Atlas FDA

Cardiovascular

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

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RecordFirmDate
PRESS-O-TEST (K822102)Medi-Swiss Corp.1982-11-24
EXV VENOUS RESERVOIR BAG & HOLDER (K823205)Extracorporeal Medical Specialities, Inc.1982-11-24
CKG 8800 (K823215)Cardio Kinetics, Inc.1982-11-24
ROTARY VASCULAR KNIFE (K822829)Medco Products, Co., Inc.1982-11-17
HOLTER RECORDER (K822970)Agilent Technologies1982-11-03
AUTOECHO (K822903)Oxford Medilog, Inc.1982-11-01
MODEL 4242 TELE SYST ARRHYTHMIA MONITOR (K822955)Medtronic Vascular1982-11-01
560 (K822952)Kone Instruments, Inc.1982-11-01
PORTA FIB III (K822961)Narco Scientific1982-11-01
BALLOON WEDGE PRESSURE, ANGIOGRAPHIC (K822806)Nova Medical Specialties1982-11-01
MEDI-TRACE 5' OFFSET ELECTRODE (K822750)Graphic Controls Corp.1982-11-01
KALOS-03 BIPOLAR (K822907)Biotronik Sales, Inc.1982-11-01
INTRAOPERATIVE BALLOON DILATION CATH. (K822393)Advanced Cardiovascular Systems, Inc.1982-11-01
BLOOD OXYGENATORS #BOS-105S BOS-5S W/ (K822803)Bentley Laboratories, Inc.1982-11-01
WM. HARVEY H-1300 INFANT/PEDIATRIC BLOOD (K821477)C.R. Bard, Inc.1982-11-01
PULSE OXIMETER MODEL 100 (K822909)Nellcor, Inc.1982-11-01
IL 801 THERMALDILUTION CARDIAC OUTPUT (K822972)Instrumentation Laboratory CO1982-11-01
SARNS PULSATILE PUMP (K820729)3M Health Care, Sarns1982-11-01
ACCESS PERCUTANEOUS INTRODUCER SET (K822834)Access Devices, Inc.1982-11-01
CNIBP BLOOD PRESSURE MEASUREMENT SYS (K822055)Ohio Medical Products1982-11-01
CENTURION CHART RECORDER (K822432)Clinical Data, Inc.1982-11-01
OPTICATH HEPARIN COATED, FLOW-DIRECT (K823007)Oximetrix, Inc.1982-11-01
GAS-FLOW METER GFL 10 (K822820)Gambro, Inc.1982-10-18
MODEL 78534A PATIENT MONITOR (K822876)Hewlett-Packard Co.1982-10-18
THERMOSTATIC WATER MIXING VALVE TWV10 (K822874)Gambro, Inc.1982-10-18
MODEL 78554A DATA MGMT. PLUG-IN MODULE (K822877)Hewlett-Packard Co.1982-10-18
TEFLON COATED GUIDE WIRES & CATHETER (K822586)Universal Medical Instrument Corp.1982-10-18
GAMBRO PRESSURE MONITOR PRM 10 (K822822)Gambro, Inc.1982-10-18
LS6 ARRYTHMIA DISCRIMINATOR (K822616)Life Science Instrumentation, Inc.1982-10-18
NON-STETHO 7, UM-15TP (K821989)Hirata Sangyo Co. USA, Inc.1982-10-18
PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC (K820882)Datascope Corp.1982-10-18
BRACHIAL CORONARY GUIDING CATHETER (K822862)Advanced Cardiovascular Systems, Inc.1982-10-18
GAMBRO BLOOD LEVEL DETECTOR LCS 10 (K822821)Gambro, Inc.1982-10-18
MODEL 78553A PRESSURE PLUG-IN MODULE (K822878)Hewlett-Packard Co.1982-10-18
DIGITAL PULSE METER (73 BWS) #HRM-100E (K822692)Sanyo Electric, Inc.1982-10-15
SWAN-GANZ BIPOLAR PACING CATHETER (K822723)American Edwards Laboratories1982-10-15
BALLOON TEMP. PACING CATHETER (K822003)Ziehm International, Inc.1982-10-15
DISPOSABLE ELECTRODE #1900 (K822798)Andover Medical, Inc.1982-10-15
MODEL 325D UNIPOLAR CARDIAC PULSE GEN (K822904)Cook Pacemaker Corp.1982-10-15
SIGNAL DISTRIBUTION NETWORK #78581A (K822695)Hewlett-Packard Co.1982-10-15
BIPOLAR TEMP. PACING CATHETER W/STYLETET (K822002)Ziehm International, Inc.1982-10-15
ENERTRAX MODEL 7100E (K822297)Medtronic Vascular1982-10-04
COMMAND NP (K822309)Cardiac Pacemakers, Inc.1982-10-04
ALTA III ECG RECORDER (K822363)Scole Engineering Co.1982-10-04
REUSABLE FOGARTY FLEXIBLE CALIBRATOR (K822687)American Edwards Laboratories1982-10-04
JAIN INSULATING BOOT MODEL 225B (K822652)Cook Pacemaker Corp.1982-10-04
PRESSURE ISOLATION AMPLIFIER #9813 517 (K822590)Honeywell, Inc.1982-10-04
SERIES 7000 BEDSIDE PATIENT MONITOR (K822718)Marquette Electronics, Inc.1982-10-04
ELECTROCARDIOGRAPH (74 DPS) #YM-102 (K822768)Sanyo Electric, Inc.1982-10-04
