Atlas FDA

Cardiovascular

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

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RecordFirmDate
TUBING FOR CARDIOPULMONARY BYPASS (K833112)Cardio Med Supplies, Inc.1983-11-28
PROTECTIVE SLEEVE (K832380)Vertex Medical Corp.1983-11-28
ELECTROCARDIOCORDER RECORDER 453 (K833661)Del Mar Avionics1983-11-28
SERVOMED BASIC BEDSIDE UNIT SMVIII W (K831781)Litton Medical Electronics1983-11-16
SERVOMED BASIC BEDSIDE UNIT SMV 104 (K831783)Litton Medical Electronics1983-11-16
SERVOMED COMPACT MONITOR SMK 155-9 (K832035)Litton Medical Electronics1983-11-16
SERVOMED SMC 108/111-426-24, 111-426 (K832022)Litton Medical Electronics1983-11-16
SERVOMED CENTRAL STATION SMV 206 (K832131)Litton Medical Electronics1983-11-16
SERVOMED BASIC BEDSIDE UNIT SMV 107 (K831782)Litton Medical Electronics1983-11-16
SERVOMED COMPACT MONITOR SMK 154-8/101 (K832021)Litton Medical Electronics1983-11-16
PACEMAKER SYS. ANALYZER 378 (K832959)Siemens Elema AB1983-11-14
DIGITAL INJECTOR SYS (K833138)Sybron Corp.1983-11-14
SINGLE BED ARRHYTHMIA MONITOR AM500 (K831638)Lifeline Systems, Inc.1983-11-14
PRIMA-UNIPOLAR CARDIAC PULSE GENERAT (K832914)Intermedics, Inc.1983-11-14
BP TRANSDUCER HOLDERS TH-2,3 & 4 (K832384)American Bentley1983-11-14
CASE-II (K833458)Marquette Electronics, Inc.1983-11-14
PHOENIX 60/60 PROCESSOR MODULE (K831134)Phoenix Corp.1983-11-07
DISPOSABLE MANIFOLD SET (K832657)Mallinckrodt Critical Care1983-11-07
DINAMAP VITAL SIGNS MONITOR #1846P (K832656)Critikon Company, LLC1983-11-07
PACEMAKER EVALUATION MODULE-330 (K833470)Marquette Electronics, Inc.1983-11-07
ARRHYTHMIA III CARDULE #1919 (K832693)Spacelabs, Inc.1983-11-07
CORPULS 300 (K832827)Automated Medical Products, Inc.1983-11-03
TRANSDUCER DOME SD105 (K833095)Sorensen Research1983-11-03
THERMAL DILUTION CATHETER (K832324)Catheter Corp. of America1983-11-03
PORTABLE DEFIBRILLATOR MONITOR 74DRK (K831696)Honeywell, Inc.1983-11-03
TRANSDUCER DOME DS106 (K833096)Sorensen Research1983-11-03
TRANSDUCER DOME SD104 (K833094)Sorensen Research1983-11-03
SATURN-24HR. HOLTER SCANNER (K832772)Hittman Medical Systems1983-11-03
PECOR 8.5 FRENCH IAB ON A DATASCOPE (K831307)Datascope Corp.1983-11-02
FRENCH INTRA-AORTIC 9.5 BALLOON ON KON (K831397)Datascope Corp.1983-11-02
SIMPLISCRIPTOR EK 31/101 037 16 (K832184)Litton Medical Electronics1983-10-31
LME BLOOD PRESSURE MONITOR (K832017)Litton Medical Electronics1983-10-31
LME PATIENT MONITOR SMS 151 (K832013)Litton Medical Electronics1983-10-31
MULTISCRIPTOR EK 36/101 047 02,05 (K832130)Litton Medical Electronics1983-10-31
PATIENT MONITOR #RM-100 (K831817)Honeywell, Inc.1983-10-31
MULTISCRIPTOR EK VARIOUS #43 (K832015)Litton Medical Electronics1983-10-31
MEDICAL ELECTRONICS-PRINTER CLOCK (K832012)Litton Medical Electronics1983-10-31
CENTRAL STATION MONITOR CSM-100 (K831818)Honeywell, Inc.1983-10-31
MULTISCRIPTOR EK #403 VARIOUS MODEL (K832014)Litton Medical Electronics1983-10-31
VENOUS RESERVOIR (K832924)Shiley, Inc.1983-10-31
SERVOMED COMPACT MONITOR 181/10105002 (K832018)Litton Medical Electronics1983-10-31
CRITIKON CARDIAC OUTPUT COMPUTER (K831967)Critikon Company, LLC1983-10-28
SILICONE RUBBER ISOLATION SLEEVE 350-01 (K833199)Intermedics, Inc.1983-10-28
GENERATOR, PULSE, PACEMAKER #532 (K831860)Vitatron Medical BV1983-10-27
SILICONE RUBBER ISOLATION SLEEVE 351-01 (K833198)Intermedics, Inc.1983-10-27
WLECTROCARDIOGRAPH ECG-7204 (K831274)Nihon Kohden America, Inc.1983-10-27
PACEMAKER PROGRAMMER #2032 (K831859)Vitatron Medical BV1983-10-27
SERVOMED BASIC BEDSIDE UNIT SMS 108 W/ (K832026)Litton Medical Electronics1983-10-26
SERVOMED STANDARD SMS 104 (K832041)Litton Medical Electronics1983-10-26
