Atlas FDA

Cardiovascular

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

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RecordFirmDate
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR (K871569)Cardiac Resucitator Corp.1987-06-08
CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300 (K871221)Cardiovascular Devices, Inc.1987-06-05
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS (K871861)Telectronics, Inc.1987-06-05
UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M (K871208)Pacesetter Systems1987-06-05
ELECTROTRACE DISP REST EKG ELECTRODE, CAT. ET1200 (K871626)Jason Marketing Co.1987-06-05
HYPERTENSION RISK DETECTOR(TM) (K871482)Pearce Clinical Laboratories, Inc.1987-06-05
MODIFIED MODEL UA-751 DIGITAL SPHYGMONOMETER (K871719)A&D Engineering, Inc.1987-06-05
MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE (K871363)Quinton, Inc.1987-06-05
ACUSON PHYSIOLOGICAL CONTROL MODULE (K871239)Acuson Computed Sonography1987-06-05
DORROS(TM) SMALL VESSEL PTA CATHETER (K870460)C.R. Bard, Inc.1987-06-05
DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER (K871149)Iontec Corp.1987-06-05
CONSULTANT BODY COMPOSITION ANALYZER (K871040)Body Composition Analog, Inc.1987-06-05
CENTRAL VEIN CATHERIZATION KIT W/WITHOUT MEDICA. (K870411)Medical Surgical Concepts, Inc.1987-06-02
POET OXIMETER (K864745)Criticare Systems, Inc.1987-06-02
PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR) (K870413)Medical Surgical Concepts, Inc.1987-06-01
IMS-2000S STRESS MONITOR (K871659)Integrated Medical Systems, Inc.1987-05-28
OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C (K871207)Omron Electronics, Inc.1987-05-28
ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) (K870016)Migada, Ltd.1987-05-28
CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D (K863969)Camino Laboratories, Inc.1987-05-27
TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT (K870412)Medical Surgical Concepts, Inc.1987-05-27
TDMAC-HEPARIN COATED RMI (K870421)Research Medical, Inc.1987-05-22
CIRCAMED FULL DISCLOSURE SYSTEM (K871251)Circadian, Inc.1987-05-22
ACS ENHANCED-TORQUE CORONARY GUIDING CATHETER (K871425)Advanced Cardiovascular Systems, Inc.1987-05-22
IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01 (K871580)Intermedics, Inc.1987-05-22
SARNS 9000 HEART-LUNG CONSOLE (K871131)3M Health Care, Sarns1987-05-21
C150-P ECG CABLES (K870926)Desco Industries, Inc.1987-05-21
IMPLANTABLE ELECTRODE LEAD, MODEL 030-439 (K864618)Telectronics, Inc.1987-05-21
MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER (K871625)Intermedics, Inc.1987-05-21
ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY (K870357)Intermedics, Inc.1987-05-21
FAST-PATCH(TM) (K871224)Physio-Control Corp.1987-05-20
DMI AMBULATORY HOLTER MONITOR (K871045)Diagnostic Medical Instruments1987-05-19
MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR (K870652)Medtronic Vascular1987-05-14
SIMPSON PERIPHERAL ATHEROCATH(TM) (K871011)Devices For Vascular Intervention, Inc.1987-05-14
HEARTSTART 2000, MANUAL DEFIBRILLATOR (K871136)First Medical Devices Corp.1987-05-12
40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER (K864567)Aries Medical, Inc.1987-05-12
40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER (K864568)Aries Medical, Inc.1987-05-12
HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE (K871135)First Medical Devices Corp.1987-05-12
DSP100 CAROTID PHONOANGIOGRAPHY MODULE (K864429)Intl. Acoustics, Inc.1987-05-12
CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO (K871412)Contour Electrodes, Inc.1987-05-12
RECORD KEEPING/DATA MANAGEMENT SYSTEM (K865035)Critical Care Systems, Inc.1987-05-11
IVR-SP CUSTOM ANGIOGRAPHY TRAY (K870419)North Coast Medi-Tek1987-05-11
CARDIAC PERFORMANCE MONITOR (K864583)Vascular Technology Incorporated1987-05-11
APPLICARD SYSTEM (ECG ELECTRODE SYSTEM) (K864260)Grandcor Medical Systems1987-05-11
3MHZ ANNULAR ARRAY (K864980)Philips Ultrasound, Inc.1987-05-11
NAMIC COURNAND STYLE INTRODUCER NEEDLE (K871377)North American Instrument Corp.1987-05-07
IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM (K870934)Integrated Medical Systems, Inc.1987-05-06
