Atlas FDA

Cardiovascular

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

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RecordFirmDate
ARROW JUGULAR PUNCTURE KIT 16 GA. (K820009)Arrow Intl., Inc.1982-01-22
MOD. 587 BLOOD PRESSURE & PULSE MONITOR (K813556)Bio Mega Diagnostic, Inc.1982-01-22
P.E.T. (K812793)Hospital Equipment Service1982-01-18
LPM/50 MEMBRANE OXYGENATOR (K813255)Travenol Laboratories, S.A.1982-01-18
HEMOSTATIC SIDE-ARM ADAPTER (K813578)Advanced Catheter Systems1982-01-18
APC IMPLANTABLE PACING LEAD (K812830)American Pacemaker Corp.1982-01-18
APC IMPLANTABLE PACING LEADS (K812807)American Pacemaker Corp.1982-01-18
PACE *AID (K813553)Cardiac Resucitator Corp.1982-01-18
CONTINUOUS FLUSH DEVICE (K813549)Namic1982-01-12
DINAMAP ADULT/PED./NEONATAL VITAL SIGNS (K813527)Critikon Company, LLC1982-01-12
IMPLANT AID SPLICING CRIMP & SLEEVE (K813518)Intermedics, Inc.1982-01-12
CARDIOSONIC ACOUSTIC AMPLIFIER (K813510)Srs Co.1982-01-12
MEDIFIX (K813498)Burron Medical Products, Inc.1982-01-07
DISPOSABLE TRANSDUCER (K813464)Sorensen Research1982-01-07
GERARD MEDICAL ELECTRODE TESTER (K813358)Gerard Medical Enterprises, Inc.1981-12-29
LINE POWERED LOW ENERGY DEFIBRILLATOR II (K813471)Narco Scientific1981-12-29
MEDIFIX GRADUATED SCALE (K813195)Burron Medical Products, Inc.1981-12-29
EAST WATER UNIT MARK 3 (K812955)Cairco , Ltd.1981-12-29
TELEMETRY TRANSMITTER & RECEIVER (K813064)Honeywell, Inc.1981-12-29
GEL ELECTRODE (K813176)Dyn-A-Med Products1981-12-29
KANTRON 504 HEARTSTATION (K812586)Kantron Cardiovascular, Inc.1981-12-29
MODEL 4200 ELLESTAD STRESS TEST ANALYZER (K813222)Del Mar Avionics1981-12-29
NARCO TELECARE ISOFLO PRESSURE MONITOR (K813502)Narco Bio-Systems1981-12-29
NIHON KOHDEN HEART MONITORS OMP 7101-02 (K813444)Nihon Kohden America, Inc.1981-12-29
OMED DISPOSABLE BULLDOG (K813499)Omega-Med Intl., Inc.1981-12-29
PERCUTANEOUS ENTRY NEEDLE, SELDINGER (K813461)Ocean Medical Products, Ltd.1981-12-29
EDSLAB CATHETER COVER (K813514)American Edwards Laboratories1981-12-29
THIGH CUFF: X-LARGE CUFF (K813323)Abco Dealers, Inc.1981-12-29
P51 ANGIOPLASTY PRESSURE TRANSDUCER (K813331)Konigsberg Instruments, Inc.1981-12-29
VITALOG PMS-8 MONITOR (K812739)Vitalog Corp.1981-12-29
MICRO-PREPROCESSOR UNIT (K812914)General Electric Co.1981-12-29
CARDIOINTEGRAM (K812971)Ocg Technology, Inc.1981-12-29
VENOUS CANNULA TRAY (K813284)Cunningham Woodland, Inc.1981-12-29
TEMPERATURE PROBES (K813271)Webster Laboratories, Inc.1981-12-29
BLOOD PRESSURE MONITOR (K812936)Amertek1981-12-14
FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-36 (K813021)Brentwood Instruments, Inc.1981-12-14
CC-201 ECG MONITORING SYSTEMS (K813287)Anthro-Metrics Corp.1981-12-14
DISPOSABLE DIAPHRAGM DOMES (K813267)Dio-Med Corp.1981-12-14
BOMED-NCCOM (K813020)Bomed Medical Mfr., Ltd.1981-12-14
VASCULAR PAWS (K813062)Sil-Med Corp.1981-12-14
TERUMO HOLLOW OXYGENATOR CIRCUIT (K812659)Terumo Medical Corp.1981-12-14
MICRO TRANSDUCER CATHETERS (K813125)Honeywell, Inc.1981-12-14
TERUMO HOLLOW FIBER OXYGENATOR (K812660)Terumo Medical Corp.1981-12-14
FLOWGUARD CATHETERS & CANNALAE (K813037)Advocacy International, Ltd.1981-12-14
ELECTROCARDIOGRAPH CM3000 (K813279)Philips Medical Systems (Cleveland), Inc.1981-12-14
IONESCU-SHILEY VALVE HOLDER & HANDLE (K813276)Shiley, Inc.1981-12-10
BIPOLAR OPTIMA MP #255 (K813079)Telectronics, Inc.1981-12-10
ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP (K813134)Telectronics, Inc.1981-12-10
SIEMENS-ELEMA PULSE GENERATOR 668 B (K812610)Siemens Corp.1981-12-10
