical, Inc.1995-05-25
BSM-8800A BEDSIDE MONITOR (K944422)Nihon Kohden America, Inc.1995-05-24
NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350A (K935877)Nihon Kohden America, Inc.1995-05-24
EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP) (K950687)Belmont Instrument Corp.1995-05-24
TC 3000 (K942881)Gaymar Industries, Inc.1995-05-23
HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR (K950483)Hewlett-Packard Co.1995-05-22
SCIMED(R) VENTURE(TM) II INFUSION CATHETER (K945904)Scimed Peripheral Interventions1995-05-19
DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 (K945065)Sorin Biomedical, Inc.1995-05-19
PULSE*SPRAY INFUSION SYSTEM (K950907)Angiodynamics, Div. E-Z-Em, Inc.1995-05-17
OPTA 5(TM) 5F PTA BALLOON CATHETER (K950119)Cordis Corp.1995-05-17
GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE (K950487)Graphic Controls Corp.1995-05-17
GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE (K950486)Graphic Controls Corp.1995-05-17
TELPHONIC STETHOSCOPE (K945638)American Telecare, Inc.1995-05-17
1700 MONITORING ECG ELECTRODE (K946273)Conmed Andover Medical, Inc.1995-05-17
SPACELABS MEDICAL ECG MODULE (MODEL 90492) (K942058)Spacelabs Medical, Inc.1995-05-17
PICIS CHART+ (K950536)Picis1995-05-17
TRANSIT-2 INFUSION CATHETER (K950909)Cordis Neurovascular, Inc.1995-05-16
TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES (K950751)Medtronic Vascular1995-05-15
ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS (K950752)Advanced Cardiovascular Systems, Inc.1995-05-15
AVD INTIMAX THROMBECTOMY CATHETER (K950586)Applied Medical Resources1995-05-15
CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER (K946188)Cardiac Control Systems, Inc.1995-05-15
ECG MONITOR (K944262)Fukuda Denshi USA, Inc.1995-05-12
CMS SYSTEM (K922528)Micromedical Industries, Ltd.1995-05-12
NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000 (K942347)Nellcor, Inc.1995-05-12
PROPAQ 200 MONITOR (K945071)Protocol Systems, Inc.1995-05-10
MARINR SERIES EP DIAGNOSTI CATHETERS (K951347)Medtronic Cardiorhythm1995-05-10
1481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED (K945384)Siemens Medical Solutions USA, Inc.1995-05-10
EMI MODEL FFF-IA (K952164)New York Heart Instruments, Inc.1995-05-10
ELCAT D-PPG, PLETHYSMOGRAPH DEVICE (K944395)Dermatology Assoc.1995-05-10
VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR (K941215)Sorin Biomedical, Inc.1995-05-10
CARDIAC EVENT RECORDER (INSTANT MEMORY 2000) (K942586)Telescan Medical Systems1995-05-10
HOLTER SSR DIGICORDER(TM) (K942653)Del Mar Avionics1995-05-10
MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND (K942072)Mabis Healthcare, Inc.1995-05-10
CVD BULLET INFUSION CATYHETER (K951502)Cardiovascular Dynamics, Inc.1995-05-10
ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON (K945230)Arrow Intl., Inc.1995-05-09
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