CARDIO TEHCHANALYZER (K821711)Cardio Technology , Ltd.1982-10-04
COAXIAL BIPOLAR PACING ELECTRODE (K822239)Burditt & Calkins-Siemens-Elema1982-10-04
M-MODE ANALYSIS SYSTEM (K822425)User Resources, Inc.1982-10-04
MULTIPLE LEAD ARRHYTHMIA MODULE (K822030)Marquette Electronics, Inc.1982-09-28
PERCUTANEOUS CATHETER INTRODUCER SET (K822593)Vertex Medical Corp.1982-09-28
CUTANEOUS PRESSURE PLETHYSMOGRAPH (K822522)Life Sciences Manufacturing, Inc.1982-09-28
TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS (K822598)Vertex Medical Corp.1982-09-28
CORONARY INFUSION KIT (K822640)Mallinckrodt Critical Care1982-09-28
POLYETHYLENE CARDIOVASCULAR CATHETER (K822594)Vertex Medical Corp.1982-09-28
MARK V (K822536)Medrad, Inc.1982-09-28
VESSEL DILATOR (K822595)Vertex Medical Corp.1982-09-28
VASOGRAPH, MODEL MV-2 (K822455)Electro-Diagnostic Instruments1982-09-24
VERTEX PERCUTANEOUS PUNCTURE NEEDLE (K822596)Vertex Medical Corp.1982-09-21
QUIKPAGE SCANNER (K822582)Agilent Technologies1982-09-21
BIOMEGA MODEL 59W (K822438)Bio Mega Diagnostic, Inc.1982-09-21
STAT-SCAN (K822093)Survival Technology, Inc.1982-09-21
LIFE TRACE 24 (K822390)Life Science Instrumentation, Inc.1982-09-21
LIFE WATCH LSI (K822615)Life Science Instrumentation, Inc.1982-09-21
LIFE TRACE 40/42 (K822389)Life Science Instrumentation, Inc.1982-09-21
BLOOD PRESSURE MONITORING DEVICES (K822614)Allied Healthcare Products, Inc.1982-09-21
GUIDE WIRE (K822597)Vertex Medical Corp.1982-09-21
HEART MONITOR BRACELET ALARM (K822316)Hmba1982-09-21
DISPOSABLE TRANSDUCER & ACCESSORIES (K822507)Gould, Inc.1982-09-14
SINGLE CHANNEL NONFADE OSCILLOSCOPE (K822517)Quinton, Inc.1982-09-14
RE1000 HEART RATE MONITOR (K822319)Electronic Monitors, Inc.1982-09-14
ARGYLE CAROTID ARTERY LOOP SHUNT (K822317)Sherwood Medical Co.1982-08-31
VPD-261 DEFIBRILLATOR MONITOR (K822294)Life Science Instrumentation, Inc.1982-08-31
FRANKLIN QUANTIC 1200 (K822236)Bruce Franklin, Inc.1982-08-31
GUIDE WIRE (K821190)Advanced Cardiovascular Systems, Inc.1982-08-31
BARD PTFE VASCULAR PROSTHESIS (K821716)C.R. Bard, Inc.1982-08-31
INDEFLATOR (K822245)Advanced Cardiovascular Systems, Inc.1982-08-31
STERILE PROTECTIVE SLEEVE W/TOUGH-BORST (K822290)Universal Medical Instrument Corp.1982-08-31
QUINTON Q, SCAN MODELS 900 & 901 (K821758)Quinton, Inc.1982-08-25
HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85 (K821942)Harvey-Bostwick, Inc.1982-08-24
HIGH PRESSURE CONTRAST INJECTION LINE (K822100)Namic1982-08-24
GUIDING CATHETER (K822243)Interventional Medical, Inc.1982-08-24
ANGIOGRAPHIC CATHETER (K821816)Medi-Tech, Inc.1982-08-24
LIFE TRACE 14 (K822388)Life Science Instrumentation, Inc.1982-08-24
BALLOON WEDGE PRESSURE CATHETER (K822034)Ziehm International, Inc.1982-08-24
GAMBRO PUMP CONSOLE CSL (K822068)Gambro, Inc.1982-08-24
SARNS CARDIOPLEGIA CANNULAE (VAR. TYPES (K822210)3M Health Care, Sarns1982-08-24
PUMP MODULES PMO LO-110-PMD 10-210 (K822071)Gambro, Inc.1982-08-24
SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH (K822350)American Edwards Laboratories1982-08-24
BERMAN ANGIOGRAPHIC BALLOON CATHETER (K822033)Ziehm International, Inc.1982-08-24
ETHICON TEMPORARY CARDIAC PACING WIRE (K822155)ETHICON, Inc.1982-08-24
DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL (K821065)Datascope Corp.1982-08-19
CATH-SEAL (K822247)Universal Medical Instrument Corp.1982-08-19
PERIGUARD PERICARDIAL PATCH (K821532)Genetic Laboratories, Inc.1982-08-19
CAPIOX CR-CARDIOTOMY RESERVOIR (K821538)Terumo Medical Corp.1982-08-06
HEART*AID, ALS, MODEL 95 (K821673)Cardiac Resucitator Corp.1982-08-06
HEART AID #90 (K821152)Cardiac Resucitator Corp.1982-08-06
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