Atlas FDA

Cardiovascular

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

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RecordFirmDate
RMI CAROTID BY-PASS SHUNT (K860988)Research Medical, Inc.1986-05-21
STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL (K860920)Shiley, Inc.1986-05-21
QMED SYSTEM 2150 (K861437)Qmed, Inc.1986-05-20
TELEFLEX TEFLON COATED GUIDEWIRE (K860258)Teleflexmedical, Inc.1986-05-20
PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET (K860307)Teleflex, Inc.1986-05-20
LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS (K861464)Pacesetter Systems1986-05-19
CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM (K861359)Hewlett-Packard Co.1986-05-16
DINAMAP VITAL SIGNS MONITOR MODEL 8100 (K854434)Critikon Company, LLC1986-05-16
PULSE OXIMETER (K855027)Physio-Control Corp.1986-05-16
MODEL 535 NEO-TRAK RECORDER (K855045)Ge Medical Systems Information Technologies1986-05-16
ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY) (K861483)Mallinckrodt Critical Care1986-05-15
LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO (K861440)Pacesetter Systems1986-05-13
VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET (K861745)Keeler Instruments, Inc.1986-05-13
TRANSCOR (TM) RADIO-STETHOSCOPE (K854772)K & S Medicorp1986-05-13
OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 901 (K860196)Cas Medical Systems, Inc.1986-05-12
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-731 (K854797)Takeda Medical, Inc.1986-05-09
SALTZMAN STETHOSCOPE HEAD (K854771)K & S Medicorp1986-05-09
MONARK 869 ERGOMETER (K855102)Equilibrated Bio Systems, Inc.1986-05-09
FASTRACE III, ECG ELECTRODE (K860636)Andover Medical, Inc.1986-05-09
VICKERS MEDICAL MODEL 271 HEART RATE MONITOR (K854597)Vickers , Ltd.1986-05-09
SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS (K861559)Cook Pacemaker Corp.1986-05-09
BIOMECCA CARETAKER 1000 & 2000 (K860790)Biomecca Australia , Ltd.1986-05-08
VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX VASPORT SER (K854610)Gish Biomedical, Inc.1986-05-08
MEADOS INTRAORTIC GRAFT (K841596)Meadox Medicals, Div. Boston Scientific Corp.1986-05-08
ECG MONITORING/DEFIBRILLATION ELECTRODE (K854433)Andover Medical, Inc.1986-05-08
PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337 (K860805)Gould, Inc.1986-05-08
ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS (K860652)Hewlett-Packard Co.1986-05-08
EM STRESS ELECTRODE (K860827)Electromed Intl., Ltd.1986-05-08
KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT (K860427)Kontron Instruments, Inc.1986-05-07
MEADOX MEDICALS INC. GRAFT SIZER (K854431)Meadox Medicals, Div. Boston Scientific Corp.1986-05-07
TDK ECG ELECTRODE MEL-08-09 & -11 (K854596)Tdk Corp.1986-05-07
DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE (K853996)Transamerica Delaval, Inc.1986-05-07
DJP UNIPOLAR (K853567)Biotronik Sales, Inc.1986-05-07
DJ UNIPOLAR (K853566)Biotronik Sales, Inc.1986-05-07
PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A (K854840)Ivy Biomedical Systems, Inc.1986-05-07
SYNCARE TEMPORARY CARDIAC PACING WIRE (K861409)Gyneco, Inc.1986-05-05
PHARMASEAL DUAL LUMEN CATHETER (K861165)American Pharmaseal Div. Ahsc1986-05-05
MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER (K860435)Multigon Industries, Inc.1986-05-05
CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST (K861082)Cordis Corp.1986-05-05
STETHOSCOPE ELECTRONIC STETHOSCOPE SPHYGMOMANOMETE (K854356)Fontaine Industries, Inc.1986-05-05
NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH (K860526)Nova Medical Specialties1986-05-02
PROGRAMALITH III PULSE GENERATOR (K861140)Pacesetter Systems1986-05-02
BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER (K861240)Mountain View Medical1986-05-02
ANGIOMAT 6000 (K860204)Mallinckrodt Group, Inc.1986-05-02
595 ARRHYTHMIA MONITORING SYSTEM (K852250)Burdick Corp.1986-05-02
SCM-400 HOLTER SYSTEM (K860950)Fukuda Denshi USA, Inc.1986-05-02
HEART CATHETERIZATION TRAY (K860161)Medical Design Concepts, Inc.1986-05-02
