Atlas FDA

Cardiovascular

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

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RecordFirmDate
COBE DISPOSABLE PRESSURE TRANSDUCER (K810637)Cobe Laboratories, Inc.1981-04-23
MEDRAD HIGH PRESSURE CONECTING TUBE (K810924)Medrad, Inc.1981-04-17
SHILEY S-100A (ADULT) BLOOD OXYGENATOR (K810470)Shiley, Inc.1981-04-17
SONTEK ANGIOGRAPHIC CATHETER (K810508)Sontek Corp.1981-04-17
CORDIS BIOPSY FORCEPS (K810849)Cordis Corp.1981-04-17
INSULATIVE COATING FOR CARD. PULSE GEN (K810901)Intermedics, Inc.1981-04-14
ELECTRODE/PACER SYSTEM ANALYZER PMA 400 (K810604)Telectronics, Inc.1981-04-14
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE (K810603)Telectronics, Inc.1981-04-14
SINGLE USE SELDINGER/COURNAND PERC. NDL (K810859)Procedure Products, Inc.1981-04-11
PHARMALOG (K810698)Circadian, Inc.1981-04-10
NON-INVASIVE AMPLIFIER (K810828)Henry Ford Hospital1981-04-10
DOPSCAN MODEL 1050 (K810561)Carolina Medical Electronics1981-04-10
UNIVERSAL PACING ELECTRODE KIT (K810643)Stanco Medical, Inc.1981-04-08
ATRIAL-VENTRICULAR PACING ELECTRODE KIT (K810642)Stanco Medical, Inc.1981-04-08
TEMPTRON #'S 6804/6805 (K810657)Medtronic Vascular1981-04-08
NEONATAL BLOOD PRESSURE CUFF (K810838)Invivo Research Labs, Inc.1981-04-03
CARDIOPULMONARY BYPASS (K810820)Dlp, Inc.1981-04-03
SHILEY OXYGENATOR THERMISTOR PROBE (K810647)Shiley, Inc.1981-04-03
SQUINN VITATEK 500 SERIES PHYSIOL. MONI (K810755)Vitatek1981-04-03
INTERMEDICS CYBERLITH I BIOPOLAR CARDI (K810383)Intermedics, Inc.1981-04-01
CYBERLITH I PULSE GENERATOR MODEL 253-04 (K810385)Intermedics, Inc.1981-04-01
SIEMENS MODEL 146-146A EXTERNAL PULSE G (K810566)Cynergy1981-04-01
ARROW RADIAL ARTERY CATHETERIZATION SET (K810675)Arrow Intl., Inc.1981-03-27
PHYSIOLOGIC RECORDER (K810696)Honeywell, Inc.1981-03-27
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE (K810750)General Electric Co.1981-03-27
GANZ CORONARY REPERFUSION CATHETER (K803270)American Edwards Laboratories1981-03-27
MODEL SP5107 THERMODILUTION CATHETER (K810730)Gould, Inc.1981-03-27
SWAN-GANZ FLOW-DIRECTED THERMODILUTION (K810352)American Edwards Laboratories1981-03-27
CATHDAMP (K810661)Medline Industries, Inc.1981-03-27
MODEL IM1000 INTEGRATED MONITOR (K810731)Gould, Inc.1981-03-27
DATAMEDIX PECGASYS SYSTEM (K810027)Datamedix1981-03-26
LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM (K810154)Physio-Control Corp.1981-03-26
TYPE YC ENDOCARDIAL LEAD (K810491)Biotronik Sales, Inc.1981-03-20
TYPE YR ENDOCARDIAL LEAD (K810492)Biotronik Sales, Inc.1981-03-20
CORDIS PACEMAKER PROGRAMMERS 255A & 256A (K810552)Cordis Corp.1981-03-20
TYPE N ENDOCARDIAL LEAD (K810493)Biotronik Sales, Inc.1981-03-20
DUO-TEL (K810331)General Electric Co.1981-03-20
CARDIOPULMINARY BYPASS CATHETER CANNULA (K810548)Dlp, Inc.1981-03-17
QUINTON LTE ELECTRODE (K810563)Quinton, Inc.1981-03-17
SARNS TWO-STATE WIRE REINFORCED CATHETER (K810415)3M Health Care, Sarns1981-03-17
CARDIOMEMO (K803286)Instromedix, Inc.1981-03-17
THINLITH II PULSE GNEERATOR MODEL 227-05 (K810386)Intermedics, Inc.1981-03-13
CORDIS PERVENOUS ATRIAL LEAD (K810432)Cordis Corp.1981-03-13
ELECTRODE, PACEMAKER PERMANENT (K810582)Pacesetter Systems1981-03-13
TEMPORARY MYOCARDIAL PACING LEAD#6400 (K810333)Medtronic Vascular1981-03-13
BURRON CENTRAL VEIN CATHERIZATION KIT (K810461)Burron Medical Products, Inc.1981-03-11
KONTRON PERCUTAEOUS DOUBLE-LUMEN (K802924)Avco Medical Products1981-03-11
NARCO TLECARE MINIATURE PRESSURE DOME (K810431)Narco Bio-Systems1981-03-11
DISPOSABLE ELECTRODE FOR EKG (K803179)Midwest Monitoring1981-03-11
BURRON PERCUTANEOUS INDUCER SET (K810460)Burron Medical Products, Inc.1981-03-11
