FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
2617–2640 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 09, 2018
Jade PTA Balloon Dilatation Catheter
K173894 · LIT
Orbusneich Medical Trading, Inc.
Cardiovascular · 50d
Cleared Feb 08, 2018
LUCAS 3 Chest Compression System
K173553 · DRM
Jolife AB
Cardiovascular · 84d
Cleared Feb 07, 2018
PRESS DUO elite, PRESS DUO elite AG
K173450 · DXT
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 93d
Cleared Feb 06, 2018
Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System
K173528 · JOW
Devon Medical Products (Jiangsu), Ltd.
Cardiovascular · 83d
Cleared Feb 06, 2018
AcQRef Introducer Sheath
K171557 · DYB
Acutus Medical, Inc.
Cardiovascular · 252d
Cleared Feb 05, 2018
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter
K173672 · QEW
Inari Medical
Cardiovascular · 67d
Cleared Feb 05, 2018
BETTERCARE PLATFORM - ADVANCED WEB CLIENT
K171361 · MWI
Better Care, S.L.
Cardiovascular · 272d
Cleared Jan 31, 2018
GORE Molding and Occlusion Balloon Catheter
K172567 · MJN
W. L. Gore and Associates, Inc.
Cardiovascular · 159d
Cleared Jan 26, 2018
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
K173709 · DQY
Inneuroco, Inc.
Cardiovascular · 53d
Cleared Jan 26, 2018
SeQure® NF and SeQure® Microcatheters
K173430 · DQO
Accurate Medical Therapeutics, Ltd.
Cardiovascular · 85d
Cleared Jan 26, 2018
Essence 55S Large Monitor System
K172969 · DXJ
Shenyang Torch-Bigtide Digital...
Cardiovascular · 122d
Cleared Jan 26, 2018
Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A,...
K172896 · DXN
Shenzhen Jiacom Technology CO ., Ltd.
Cardiovascular · 126d
Cleared Jan 26, 2018
V2K Rinspiration System
K172716 · QEW
V2k Medical, Inc.
Cardiovascular · 140d
Cleared Jan 26, 2018
MiCor A100 Wearable ECG Recorder
K162665 · DPS
Mitac International Corp.
Cardiovascular · 487d
Cleared Jan 25, 2018
Gallant PTCA Dilatation Catheter
K173581 · LOX
Medinol, Ltd.
Cardiovascular · 66d
Cleared Jan 25, 2018
CliniCloud Stethoscope
K173448 · DQD
Stethocloud Pty.Ltd (Clinicloud)
Cardiovascular · 80d
Cleared Jan 25, 2018
Royal Flush Catheter
K171264 · DQO
Cook Incorporated
Cardiovascular · 269d
Cleared Jan 24, 2018
Electrocardiograph
K171942 · DPS
Edan Instruments, Inc.
Cardiovascular · 210d
Cleared Jan 22, 2018
Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm,...
K173235 · DQX
Scientia Vascular, LLC
Cardiovascular · 109d
Cleared Jan 22, 2018
CONTEC™ Electrocardiograph
K171360 · DPS
Contec Medical Systems Co.,Ltd
Cardiovascular · 258d
Cleared Jan 19, 2018
Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2...
K173891 · KRD
Vascular Solutions, Inc.
Cardiovascular · 29d
Cleared Jan 18, 2018
PulsioFlex Monitoring System
K172259 · DXG
Pulsion Medical Systems SE
Cardiovascular · 175d
Cleared Jan 17, 2018
OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD,...
K173820 · OBJ
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jan 12, 2018
HI-TORQUE TurnTrac Guide Wire Family
K173795 · DQX
Abbott Vascular
Cardiovascular · 29d