Atlas FDA

Cardiovascular

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

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RecordFirmDate
Warrior 14 guidewire (K180128)Vascular Solutions, Inc.2018-02-16
Prelude IDeal Hydrophilic Sheath Introducer (K173750)Merit Medical Systems, Inc.2018-02-15
CorPath GRX System (K173288)Corindus, Inc.2018-02-15
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter (K171933)Asahi Intecc Co., Ltd.2018-02-12
Jade PTA Balloon Dilatation Catheter (K173894)Orbusneich Medical Trading, Inc.2018-02-09
LUCAS 3 Chest Compression System (K173553)Jolife AB2018-02-08
PRESS DUO elite, PRESS DUO elite AG (K173450)Nemoto Kyorindo Co., Ltd.2018-02-07
AcQRef Introducer Sheath (K171557)Acutus Medical, Inc.2018-02-06
Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System (K173528)Devon Medical Products (Jiangsu), Ltd.2018-02-06
BETTERCARE PLATFORM - ADVANCED WEB CLIENT (K171361)Better Care S.L.2018-02-05
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter (K173672)Inari Medical2018-02-05
GORE Molding and Occlusion Balloon Catheter (K172567)W. L. Gore and Associates, Inc.2018-01-31
Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 (K172896)Shenzhen Jiacom Technology CO ., Ltd.2018-01-26
Essence 55S Large Monitor System (K172969)Shenyang Torch-Bigtide Digital Technology Co., Ltd.2018-01-26
MiCor A100 Wearable ECG Recorder (K162665)Mitac International Corp.2018-01-26
V2K Rinspiration System (K172716)V2k Medical, Inc.2018-01-26
SeQure® NF and SeQure® Microcatheters (K173430)Accurate Medical Therapeutics, Ltd.2018-01-26
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm (K173709)Inneuroco, Inc.2018-01-26
CliniCloud Stethoscope (K173448)Stethocloud Pty.Ltd (Clinicloud)2018-01-25
Gallant PTCA Dilatation Catheter (K173581)Medinol, Ltd.2018-01-25
Royal Flush Catheter (K171264)Cook Incorporated2018-01-25
Electrocardiograph (K171942)Edan Instruments, Inc.2018-01-24
CONTEC™ Electrocardiograph (K171360)Contec Medical Systems Co.,Ltd2018-01-22
Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile (K173235)Scientia Vascular, LLC2018-01-22
Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume (K173891)Vascular Solutions, Inc.2018-01-19
PulsioFlex Monitoring System (K172259)Pulsion Medical Systems SE2018-01-18
OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) (K173820)Boston Scientific Corporation2018-01-17
HI-TORQUE TurnTrac Guide Wire Family (K173795)Abbott Vascular2018-01-12
Microcatheter (K173560)Surmodics,Inc.2018-01-12
Automated ankle brachial pressure index measuring device (K172655)Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.2018-01-11
Microcatheter and guide-wire system (K171665)Suzhou Hengrui Disheng Medical Co., Ltd.2018-01-11
Digital Electrocardiograph (K171517)Biocare Bio-Medical Equipment Co., Ltd.2018-01-11
Amplatz Support Wire Guide with Apex Curve (K171445)Cook Incorporated2018-01-10
Digital Blood Pressure Monitor-Wrist Style (K171833)Shenzhen Combei Technology Co., Ltd.2018-01-10
Tempus Pro Patient Monitor (K173768)Remote Diagnostic Technologies , Ltd.2018-01-10
Epicardia Anywhere (K173170)Medicomp, Inc.2018-01-10
ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE (K173563)Tz Medical, Inc.2018-01-10
Roadrunner Extra Support Wire Guide (K171948)Cook Incorporated2018-01-05
EnsoETM (K172029)Attune Medical2018-01-05
ePatch (K171410)Braemar Manufacturing, LLC2018-01-04
WAVE Clinical Platform (K171056)Excel Medical Electronics, LLC2018-01-04
Attain Assist CS Access Catheter (K171819)Creganna Medical Also Doing Business AS Ceganna Tactx Medica2018-01-04
SOZO (K172507)ImpediMed Limited2017-12-22
Riptide Aspiration System (K172448)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2017-12-21
Elite HV Radial (K173287)Galt Medical Corp.2017-12-21
SafeSept Needle Free Transseptal Guidewire (K172893)Pressure Products Medical Device Manufacturing, LLC2017-12-21
Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design (K171275)Cook Incorporated2017-12-20
Peel-Away Introducer Set (K173685)Cook Incorporated2017-12-20
Sentrant Introducer Sheath with Hydrophilic Coating (K171866)Medtronic Vascular, Inc.2017-12-20
