Atlas FDA

Cardiovascular

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

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RecordFirmDate
SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461 (K896671)3M Company1990-02-14
LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2 (K896515)Tsi, Inc.1990-02-13
MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION (K895793)Del Mar Avionics1990-02-13
CARDIOPULMONARY SUPPORT (CPS) SYSTEM (K892664)Bard Cardiosurgery Div1990-02-13
THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH. (K896597)Boston Scientific Corp1990-02-12
MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER (K894543)Del Mar Avionics1990-02-08
SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME (K896466)Baxter Healthcare Corp1990-02-08
PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA (K895136)Medtronic Vascular1990-02-08
HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM (K896435)Hewlett-Packard Co.1990-02-07
MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES (K897067)Telectronics Pacing Systems, Inc.1990-02-05
CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520 (K896972)Daily Medical Products, Inc.1990-02-05
CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420 (K896971)Daily Medical Products, Inc.1990-02-05
PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI (K896430)Datascope Corp.1990-02-05
CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320 (K896973)Daily Medical Products, Inc.1990-02-05
CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 (K896974)Daily Medical Products, Inc.1990-02-05
CIRCAMED HOLTER VERSION 4 (K894956)Circadian, Inc.1990-02-05
CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220 (K896975)Daily Medical Products, Inc.1990-02-05
ACS GOLD SERIES ELASTINITE GUIDE WIRE (K896379)Advanced Cardiovascular Systems, Inc.1990-02-02
CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620 (K896393)Daily Medical, Inc.1990-02-02
AUTO-CUFF(TM) (K896633)U.S. Medical Corp.1990-02-01
FUKUDA DENSHI MODEL DS-3300 ETR (K897063)Fukuda Denshi USA, Inc.1990-02-01
VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN (K896414)Baxter Healthcare Corp1990-01-31
NKA MODELS AB-601G AND AB-621G (K900272)Nihon Kohden America, Inc.1990-01-31
ANGIOSCOPY PUMP (K895074)Baxter Healthcare Corp1990-01-31
GENESIS III, (MOD. 7003/7004) (K894370)Biosound, Inc.1990-01-29
LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER (K895533)Matrix Medica, Inc.1990-01-26
MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR (K896809)Medtronic Vascular1990-01-26
JOBST ATHROMBIC PUMP(R) SYSTEM 2000 (K895732)Jobst Institute, Inc.1990-01-26
HPD TUBING CONNECTORS (K895795)Hpd Medical, Inc.1990-01-26
MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER (K895525)Matrix Medica, Inc.1990-01-26
TYPE 9541 RECORDER, PAPER CHART (K895111)S & W Medico Teknik1990-01-26
EXPANSION OF THE CORDIS PTA DILATATION CATHETER (K894899)Cordis Corp.1990-01-26
SFA MODULE (K896528)Life Sciences Manufacturing, Inc.1990-01-26
MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE (K900169)Laerdal Mfg. Corp.1990-01-26
WR3500 AND WR3600 SERIES RECORDERS (K894922)Western Graphtec1990-01-26
SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283 (K882955)Kontron Instruments, Inc.1990-01-26
AMBULATORY CARDIAC MONITOR (K896064)Monitech, Inc.1990-01-26
AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED (K895266)Biosensor Corp.1990-01-26
MODIFIED ANGIOGRAPHIC CATHETER (K896690)Novoste Corp.1990-01-24
MILLAR MIKRO-TIP DOPPLER CATHETER (K896264)Millar Instruments, Inc.1990-01-24
MODEL EC4542G MINIATURE (K896352)Pace Medical1990-01-24
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION (K896819)Baxter Healthcare Corp1990-01-19
DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF (K896788)Advanced Medical Instruments, Inc.1990-01-19
B-D ANGIOGRAPHIC CONTROL SYRINGE (K895318)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-01-19
INSULATION PAD (K896307)Bio-Vascular, Inc.1990-01-19
NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW. (K894631)Nihon Kohden America, Inc.1990-01-19
