Atlas FDA

Cardiovascular

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

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RecordFirmDate
CARD GUARD, MODEL CG-6550 (K990478)Card Guard Scientific Survival , Ltd.1999-08-31
ENDOSONICS TRAK BACK DEVICE (K990271)Endosonics Corp.1999-08-30
TELEMEDICINE 2000 (K992164)Card Guard Scientific Survival , Ltd.1999-08-30
N-395 PULSE OXIMETER, MODEL N-395 (K991823)Nellcor Puritan Bennett, Inc.1999-08-25
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS (K992123)Boston Scientific Scimed, Inc.1999-08-23
K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 (K991007)Katecho, Inc.1999-08-23
ADVANTA GRAFT (K992443)Atrium Medical Corp.1999-08-20
ADVANTA GRAFT (K992441)Atrium Medical Corp.1999-08-20
MAGNATEK 30 (K991819)Magna Advanced Technologies, Inc.1999-08-19
ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR (K992413)Medical Data Electronics1999-08-19
JOSTRA HL-20 TWIN PUMP (K984338)Jostra Bentley1999-08-19
ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR (K992411)Medical Data Electronics1999-08-18
RADIFOCUS OPTITORQUE (K992051)Terumo Medical Corp.1999-08-10
KELLER VITAL SIGNS MONITOR, KMS 890+ (K990648)Keller Medical Specialties Products, Inc.1999-08-10
CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER (K984214)Cordis Neurovascular, Inc.1999-08-10
HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A (K991871)Hewlett-Packard Co.1999-08-05
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100 (K992387)Rossmax International , Ltd.1999-08-03
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200 (K992388)Rossmax International , Ltd.1999-08-03
HT, MODEL HT PB (K990142)Sulzer Oscor, Inc.1999-07-30
LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB (K983802)Lucas Medical, Inc.1999-07-30
AVE GL-1 GUIDING CATHETER (K984482)Arterial Vascular Engineering Massachusetts, Inc.1999-07-30
MODIFICATION TO ZYMED HOLTER 2000 (K992197)Zymed Medical Instrumentation1999-07-28
VOYAGER QUAD CANNULA (K983270)Cardiothoracic Systems, Inc.1999-07-28
AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER (K984627)Arterial Vascular Engineering, Inc.1999-07-27
PVS 1400 GUIDEWIRE (K990823)Precision Vascular Systems, Inc.1999-07-23
FOUNTAIN Infusion Catheter and Occluding Guide Wire (K992231)Merit Medical Systems, Inc.1999-07-23
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION (K990476)Hewlett-Packard GmbH1999-07-22
SCIMED ANGIOGRAPHIC CATHETERS (K992142)Scimed1999-07-21
FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800 (K992328)Meditec Co., Ltd.1999-07-21
MEDRAD VISTRON CT INJECTOR SYSTEM (K991557)Medrad, Inc.1999-07-21
DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF (K991525)Deroyal Industries, Inc.1999-07-20
MEDITRON STETHOSCOPE SYSTEM (K991367)Meditron AS1999-07-19
MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER (K991001)Ep Medsystems1999-07-15
EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR (K983940)Adam Spence Corp.1999-07-15
SOLAR 9500 INFORMATION MONITOR (K990068)General Electric Medical Systems Information Techn1999-07-14
EPTFE RINGED GORE-TEX VASCULAR GRAFT (K991602)W. L. Gore & Associates, Inc.1999-07-09
ATLAS MONITOR (K984033)Welch Allyn, Inc.1999-07-08
EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM (K991211)Reynolds Medical , Ltd.1999-07-08
RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 (K991170)Edwards Lifesciences Research Medical1999-07-02
SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 (K991169)Biotronik, Inc.1999-07-01
FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS (K984586)Fresenius Hemotechnology, Inc.1999-06-29
MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET (K990705)Medamicus, Inc.1999-06-28
6F HYDROLYSER THROMBECTOMY CATHETER (K990771)Cordis Corp.1999-06-25
MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS (K991775)Mennen Medical, Inc.1999-06-24
CAPIOX CARDIOPLEGIA (K982467)Terumo Medical Corp.1999-06-23
NAVIPORT DEFLECTABLE TIP GUIDING CATHETER (K974683)Cardima, Inc.1999-06-22
ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE (K991898)Microvena Corp.1999-06-16
CORDIS MAXI DS PTA BALLOON CATHETER (K991811)Cordis Corp.1999-06-15
TELEMEDICINE 2000 (K991307)Card Guard Scientific Survival , Ltd.1999-06-14
BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 (K990956)Biosensor Corp.1999-06-14
CARDIOLIGHT (K982448)Capintec, Inc.1999-06-11
PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA (K983791)Edwards Lifesciences Research Medical1999-06-11
BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1 (K991831)Boston Medical Technologies, Inc.1999-06-11
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 (K991102)Guidant Corp.1999-06-09
3402 HANDHELD PULSE OXIMETER (K991410)Bci Intl., Inc.1999-06-09
CADISCOPE ELECTRONIC STETHOSCOPE (K990809)Caditec AG1999-06-09
FOUNTAIN Infusion Catheter and Occluding Guide Wire (K991619)Merit Medical Systems, Inc.1999-06-09
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES (K990795)Cardiac Pathways Corp.1999-06-08
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P (K991773)Hewlett-Packard GmbH1999-06-07
MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS (K990966)Masimo Corp.1999-06-07
SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM (K983996)Spacelabs Medical, Inc.1999-06-03
ORTHOGONAL EP CATHETERS (K990958)Irvine Biomedical, Inc.1999-06-03
RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 (K990483)Biotronik, Inc.1999-06-03
WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S (K991688)Jawon Medical Co., Ltd.1999-06-01
UNI-GRAFT K DV VASCULAR GRAFT (K991813)Atrium Medical Corp.1999-06-01
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER (K991661)Siemens Medical Solutions USA, Inc.1999-05-28
CORDIS TEMPO ANGIOGRAPHY CATHETER (K991673)Cordis Corp.1999-05-26
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (K990239)Cobe Cardiovascular, Inc.1999-05-25
WALKCARE P200 SYSTEM (K973592)A.Stein - Regulatory Affairs Consulting1999-05-20
WRIST BLOOD PRESSURE METER MODEL SE-330 (K973078)Sein Electronics Co., Ltd.1999-05-20
FLEXIBLE VASCULAR CLAMP, VERSION 2 (K991589)Allegiance Healthcare Corp.1999-05-18
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX (K983575)Datascope Corp.1999-05-13
ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW (K990093)Agilent Technologies1999-05-11
TRACER O-T-W MAPPING DEVICE (K972803)Cardima, Inc.1999-05-11
EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF (K983039)Schneider/Namic1999-05-07
MODIFICATION TO ULTRA-SELECT GUIDEWIRE (K991194)Microvena Corp.1999-05-05
LIFEPAK 500 BIPHASIC (K983393)Physio-Control Corp.1999-05-05
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65 (K990829)Arrow Intl., Inc.1999-05-04
HI-TORQUE BALANCE TREK GUIDE WIRE (K991152)Guidant Corp.1999-04-29
TRINITY II SINGLE CHAMBER DVT PUMP (K983680)Delphi Consulting Group1999-04-28
BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471 (K984223)Citizen Watch Co., Ltd.1999-04-28
COWBOY XV (K981311)Kci New Technologies, Inc.1999-04-23
BI-DIRECTIONAL TUNNELER (K991027)Impra, Inc.1999-04-22
ENSITE 3000 SYSTEM (K983456)Endocardial Solutions, Inc.1999-04-21
QUICKDRAW VENOUS CANNULA (K981995)Heartport, Inc.1999-04-20
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T (K990972)Hewlett-Packard GmbH1999-04-19
COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER (K983830)Mallinckroot, Inc.1999-04-16
HOLTER 2000 (K990170)Zymed Medical Instrumentation1999-04-13
PVR-100/VASOGRAM (K990123)Vasocor, Inc.1999-04-12
CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000 (K983102)Cambridge Heart, Inc.1999-04-12
TRACER (K982617)Heartland Medical Systems, Inc.1999-04-09
EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09 (K990082)Epic Medical Equipment Services, Inc.1999-04-09
ACUSEAL CARDIOVASCULAR PATCH (K984526)W. L. Gore & Associates, Inc.1999-04-08
ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT (K982365)Geister Medizin Technik GmbH1999-04-08
ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 (K981191)Intratherapeutics, Inc.1999-04-07
ENVY GUIDING CATHETER (K990726)Cook, Inc.1999-04-02
ADVANCED NIBP MODULE (K982641)Johnson & Johnson Medical, Inc.1999-03-29
MICRINS MICRO ANASTOMOSIS CLAMP (K982278)Micrins Surgical, Inc.1999-03-26
ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING. (K990639)Guidant Corp.1999-03-25
BCI MINI-TORR PLUS, MODEL 6004 (K984618)Bci Intl., Inc.1999-03-25
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