ONGUARD 1000, CATALOG #043611-000 & 043611-001 (K870976)Cobe Laboratories, Inc.1987-05-06
NAMIC ONE PART INTRODUCER NEEDLE (K871382)North American Instrument Corp.1987-05-06
SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR (K870829)3M Health Care, Sarns1987-05-06
IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL (K871333)Medtronic Vascular1987-05-06
ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD (K864690)Multi Biosensors, Inc.1987-05-06
MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER (K870301)Medex, Inc.1987-05-06
NAMIC SELDINGER INTRODUCER NEEDLE (K871378)North American Instrument Corp.1987-05-06
CORDAY CORONARY SINUS INFUSION CATHETER (K865074)Retroperfusion Systems, Inc.1987-05-06
VASOPULSE(TM)/MODEL 5000 (K863803)Sonicaid, Inc.1987-05-06
INVIVO PULSE OXIMETER, MODEL 4500 (K864730)Invivo Research Labs, Inc.1987-05-06
MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20 (K870067)Vygon Corp.1987-04-28
THORASTAT ATR-XXXX (K870792)Gish Biomedical, Inc.1987-04-28
BPA CARDIOVASCULAR PRESSURE AMPLIFIER (K870783)Fisher Imaging Corp.1987-04-27
#014160-TAB TUBING ROTATOR ADAPTOR (K870325)Clinical Connections, Inc.1987-04-27
PACEMAKER FUNCTION ANALYZER (K870909)Paceart, Inc.1987-04-27
CENTRAL VENOUS CATHETER (K870075)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-04-27
VASCATH VASCULAR CATHETER PLACEMENT KIT (K870542)Titan Medical, Inc.1987-04-27
MODEL MICRO ST AMBULATORY ECG MONITOR (K870537)Advanced Medical Products, Inc.1987-04-23
PACE 10 NON-INVASIVE EXTERNAL PACEMAKER (K871176)Medac, Inc.1987-04-23
MODEL 192 PRINTER (K870538)Advanced Medical Products, Inc.1987-04-23
EMT-102 CARDIAC MONITOR (K870049)Evergreen Medical Technologies, Inc.1987-04-22
PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR (K870142)Cardio-Pace Medical, Inc.1987-04-22
ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER (K871140)Aries Medical, Inc.1987-04-22
URESIL CAROTID ARTERY SIZERS (K871148)Uresil Corp.1987-04-22
SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM (K865101)Spectramed, Inc.1987-04-20
CARDIOTEAM (K870527)Cardiac Network, Inc.1987-04-20
PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS (K871132)Deltec Systems, Inc.1987-04-20
HEART*AID 1000 (K870622)Cardiac Resucitator Corp.1987-04-10
HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER (K861505)American Medical Equipment, Inc.1987-04-10
MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD (K870948)Intermedics, Inc.1987-04-10
FIBRE OPTIC STRIP CHART RECORDER (K870119)Apex Imaging Corp.1987-04-10
MD MONITORING/DIAGNOSTIC ELECTRODE (K870873)Lectec Corp.1987-04-10
ACKRAD TDI SET (K864818)Ackrad Laboratories1987-04-09
Q5000 STRESS TEST MONITOR (K864504)Quinton, Inc.1987-04-09
ADDITIONAL 13.4CM. FRENCH CATHETER INSERTION TRAY (K870675)Quinton, Inc.1987-04-09
MEDI-TECH SELECTIVE TORQUE CATHETER (K864118)Medi-Tech, Inc.1987-04-09
TITANIUM PERCUTANEOUS GREENFIELD VENA CAVE FILTER (K870729)Medi-Tech, Inc.1987-04-09
INTRODUCER, PERCUTANEOUS (K870907)Med Fusion Systems, Inc.1987-04-09
EK10 ELECTROCARDIOGRAPH (K870880)Burdick Corp.1987-04-09
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701 (K870728)A&D Engineering, Inc.1987-03-27
GUIDE WIRE (K870664)Datascope Corp.1987-03-25
FUKUDA DENSHI MODEL FCP-15 (K871025)Fukuda Denshi USA, Inc.1987-03-24
MODIFIED DRAGER SPHYGMOMED (K862427)Draeger Medical, Inc.1987-03-23
CASSETTE TAPE REPLAY SYSTEM (K870554)Research Instrumentation Associates, Inc.1987-03-23
ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN. (K870826)Shiley, Inc.1987-03-23
HEART TRACK (K864293)Cardio Telemetric Systems, Inc.1987-03-23
NEW MODEL STYLES FOR AORTIC ARCH CANNULA (K870825)Shiley, Inc.1987-03-23
TDK ECG ELECTRODE MEL-10 (K870834)Tdk Corp.1987-03-23
SATLITE/PB251 PULSE OXIMETER (K870621)Datex Division Instrumentarium Corp.1987-03-20
THE BUDDY SYSTEM/HEALTH INFORMATION SYSTEM (K864318)The Buddy Systems, Inc.1987-03-20
PM-8 HEART RATE MONITOR (K864748)Pulse Time Products, Ltd.1987-03-20
CARDIAN III CR6A (K864704)Cardiac Recorders, Ltd.1987-03-20
SHELF LIFE CHANGE OF STERILE DEVICES (K864090)Utah Medical Products, Inc.1987-03-20
CARDIOVIT AT-6 (K864465)Schiller Corp.1987-03-20
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