Atlas FDA

Cardiovascular

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

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RecordFirmDate
HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR. (K871271)Huntleigh Technology, Inc.1987-09-15
PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860 (K872731)Ela Medical, Inc.1987-09-15
GUIDING CATHETER (K873004)Mallinckrodt Critical Care1987-09-15
OXIMETRY MODULE (K872626)Marquette Electronics, Inc.1987-09-15
SHEATH/DILATORS (K872724)Med-West, Inc.1987-09-15
LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW) (K871882)Lake Region Mfg., Inc.1987-09-15
COLIN'S MODEL APBM-630 AND QUINTON'S MODEL 470 (K872355)Colin Medical Instruments Corp.1987-09-15
THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 (K872529)American Edwards Laboratories1987-09-15
PERFUSION CATHETER (K872790)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-09-15
SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER (K872542)Angiomedics, Inc.1987-09-14
WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR (K872378)C.R. Bard, Inc.1987-09-14
AIS ANGIOSCOPE (K871492)Advanced Interventional Systems, Inc.1987-09-14
SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE (K872472)Angiomedics, Inc.1987-09-14
MOD 482 (K870850)Hoffrel Instruments, Inc.1987-09-08
MULTIPLE (K863387)Del Mar Avionics1987-09-04
CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 (K870804)American Bentley1987-09-01
HOLTER ST SYSTEM, MODEL NO. 5000-20 (K871389)Holter Data Services1987-09-01
CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 (K872167)American Bentley1987-09-01
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR (K872107)Minntech Corp.1987-08-28
CAVROPUMP (K871129)Life-Tech Intl., Inc.1987-08-28
CORONARY ARTERY BYPASS GRAFT (CABG) MARKER (K871110)Edward Weck, Inc.1987-08-27
5 MHZ TRANSDUCER (K872074)Sonicaid, Inc.1987-08-25
OXYGENATOR MODEL NO. BENTLEY 5 PLUS (K872133)American Bentley1987-08-24
ACS HI-TORQUE FLEX-T GUIDE WIRE (MODIFICATION) (K872220)Advanced Cardiovascular Systems, Inc.1987-08-21
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 (K865098)Telectronics, Inc.1987-08-18
ANDRIES PHYSICAL ASSESSMENT COMPUTER (K870545)Andries Tek, Inc.1987-08-14
MASCOT CW DOPPLER SYSTEM (K871212)Imex Medical Systems, Inc.1987-08-14
DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET (K872161)Shiley, Inc.1987-08-12
THE TELESCAN C.A.R.E. SYSTEM (K871587)Telescan Medical Systems1987-08-12
OLYMPUS ANGIOSCOPY PUMP (K871422)Olympus Corp.1987-08-12
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS (K871992)Telectronics, Inc.1987-08-12
DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES (K872159)Shiley, Inc.1987-08-12
DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY) (K870215)Cook, Inc.1987-08-12
CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) (K872485)Ideas For Medicine, Inc.1987-08-12
DOUBLE LUMEN CATHETER (K872248)Cordis Corp.1987-08-12
PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (K871080)Catheter Technology Corp.1987-08-12
TRANSCOR RADIO-STETHOSCOPE MB (K872234)Transcor, Inc.1987-08-11
QUANTASCOPE (K870442)Vital Science Corp.1987-08-11
SSD-725 ULTRASOUND SECTOR SCANNER (K870607)Ge Medical Systems Information Technologies1987-08-10
MEDTRONIC CLASSIX MODELS 8436/8437/8438 (K871866)Medtronic Vascular1987-08-10
CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEM (K870150)Cardio Metrics, Inc.1987-08-07
MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH (K872154)Ideas For Medicine, Inc.1987-08-03
ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE (K871441)Nitto Denko America, Inc.1987-08-03
ARGYLE VASCULAR BYPASS SET (K871844)Sherwood Medical Co.1987-08-03
CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS (K871774)Gish Biomedical, Inc.1987-08-03
SEAMED MODEL 3200 (K872551)Seamed Corp.1987-07-31
VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200) (K871418)Critikon Company, LLC1987-07-29
VITEL III, ECG TRANSMITTER (K872229)Equimed Corp.1987-07-29
MODIFIED DIGITAL BLOOD PRESSURE/PULSE METER (K872144)Vestra-Subco, Inc.1987-07-29
MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONIT (K871886)Draeger Medical, Inc.1987-07-29
MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER (K871720)A&D Engineering, Inc.1987-07-29
SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING (K871400)Ge Medical Systems Information Technologies1987-07-24
SERIES 2000 BEDSIDE PATIENT MONITOR (K872354)Marquette Electronics, Inc.1987-07-21
SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS. (K870916)Ge Medical Systems Information Technologies1987-07-21
SIRECUST MODEL 960 AND 961 PATIENT MONITORING (K872249)Medical Electronics Laboratories, Inc.1987-07-21
MODIFIED MODEL 9431 TELETRACE TRANSMITTER (K872246)Medtronic Vascular1987-07-21
SUPERMON NON-INVASIVE BLOOD PRESSURE MODULE 7282 (K861374)Kontron Instruments, Inc.1987-07-21
COMPANION 50 REGULATOR/FLOWMETER (K872443)Puritan Bennett Corp.1987-07-21
MINISTIK MINI PUNCTURE SET CATALOG CODE #57505 (K871137)Dlp, Inc.1987-07-16
HALL VEIN STRIPPER (K872157)Solco Basle, Inc.1987-07-07
MICOR (K865010)Siemens Medical Solutions USA, Inc.1987-07-06
LECTEC NON-INVASIVE PACING ELECTRODE (K872012)Lectec Corp.1987-06-29
NIGHTWATCH(TM) SYSTEM (K870578)Buckman Co., Inc.1987-06-29
DORCHES(TM) LIFESOUND(TM) (K870810)Centauri Manufacturing, Inc.1987-06-29
PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE (K871826)Datex Division Instrumentarium Corp.1987-06-29
HUNTLEIGH FLOWPAC FP2000 (K871272)Huntleigh Technology, Inc.1987-06-25
SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX (K863791)Gish Biomedical, Inc.1987-06-25
MODIFIED PACE*AID MODEL 53 (K871971)Cardiac Resucitator Corp.1987-06-24
PB240 PATIENT MONITOR/PULSE OXIMETER (K871864)Puritan Bennett Corp.1987-06-24
STAT-PAD (TM) (K871538)Cardiac Resucitator Corp.1987-06-24
MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER (K871718)A&D Engineering, Inc.1987-06-24
CATHETER INTRODUCER (K871153)Angeion Corp.1987-06-24
STAT-VAC CHEST DRAINAGE SYSTEM (K871775)Gish Biomedical, Inc.1987-06-24
MODEL 5600B PROGRAMMER, PACEMAKER (K871986)Telectronics, Inc.1987-06-24
PULSE/B.P. MONITOR (K864411)Pulse Time Products, Ltd.1987-06-24
J-CATH, GISH MODEL NO. JVAC-XXXX (K863790)Gish Biomedical, Inc.1987-06-24
MODEL 600 VASCULAR DUPLEX IMAGER (K863589)Multigon Industries, Inc.1987-06-24
FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM) (K871944)Futurecare Systems, Inc.1987-06-24
PREDICTOR (K871436)Corazonix Corp.1987-06-19
40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER (K864994)Aries Medical, Inc.1987-06-19
UMSC HOLTER MONITORING KIT (K872087)United Medical Supply Co., Inc.1987-06-19
40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER (K864537)Aries Medical, Inc.1987-06-19
EASY READ(TM) (K871794)Health O Meter1987-06-19
GEM-CRIT CHECK (K871686)Diamond Sensor Systems1987-06-18
GUIDING CATHETERS 9F JL4 (K871021)Devices For Vascular Intervention, Inc.1987-06-16
MODEL 617 CARDIAC OUTPUT COMPUTER (K870375)Omnimed B.V.1987-06-16
LP-3 ELECTROCARDIOGRAPH (K864614)Fidelity Medical, Inc.1987-06-16
IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) (K871596)Shiley, Inc.1987-06-15
CARDIO-MEGA SYSTEM (K871890)Grandcor Medical Systems1987-06-12
TATCH-IT (K870356)Reunion Medical Co.1987-06-12
PULSE CUFF RECORDER MODEL PCR100 (K863702)Imex Medical Systems, Inc.1987-06-12
DIGITAL SPHYGMOMANOMETER (K871371)Omron Tateisi Electronics Co.1987-06-12
DS-II DIGITAL SONOGRAPHY SYSTEM (K864278)Intl. Acoustics, Inc.1987-06-10
MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543 (K871915)Pace Medical1987-06-10
THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE (K871748)The Buddy Systems, Inc.1987-06-10
BIODAN TYPE COMET ELECTRODE (K871668)National Medical Technology1987-06-10
BUBBLE TRAP CAT. NO. B-180 (K870819)American Omni Medical, Inc.1987-06-08
OXIMETER (K871353)Radiometer America, Inc.1987-06-08
PREBYPASS FILTER (K871350)American Omni Medical, Inc.1987-06-08
BOWEN REUSEABLE/DISPOSABLE ELECTRODE (K871325)Bowen & Company, Inc.1987-06-08
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