Atlas FDA

Cardiovascular

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

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RecordFirmDate
OLYMPUS RETRACTABLE VALVULOTOME (K911702)Olympus Corp.1991-12-27
MODEL HD-207 BIDIRECTIONAL VELOCITY METER (K912409)Koven and Assoc., Inc.1991-12-23
DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION (K914985)E-Z-Em, Inc.1991-12-20
MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST (K913358)Ppg Industries, Inc.1991-12-20
SOS BLOODLESS NEEDLE (K914330)E-Z-Em, Inc.1991-12-20
CARDIOVASCULAR REPAIR PATCH (K905073)Impra, Inc.1991-12-20
CUSTOM TUBING PACKS (K913363)Kroy Medical, Inc.1991-12-20
MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST (K914974)Medtronic Vascular1991-12-19
AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS (K912588)Sein Electronics Co., Ltd.1991-12-19
ANGIOGRAPHIC SOFT TIP CATHETER (K914199)E-Z-Em, Inc.1991-12-18
CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COAT (K914863)Cordis Corp.1991-12-18
EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE (K911320)Applied Biometrics, Inc.1991-12-18
DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVE (K914422)Devices For Vascular Intervention, Inc.1991-12-18
MERIT DISPOSAL DEPOT(TM) (K914208)Merit Medical Systems, Inc.1991-12-18
CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES (K913691)Gish Biomedical, Inc.1991-12-18
CORDIS BIPAL BIOPSY FORCEPS (K914567)Cordis Corp.1991-12-18
ZOLL D-900 DEFIBRILLATOR (K913484)Zmi Corp.1991-12-16
FEMORAL ARTERY PRESSURE PAD/DISK (K914149)Disco, Inc.1991-12-13
ONTRAC (K914138)Lake Region Mfg., Inc.1991-12-13
MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 (K912446)Vasamedics, LLC1991-12-12
ITC HIESHIMA TAPER SELECT(TM) PERCUTANEOUS CATH (K912532)Interventional Therapeutics Corp.1991-12-11
RETRIEVAL DEVICE (K914067)Target Therapeutics1991-12-10
ORG-8200A UNIVERSAL SIGNAL HOUSING (K912744)Nihon Kohden America, Inc.1991-12-09
ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION (K914458)Medical Data Electronics1991-12-09
SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER (K914009)Schneider Intl., Ltd.1991-12-06
MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR (K914762)Micromed1991-12-05
SYSTEM ATHENA - PRODUCT ENHANCEMENTS (K912049)S & W Medico Teknik1991-12-05
REMOVE LABELING RESTRICT FROM GUIDE WIRES (K912293)Target Therapeutics1991-12-05
SAFE II (K912082)Polystan A/S1991-12-04
MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF (K914742)Medtronic Vascular1991-12-04
TYPE 9210 S/ECG (K903940)S & W Medico Teknik1991-12-04
DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 (K912188)Critikon Company, LLC1991-12-04
TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION (K914971)Nihon Kohden America, Inc.1991-12-04
DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER (K911883)Diag Corp.1991-11-29
CONNECTING SET (K914128)Procedure Products, Inc.1991-11-27
BARD(R) BIOPOTENTIAL AMPLIFIER II (K913875)Bard Electrophysiology1991-11-27
VESSEL DILATOR (K913027)Deseret Medical, Inc.1991-11-27
PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION (K914116)Medtronic Vascular1991-11-27
FLOSWITCH(R) HP (K913871)Boston Scientific Corp1991-11-25
ITC GUIDING CATHETER (K913052)Interventional Therapeutics Corp.1991-11-22
TARGET THERAPEUTICS RADIOPAQUE STYLET (K914001)Target Therapeutics1991-11-22
MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES (K914460)Medtronic Vascular1991-11-22
DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED (K914602)The Heart Valve Div. Medtronic Cardiovascular Surg1991-11-22
CORDIS OBTURATOR (K914352)Cordis Corp.1991-11-22
SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS (K913830)Scimed Life Systems, Inc.1991-11-22
SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS (K914312)Scimed Life Systems, Inc.1991-11-22
MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER (K913805)Pace Medical1991-11-19
ES1600 PARAMEDIC TELEPHONE (K912281)Epic Systems, Inc.1991-11-19
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG (K913827)Hewlett-Packard Co.1991-11-19
MERIT CUSTOM KIT (K913682)Merit Medical Systems, Inc.1991-11-15
VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) (K913692)Bentley Laboratories, Inc.1991-11-15
VITALMAX 510/520 (K912880)Pace Tech, Inc.1991-11-14
NELLCOR(R) N-180 PULSE OXIMETER (K913695)Nellcor, Inc.1991-11-13
THE BIG EASY Y-ADAPTER (K914046)Microvena Corp.1991-11-08
STETHOSCOPE (K914100)Atlas Medical Products, Inc.1991-11-07
MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS) (K913533)Hewlett-Packard Co.1991-11-07
TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY (K912404)Hewlett-Packard Co.1991-11-07
CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS (K911871)Cardiodyne, Inc.1991-11-07
DELPHIN II CENTRIFUGAL SYSTEM (K913176)3M Health Care, Sarns1991-11-07
VASCUMAP MEDICAL AIR PLETHYSMOGRAPH (K914200)Carolina Medical Electronics1991-11-07
AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR (K913523)Omron Healthcare, Inc.1991-11-06
DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON (K910997)Datascope Corp.1991-11-05
Q4500 STREE TEST MONITOR (K910017)Quinton, Inc.1991-11-05
GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE (K914447)W. L. Gore & Associates, Inc.1991-11-05
ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION (K912477)Interventional Therapeutics Corp.1991-11-05
COORDINATOR, CABLE INPUT (K914725)Cardiotronics, Inc.1991-11-05
0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE (K913074)Terumo Medical Corp.1991-11-05
GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE (K914448)W. L. Gore & Associates, Inc.1991-11-05
TEGWIRE (TM) (K913391)Boston Scientific Corp1991-11-05
GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE (K914450)W. L. Gore & Associates, Inc.1991-11-05
TORQUE FITTING (K912969)Freedom Machine, Inc.1991-11-05
ISOLATE INFUSION CATHETR SYSTEM (K913517)Lake Region Mfg., Inc.1991-11-05
MODEL 520A NOVAMETRIX PULSE OXIMETER (K913516)Novametrix Medical Systems, Inc.1991-11-04
MEGA ANGIOGRAM KIT (K913397)Mega Medical, Inc.1991-10-31
SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION (K911761)S & W Medico Teknik1991-10-31
HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS (K913451)Hewlett-Packard Co.1991-10-31
QR-50-E DISPOSABLE RADIOTRANSLUCENT ECG ELECTRODE (K914672)Medicotest, Inc.1991-10-31
TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST (K912045)Lifestream Int'L, Inc.1991-10-31
SIEMENS MICRO2 PULSE OXIMETER (K913489)Siemens Medical Electronics1991-10-30
SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF (K912604)Aries Medical, Inc.1991-10-28
ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR (K911965)Citizen Watch Co., Ltd.1991-10-28
.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE (K913631)Advanced Cardiovascular Systems, Inc.1991-10-28
DAIG FAST CATH(TM) INTRODUCER, MODIFICATION (K914090)Daig Corp.1991-10-28
TORQUE TUBE STEEROCATH(TM) (K913375)Ep Technologies, Inc.1991-10-25
CIBA CORNING MODEL 270 CO-OXIMETER (K913332)Ciba Corning Diagnostics Corp.1991-10-23
BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER (K913734)Augustine Medical, Inc.1991-10-23
.010 HI-TORQUE PLUS(TM) GUIDE WIRE (K913328)Advanced Cardiovascular Systems, Inc.1991-10-23
SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY (K912079)3M Health Care, Sarns1991-10-23
HEPARIN COATED THERMODILUTION CATH & ACCESSORIES (K911710)Sunscope Intl., Inc.1991-10-23
VASCULAR GUIDE WIRE (K913353)Advanced Cardiovascular Systems, Inc.1991-10-23
CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER (K914141)Cordis Corp.1991-10-23
UNIPOLAR UPSIZING ADAPTOR (K912773)Telectronics Pacing Systems, Inc.1991-10-23
OCHSNER ULP BIFURCATION VASCULAR PROTHESIS (K913143)Intervascular, Inc.1991-10-23
MERIT MANIFOLD (K913161)Merit Medical Systems, Inc.1991-10-21
CORDIS PTCA GUIDING CATHETER, MODIFICATION (K913783)Dow Corning Wright1991-10-18
CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH (K914007)Cordis Corp.1991-10-18
ANNULUS VALVULOTOME (K912636)Cardio Source1991-10-18
ANNULUS DISPOSABLE VALVULOTOME (K912635)Cardio Source1991-10-18
SIMON NITINOL FILTER, MODIFICATION (K912144)Nitinol Medical Technologies, Inc.1991-10-17
MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS (K913288)Medtronic Vascular1991-10-17
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