DCI MODEL EP-2 CLINICAL STIMULATOR (K854196)Digital Cardiovascular Instruments, Inc.1986-05-01
HEARTSTART 2000 (K860676)First Medical Devices Corp.1986-04-30
DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST (K860470)Del Mar Avionics1986-04-30
ETP 180 CARDIAC PACEMAKER (EXTERNAL) (K860551)Biotronics Corp.1986-04-30
DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER (K860471)Del Mar Avionics1986-04-30
MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER (K861176)Intermedics, Inc.1986-04-29
CARDIO-COOL (K860523)Bio-Vascular, Inc.1986-04-29
SUBCLAVIAN INTRODUCER SET (K860898)Infusaid Corp.1986-04-29
BARD PARKER PERFUSION CATHETER (K855201)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-04-29
PERCUTANEOUS CATHETERS (K861008)Micor, Inc.1986-04-29
SPACELABS MEDICAL WORKSTATION (K860834)Spacelabs, Inc.1986-04-29
SARNS OXYGENATOR SYSTEM (K860539)3M Health Care, Sarns1986-04-29
PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3 (K860287)Healthcheck Corp.1986-04-28
GUIDE WIRE INTRODUCER (K860841)Target Therapeutics1986-04-28
MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR (K854370)Nihon Kohden America, Inc.1986-04-28
5000 SERIES ECG ELECTRODES (K854757)Alternative Design Systems, Inc.1986-04-23
CATHETER INTRODUCER (K860958)Target Therapeutics1986-04-23
MODIFIED CHERNE CAD DETECTOR (K860015)Cherne Industries, Inc.1986-04-23
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 (K860546)Pacesetter Systems1986-04-23
MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER (K861110)Intermedics, Inc.1986-04-23
MEADOX SURGIMED GUIDE CATHETER (K860429)Meadox Surgimed, Inc.1986-04-23
BIPOLAR CARDIAC PACEMAKER, MODEL 110 (K861009)Cardiac Control Systems, Inc.1986-04-23
MODEL E 600 ELECTROCARDIOGRAPH (K860767)Kone Instruments, Inc.1986-04-23
ANGIOJECT (K860842)Target Therapeutics1986-04-23
GUIDED WIRE TORQUER (K860840)Target Therapeutics1986-04-23
EM ELECTRODE (K853774)Electromed Intl., Ltd.1986-04-17
OMRON DIGITAL BP MONITOR HEM-700CP (K854201)Omron Tateisi Electronics Co.1986-04-17
BIOMECCA CENTRAL CS1 (K854639)Biomecca Australia , Ltd.1986-04-17
CARDIOFAX ECG-6353 (K860212)Nihon Kohden America, Inc.1986-04-17
CURITY PERCUTANEOUS CATHETER INSERTION KIT (K855061)The Kendal Co.1986-04-16
CURITY PERCUTANEOUS CATHETER INSERTION TRAY (K855060)The Kendal Co.1986-04-16
ANGIOMED GUIED WIRES (K854912)Angiomed U.S., Inc.1986-04-16
PMS PERCUTANEOUS PUNCTURE NEEDLE (K854941)Professional Medical Services1986-04-16
CD-200 CARDIAC MONITOR (K860175)Cardio Display Corp.1986-04-15
ULTRASONIC COUPLANT GEL (K854996)Johnson & Johnson Professionals, Inc.1986-04-14
BOMED-CDM (K853706)Bomed Medical Mfr., Ltd.1986-04-14
ECG-ELECTRODE(SWAROMED) (K853939)D. Swarovski & Co.1986-04-11
MODEL 509A PHYSIOCORDER AMBULATORY RECORDER (K854269)Del Mar Avionics1986-04-11
LONG TERM RECORDER RAG 1200 (K854866)Nihon Kohden America, Inc.1986-04-09
RIGHT ATRIAL CATHETER CATALOG NO. RAC - XXX SERIES (K860699)Intracath, Inc.1986-04-02
STABLELINE (K860298)Cardio Metrics, Inc.1986-04-02
PERCUTANEOUS INTRODUCER KIT (K860432)Cormed, Inc., Sub. C.R.Bard, Inc.1986-03-31
VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015 (K860149)Dlp, Inc.1986-03-31
TUBING CONNECTORS (K860291)Biomedical Exports, Inc.1986-03-31
NONINVASIVE TEMP. PACEMAKER NTP-1000 (K855015)Zmi Corp.1986-03-31
CUP MONITORING KIT CVPK-14 (K854984)Medical Components, Inc.1986-03-31
REGULATED PRESSURE INJECTOR (K860806)Target Therapeutics1986-03-31
MODEL 366-19 ADAPTAID ADAPTER SLEEVE (K860985)Intermedics, Inc.1986-03-31
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES (K854830)Advanced Cardiovascular Systems, Inc.1986-03-31
PRODIGY AND PRODIGY PLUS (K860167)Cardiodata Corp.1986-03-31
UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762 (K852973)Ela Medical, Inc.1986-03-31
DEFIB-PADS (K855082)Conmedcorp1986-03-31
FUKUDA DENSHI CARDIMAX FCP-211 (K860024)Brentwood Instruments, Inc.1986-03-31
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