USCI PRESTO DISPOSABLE INFLATION DEVICE (K896415)C.R. Bard, Inc.1990-01-19
CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER (K896002)Instromedix, Inc.1990-01-19
MEDISEAL SUCTION CANISTER (K895427)Deroyal Industries, Inc.1990-01-19
MODIFIED DR-2C/PMC 100 (K896153)General Devices1990-01-19
BALLOON DILATATION CATHETER (K894944)Peripheral Systems Group1990-01-19
GUIDING CATHETER (K895146)Peripheral Systems Group1990-01-19
DEFIB K-PADS (K895662)Katecho, Inc.1990-01-18
MEDILOG OPTIMA (K896535)Oxford Medilog, Inc.1990-01-18
PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM (K896034)D. E. Hokanson, Inc.1990-01-18
CARDIOPHONE (K894856)Euro-American Marketing Group, Inc.1990-01-18
MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR (K896102)Advanced Medical Products, Inc.1990-01-18
ASTRO-MED ASC-951 PRESSURE PROCESSOR (K894295)Astro-Med, Inc.1990-01-18
FIVE-YEAR STERILE PACKAGING SHELF LIFE (K892528)Daig Corp.1990-01-18
POLYSTAN HEATER-COOLER UNIT (K893940)Polystan C/O Vitalcor, Inc.1990-01-18
MIDA SYSTEM, MODELS 1000/1100 (K896396)Medical Graphics Corp.1990-01-18
KALOS 05 PULSE GENERATOR (K896184)Biotronik Cardiac Pacemakers1990-01-18
MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR (K896103)Advanced Medical Products, Inc.1990-01-18
ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC. (K896569)Jason Marketing Co.1990-01-18
THE PILOT SCIMED TORQUE DEVICE (K896108)Scimed Life Systems, Inc.1990-01-09
MODEL DS-3300 DYNASCOPE PATIENT MONITOR (K894628)Fukuda Denshi USA, Inc.1990-01-08
IVT 0.014 GUIDE WIRE (K895903)Intensive Technology, Inc.1990-01-04
MODEL MC6500 ELECTROCARDIOGRAPH (K895961)Cambridge Medical Instruments, Inc.1990-01-04
PSG(TM) EDM(TM) INFUSION CATHETER (K895932)Peripheral Systems Group1990-01-04
OLYMPUS VALVULOTOME W/DETACHABLE TIP (K895878)Olympus Corp.1990-01-02
MULTILUMEN CENTRAL VENOUS CATHETER (K885221)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-28
VOSS VEIN CLAMP (K885161)Voss Medical Products1989-12-22
SAFE-1 (K893704)Polystan C/O Vitalcor, Inc.1989-12-22
SAFE-1 VENOUS RESERVOIR (K893705)Polystan C/O Vitalcor, Inc.1989-12-22
MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS (K896443)Possis Medical, Inc.1989-12-20
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T (K895447)Pacesetter Systems1989-12-20
NKA MODEL SEC-3102 CARDIAC STIMULATOR (K894492)Nihon Kohden America, Inc.1989-12-20
INFLATION PRO II (K895836)Baxter Healthcare Corp1989-12-20
BIOCHEM 3100 OXIMETER (K893877)Biochem International, Inc.1989-12-20
MT96000 PAPER CHART RECORDER (K894736)Astro-Med, Inc.1989-12-13
RED DOT CARDIAC SENSOR SYSTEM (K896155)3M Company1989-12-13
GEL-TAC(R) (K895009)Padeco, Inc.1989-12-13
PE INTERCARDIAC MAPPING SYSTEM (ICMS) (K895916)Prucka Engineering, Inc.1989-12-13
MEDTRONIC MODEL 5401B TEST CABLE (K896632)Medtronic Vascular1989-12-13
VASCULAR CLAMP (K895691)Applied Vascular Devices, Inc.1989-12-13
MINIMON 7133B PATIENT MONITOR (K896386)Kontron Instruments, Inc.1989-12-13
DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB. (K894356)Phycon1989-12-13
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380 (K895632)3M Company1989-12-12
KONTRON KOLORMON 7250 PATIENT MONITOR (K896417)Kontron Instruments, Inc.1989-12-12
MARQUETTE 1200 DEFIBRILLATION PADS (K895651)Marquette Electronics, Inc.1989-12-12
ZYMED MODEL 1610 (K895208)Agilent Technologies1989-12-12
DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT. (K894355)Phycon1989-12-12
CLOSED CHEST SUPPORT CIRCUIT (K893207)Medtronic Blood Systems, Inc.1989-12-12
UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490 (K895789)Medtronic Vascular1989-12-07
CATHETER, CARDIOVASCULAR, BALLOON TYPE (K883852)Wb Intl., Inc.1989-12-07
RMI CARDIOPLEGIA DELIVERY SETS (K892368)Research Medical, Inc.1989-12-07
RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET (K892377)Research Medical, Inc.1989-12-07
MILLAR MIKRO-TIP PULSE TRANSDUCER (K895721)Millar Instruments, Inc.1989-12-07
ECG SIMULATOR MODEL ECGPLUS (K893660)Bio-Tek Instruments, Inc.1989-12-05
MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM (K891121)Boston Scientific Corp1989-12-05
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