STRESS TEST SYSTEM (K810357)Nihon Kohden America, Inc.1981-03-11
BAIM TM CORONARY SINUS FLOW THERMAL (K810360)Electro-Catheter Corp.1981-03-11
SERIES 4000 STRESS & EXERCISE SYSTEM (K801903)Instruments For Cardiac Research1981-03-11
HEART SENTINEL (K802900)Totemite Medical Electronics1981-03-11
STERILE PACKAGING (K810410)Telectronics, Inc.1981-03-05
MEADOX SZILAGYI GRAFT (K810376)Meadox Medicals, Div. Boston Scientific Corp.1981-03-05
CPS-1000 (K802890)Gics Pharmaceuticals1981-03-05
AM 420 MICROPROCESSOR (K810163)Honeywell, Inc.1981-03-05
PRE-BYPASS FILTER (K810395)Texas Medical Products, Inc.1981-03-05
USCI CARDIOVASCULAR CATHETER (K810412)C.R. Bard, Inc.1981-03-05
OPTION 301 PACEMAKER EVAL. MODULE MAC-1 (K802368)Marquette Electronics, Inc.1981-03-04
IMPLANTABLE PACEMAKER LEAD ADAPTER (K810245)Intermedics, Inc.1981-03-04
ELECATH DUAL MODE TRANSTHORACIC PACING (K810312)Electro-Catheter Corp.1981-03-04
GUARDIAN MONITOR (CARDIOVASCULAR) (K803282)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-02-27
EAR OXIMETER (K810363)Bio-Tek Instruments, Inc.1981-02-27
1,2,3 CHANNELL RECORDERS (AR150,AR250,-) (K810166)Honeywell, Inc.1981-02-25
PERIPHERAL PULSE FUNCTION BLOCKS (K810171)Honeywell, Inc.1981-02-25
PATIENT MONITOR MODEL CM130, 140 (K810177)Honeywell, Inc.1981-02-25
PRESSURE FUNCTION BLOCKS (K810172)Honeywell, Inc.1981-02-25
DUAL TRACE VIDEO MONITOR VM 410 (K810165)Honeywell, Inc.1981-02-25
DUAL TRACE PATIENT MONITOR 116,118,120 (K810179)Honeywell, Inc.1981-02-25
ECG FUNCTION BLOCK (K810176)Honeywell, Inc.1981-02-25
CENTRAL STATION CONTROLLER AC100/CE100 (K810169)Honeywell, Inc.1981-02-25
PATIENT MONITOR CM111, 112 (K810178)Honeywell, Inc.1981-02-25
TREND GRAPH FUNCTION BLOCK (K810170)Honeywell, Inc.1981-02-25
SINGLE CHANNELL RECORDER AR110 (K810167)Honeywell, Inc.1981-02-25
SLAVE MONITORS DC109 & VS109 (K810168)Honeywell, Inc.1981-02-25
VC 430 VIDEO CONVERTER (K810164)Honeywell, Inc.1981-02-25
PACING SYSTEM ANALYZER (K803313)Medtronic Vascular1981-02-23
UNIFOCAL 3 (K810121)American Pacemaker Corp.1981-02-23
DISPOSABLE DIAPHRAGM DOME (K810009)Medex, Inc.1981-02-19
PORTABLE, BATTERY OPERATED DEFIBRILLATOR (K810237)Honeywell, Inc.1981-02-19
MICROPROCESSOR CONTROLLED ELECTROCARDIO (K810263)Honeywell, Inc.1981-02-19
MULTI-PROGRAMMABLE PACEMAKER & PROGRMR. (K801584)Medtronic Vascular1981-02-12
TELEMETRY PACEMAKER MONITOR (K802357)Intermedics, Inc.1981-02-12
POLY FLEX IMPLANTABLE PACING LEAD (K802295)Intermedics, Inc.1981-02-09
PACEMAKER PATIENT MGMT. SYSTEM (K801810)Siemens Elema AB1981-02-05
CORDIS MULTIFILAR PERVENOUS VENTRIC. LD (K810202)Cordis Corp.1981-02-05
CORDIS TEMPORATY CURVED ATRIAL LEAD (K810041)Cordis Corp.1981-02-05
SIEMENS-ELEMA PULSE GENERATOR 678 (K802864)Siemens Elema AB1981-02-05
FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06 (K810162)American Edwards Laboratories1981-02-04
WILLIAM HARVEY VENTED MEDIASTINAL DRAIN (K803037)C.R. Bard, Inc.1981-02-04
SWAN-GANZ VIP THERMODILUTION CATHETER (K810124)American Edwards Laboratories1981-02-04
IONESCU-SHILEY AORTIC GRAFT VALVE (K803000)Shiley, Inc.1981-02-02
SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS (K810079)3M Health Care, Sarns1981-01-30
ADULT ECG ELECTRODE #60-0724 (K810103)Aspen Laboratories, Inc.1981-01-29
INFANT ECG ELECTRODE #60-1029 (K810102)Aspen Laboratories, Inc.1981-01-29
ECG ARRHYTHMIA STIMULATOR (K810104)Belmont Instrument Corp.1981-01-29
SIEMENS-ELEMA MYOCARDIAL LEAD (K810036)Siemens Elema AB1981-01-29
PEDIATRIC ARTERIAL BLOOD FILTER (K810068)Delta Medical Industries1981-01-22
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