LME HEART-RATE MONITOR (K832016)Litton Medical Electronics1983-10-26
SERVOMED BASIC BEDSIDE UNIT - VARIOUS (K832024)Litton Medical Electronics1983-10-26
MGI STRENGTH/FITNESS SYS-MODEL #PU-101 (K832528)Mgi Strength/Fitness Systems, Inc.1983-10-20
BLOOD OXYGENATOR 5070 (K831894)Shiley, Inc.1983-10-20
HYPOTHERMIC MYCARDIAL PROTECTION DEV (K832417)3M Health Care, Sarns1983-10-20
ULTRA LIGHT RAAF CATHETER (K832784)Quinton, Inc.1983-10-20
CARDIOPLEGIA RECIRCULATION SYS-BL 705/A (K831458)Electromedics, Inc.1983-10-20
PHYSIOLOGICAL PRESSURE MEASUREMENT CATH (K832604)Camino Laboratories, Inc.1983-10-20
MULTIPOLAR TEMPORARY CARDIAC (K831804)Oscor, Inc.1983-10-20
HOLTA-MED RECORDER (K832395)Holta-Med1983-10-20
LEAD INTRODUCER SETS-EB-S8 & EB-S12 (K831751)Oscor, Inc.1983-10-20
TEMP. CARDIAC PACING WIRE TME 60/61/65 (K831695)Oscor, Inc.1983-10-20
PERMANTHANE #866 BIPOLAR COAXIAL (K832987)Pacesetter Systems1983-10-20
PURGES LINES, PL-45 & PL-33 (K833048)American Bentley1983-10-20
IMPLANTABLE ENDOCARDIAL PACING LEADS (K831997)Oscor, Inc.1983-10-20
PHYSIOLOGICAL PRESS. MEASUREMENT CATH (K832579)Camino Laboratories, Inc.1983-10-20
USCI ANGIOGRAPHIC BALLOON CATHETER (K831854)C.R. Bard, Inc.1983-10-20
BIOTRONIK DFH UNIPOLAR PE-60/4-DFH (K833106)Biotronik Sales, Inc.1983-10-20
BIOTRONIK N, BIPOLAR PEB-60/4-N (K833099)Biotronik Sales, Inc.1983-10-20
BLOOD OXYGENATOR 50 70/S (K831895)Shiley, Inc.1983-10-19
PERCLUDER DL OCCLUDING BALLOON (K832386)Datascope Corp.1983-10-19
IONESCU-SHILEY LOW POROSITY COMPOSITE (K831865)Shiley, Inc.1983-10-19
BIOTRONIK DN UNIPOLAR PE-60/4-DN & (K833098)Biotronik Sales, Inc.1983-10-19
ELECATH PACEWEDGE DUAL PRESS. BIPOLAR (K832850)Electro-Catheter Corp.1983-10-19
BIOTRONIK D2K UNIPOLAR PE-60/4 (K833104)Biotronik Sales, Inc.1983-10-19
VIDEO-DILUTION TECH. MARK I INSTRUMENT (K831057)Angio Tec Corp.1983-10-19
ACCU-SPHYG (K832060)Olympic Medical Corp.1983-10-19
BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC (K833101)Biotronik Sales, Inc.1983-10-19
TAYLOR PRINTER/AUTO INFLAT-SPHYGMOMANO (K831245)Ritter Co.1983-10-19
NOVA BALLOON THERMODILUTION INFUSION (K832287)Nova Medical Specialties1983-10-19
PATIENT MONITOR 788 33A (K831943)Hewlett-Packard Co.1983-10-19
BIOTRONIK I-UNIPOLAR PE-60/2-13 (K833108)Biotronik Sales, Inc.1983-10-19
IONESCU-SHILEY LOW POROSITY AORTIC GRAFT (K831880)Shiley, Inc.1983-10-19
TOP THREE WAY STOPCOCK (K832625)Top Surgical Manufacturers Co.1983-10-19
AXIOM PERFUSSION CANNULA (K832475)Axiom Medical, Inc.1983-10-19
PATIENT MONITOR #78832A (K831944)Hewlett-Packard Co.1983-10-19
EPCOR MULTIELECTRODE TEMP. PERVENOUS (K832561)Cordis Corp.1983-10-19
CARDIAC OUTPUT COMPUTER (K831407)Ziehm International, Inc.1983-10-14
AS 191 ECG TELEMETRY MODULE (K831429)Narco Scientific1983-10-14
AS 1740 INTERFACE MODULE (K831428)Narco Scientific1983-10-14
PATIENT SELECTOR FUNCTION BLOCK (K832212)Honeywell, Inc.1983-10-14
QUANTUM BIPOLAR CARDIAC PULSE GENERATOR (K831633)Intermedics, Inc.1983-10-12
MODEL 329T PROGRAMMABLE, BIPOLAR CARDI (K832893)Cook Pacemaker Corp.1983-10-04
SELF CHECK DIGITAL BLOOD PRESS. MONITOR (K832171)Ritter Co.1983-10-04
DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN (K831481)Eugene Scarberry1983-10-04
SHILEY GAS FILTER (K832704)Shiley, Inc.1983-09-29
FOGARTY 6MM SOFTJAW CLIP (K832554)American Edwards Laboratories1983-09-29
PATIENT MONITOR #78353A (K831787)Hewlett-Packard Co.1983-09-29
FOGARTY-CHIN PERIPHERAL DILATION CATH (K832474)American Edwards Laboratories1983-09-29
CARDIO-SCOPE MINI MONITOR (K831878)W.E. Leder Enterprises, Inc.1983-09-29
SHILEY MULTIPRO CATHETER (K832044)Shiley, Inc.1983-09-29
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