speX Support Catheter (K173662)Reflow Medical, Inc.2017-12-20
Reusable Blood Pressure Cuff (K171889)Suzhou Minhua Medical Apparatus Supplies Co., Ltd.2017-12-19
TBL-ABI System (K173696)Ld Technology, LLC2017-12-19
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter (K173618)Siemens Medical Solutions USA, Inc.2017-12-19
BioFlux Device (K172311)Biotricity, Inc.2017-12-15
FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile (K170029)International Biophysics Corporation2017-12-15
ECG Acquisition Systems (K163607)Vales & Hills Biomedical Tech. , Ltd.2017-12-15
PROTEUS PTA Balloon Catheter with Embolic Capture Feature (K172494)Angioslide, Ltd.2017-12-15
V10 (K170497)Mediana Co., Ltd.2017-12-15
The Nellcor pulse oximetry monitor interface cable (K172482)Covidien2017-12-15
Raider Guidewire (K173532)Vascular Solutions, Inc.2017-12-15
Advocate PTA Catheter (K173621)Merit Medical Systems, Inc.2017-12-13
True Flow Valvuloplasty Perfusion Catheter (K172932)C.R. Bard, Inc.2017-12-13
Disposable High Pressure Syringe (K170279)Union Medical Shenzhen Co., Ltd.2017-12-12
Cerebrotech CMS-5000 (K171186)Cerebrotech Medical Systems2017-12-08
CMS-2000 Central Monitoring System (K172966)Advanced Instumentations, Inc.2017-12-08
Lunderquist Extra Stiff Wire Guide (K171513)William Cook Europe Aps2017-12-07
091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm (K172468)Inneuroco, Inc.2017-12-06
PhotoFix Decellularized Bovine Pericardium (K172085)Cryolife, Inc.2017-12-04
ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath (K173470)Inari Medical2017-12-04
Octane aspiration system (K173266)Vascular Solutions, Inc.2017-12-01
Endophys Pressure Sensing Sheath Kit- 8F (K173399)Endophys Holdings, LLC2017-11-30
HeRO Graft (K172637)Merit Medical Systems, Inc.2017-11-30
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (K172687)Spectranetics, Inc.2017-11-27
Devon 51 (K172030)Devon Medical Products (Jiangsu), Ltd.2017-11-27
The Wrist-Type Fully Automatic Digital Blood Pressure Monitors (K170666)Joytech Healthcare Co. , Ltd.2017-11-22
TXM Hydrophilic Guidewire (K170915)Texasmedical Technologies, Inc.2017-11-21
Automatic Wrist Bluetooth Blood Pressure Monitor (K170545)Truly Instrument , Ltd.2017-11-21
TXM Support Catheter (K170914)Texasmedical Technologies, Inc.2017-11-21
Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath (K172995)Terumo Medical Corporation2017-11-21
Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface (K172984)Medtronic, Inc.2017-11-20
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff (K173044)Ningbo Albert Novosino Co., Ltd.2017-11-20
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (K172557)William Cook Europe Aps2017-11-20
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (K172584)William Cook Europe Aps2017-11-20
MR Wire Guide Wire Straight, MR Wire Guide Wire Angled (K173423)Nano4imaging GmbH2017-11-17
Duravess bovine pericardial vascular patch (K172660)Edwards Lifesciences, LLC2017-11-17
Langston dual lumen catheter (K170544)Vascular Solutions, Inc.2017-11-17
Performer Introducer (K173068)Cook Incorporated2017-11-17
Masimo Root Monitoring System and Accessories (K171121)Masimo Corporation2017-11-17
MC3 QuickFlow Dual Lumen Catheter (K171610)Mc3 Incorporated2017-11-16
Kardia Band System (K171816)AliveCor, Inc.2017-11-16
OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) (K173284)Boston Scientific Corporation2017-11-16
Intra.Ox Handheld Tissue Oximeter (K163472)Vioptix, Inc.2017-11-16
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) (K171901)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2017-11-15
Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter (K173289)Cook Incorporated2017-11-15
CXI TriForce Peripheral Crossing Set (K170931)Cook Incorporated2017-11-13
MX40 Release B.07 (K172226)Philips Medical Systems2017-11-09
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit (K172458)Smiths Medical Asd, Inc.2017-11-09
Odyssey Micro Catheter (K170664)Heraeus Medical Components, LLC2017-11-09
WATCHDOG Hemostasis Valve Kit (K172453)Boston Scientific Corporation2017-11-09
ulrichINJECT CT motion (K171392)Ulrich GmbH & Co. KG2017-11-09
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