ETHICON* TEMP. CARDIAC PACING WIRE (K813138)ETHICON, Inc.1981-12-10
POLY-FLEX PACING LEADS (K813028)Intermedics, Inc.1981-12-10
TEST MAGNET (K813153)Pacesetter Systems1981-12-02
L.O.N. DISPOSABLE CORONARY MANIFOLD (K812408)L.O.N. Research, Inc.1981-12-02
FUKUDA DENSHI CARDIMAX FK-12 (K813022)Brentwood Instruments, Inc.1981-12-02
CORREC TORR TM (K813137)Norton Performance Plastics Corp.1981-12-02
ELECTRODE TERMINAL CAP (K813152)Pacesetter Systems1981-12-02
ANERIOD GAUZE (K812932)Abco Dealers, Inc.1981-12-02
ADAPTING SLEEVE (K813154)Pacesetter Systems1981-12-02
FUKUDA DENSHI CARDIMAX FK-11 (K813023)Brentwood Instruments, Inc.1981-12-02
VITATRON INSERT (K813151)Pacesetter Systems1981-12-02
SIEMENS-ELEMA PSA 376 (K812104)Siemens Corp.1981-12-02
EVENT MASTER (K812920)Instruments For Cardiac Research1981-12-02
DIRECTIONAL BOOT (K813150)Pacesetter Systems1981-12-02
L.O.N. REUSABLE MANIFOLDS & STOPCOCKS (K812407)L.O.N. Research, Inc.1981-12-02
DESILET (K813143)Exco, Inc.1981-11-27
GEL ELECTRODE (K813013)Arndt Automation & Assoc.1981-11-27
EPC FILTER (K813123)Codman & Shurtleff, Inc.1981-11-27
CARDIOBEEPER MEMORY MONITOR (K813101)Survival Technology, Inc.1981-11-27
LEADER-CATH (K813142)Exco, Inc.1981-11-27
POLYSTAN VERTICLUDE BLOOD PUMP (K813035)Advocacy International, Ltd.1981-11-27
VYGON STOPCOCKS & RAMPS(MANIFOLDS) (K813141)Exco, Inc.1981-11-27
POLYSTAN HEART LUNG MACHINE SYS (K813034)Advocacy International, Ltd.1981-11-27
PACEPATH IMPLANT. ENDOCARD. PACING LEAD (K810286)Pacesetter Systems1981-11-27
INTERFACE ARTERIAL BLOOD FILTER (K813131)Medical, Inc.1981-11-27
ELECTRODE, PACEMAKER, PERMANENT (K810139)Pacesetter Systems1981-11-27
INTRAFLON, INTRAFLUX, INTRAVALVE (K813144)Exco, Inc.1981-11-27
VYGON EXTENSION TUBES & CONNECTORS (K813140)Exco, Inc.1981-11-27
COOLEY 2 VASCULAR PROSTHESIS STRAIGHT (K812248)Meadox Medicals, Div. Boston Scientific Corp.1981-11-24
MODEL 2000 MONITOR (K812828)Datascope Corp.1981-11-16
DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM (K813053)Bentley Laboratories, Inc.1981-11-16
FOGARTY FLEXIBLE PROBE (K812935)American Edwards Laboratories1981-11-16
SYNTHEMED PULSE GENERATOR VVI MODEL 1000 (K812464)Synthemed Corp.1981-11-16
DIAGNOSTIC MEDICAL COMPUTER (K812638)Diagnostic Resources, Inc.1981-11-16
INTRODUCER, PERCUTANEOUS SELDINGER (K812964)Triad Medical Division1981-11-16
INTERMEDICS POLYFLEX-MODEL 483-03 LEAD (K812990)Intermedics, Inc.1981-11-16
SKI 5000 (K812646)Smithkline Diagnostics, Inc.1981-11-16
ULTRA COM (K812209)Ultranamics, Inc.1981-11-16
PERCUTANEOUS INTRODUCER COURNAND STYLE (K812973)Dip, Inc.1981-11-16
INTERMEDICS POLYFLEX-MODEL 493-03 LEAD (K812989)Intermedics, Inc.1981-11-16
MILLAR MIKRO-TIP CATHETER PRESSURE TRAN. (K812944)Millar Instruments, Inc.1981-11-16
MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD (K812725)Medtronic Vascular1981-11-16
INTERMEDICS POLYFLEX-MODEL 483-04 LEAD (K812991)Intermedics, Inc.1981-11-16
PRUITT ARTERIAL OCCLUSION CHOLANG. CATH (K812111)Bionomy, Inc.1981-11-16
MODEL 535-03 TRACE A PACE (K812755)Intermedics, Inc.1981-11-16
PERCUTANEOUS INTRODUCER: SELDINGER STYLE (K813019)Dip, Inc.1981-11-16
PET POLYETHYLENE TORQUE CATHETER (K812999)Universal Medical Instrument Corp.1981-11-16
TRONZO HIP (K812946)Biomet, Inc.1981-11-06
MODEL 325C UNIPOLAR CARDIAC PULSE GEN. (K812832)Cook Pacemaker Corp.1981-11-05
TELECARE ISOTEC PRESSURE TRANSDUCER DOME (K812883)Narco Scientific1981-11-02
THE NEW 1600 ELECTRODE (K812878)Andover Medical, Inc.1981-11-02
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