Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,182 results
1897–1920 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 28, 2020
External Counterpulsation System, Soulaire
K202108 · DRN
Vamed Medical Instrument Co., Ltd.
Cardiovascular · 29d
Cleared Aug 28, 2020
Infinity M300
K200859 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 149d
Cleared Aug 27, 2020
Essence 55SP Large Monitor System
K201162 · DXJ
Shenyang Torch-Bigtide Digital...
Cardiovascular · 119d
Cleared Aug 26, 2020
Hydrophilic Coating Guide Wire
K193653 · DQX
Suzhou Hengrui Disheng Medical Co., Ltd.
Cardiovascular · 240d
Cleared Aug 26, 2020
CER-S
K193177 · MLO
Cardiocalm
Cardiovascular · 282d
Cleared Aug 20, 2020
Electronic Blood Pressure Monitor
K200939 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 134d
Cleared Aug 19, 2020
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
K193595 · QEW
Penumbra, Inc.
Cardiovascular · 240d
Cleared Aug 19, 2020
VariLymph 12 pro
K193476 · JOW
Slk Medical GmbH
Cardiovascular · 247d
Cleared Aug 17, 2020
EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
K200648 · QEY
Ekos Corporation
Cardiovascular · 158d
Cleared Aug 13, 2020
Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator,...
K201916 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 34d
Cleared Aug 07, 2020
Fountain ValveTip Infusion Catheter
K193082 · KRA
Merit Medical Systems, Inc.
Cardiovascular · 276d
Cleared Aug 06, 2020
ClariVein IC
K201907 · KRA
Merit Medical Systems, Inc.
Cardiovascular · 28d
Cleared Aug 06, 2020
Pentaray Nav eco High-Density Mapping Catheter
K201750 · MTD
Biosense Webster, Inc.
Cardiovascular · 41d
Cleared Aug 06, 2020
ManaFlow
K200353 · JOW
Manamed, Inc.
Cardiovascular · 175d
Cleared Aug 06, 2020
NHancer Rx
K200324 · DQY
Imds Operations B.V.
Cardiovascular · 178d
Cleared Aug 05, 2020
Enhanced External Counter Pulsation Device Plus Omay-A
K191955 · DRN
Omay(Guangzhou)Med Technologies Co.,...
Cardiovascular · 380d
Cleared Aug 04, 2020
ECG Monitor App
K201168 · QDA
Samsung Electronics Co., Ltd.
Cardiovascular · 95d
Cleared Aug 03, 2020
Arm-Type Fully Automatic Digital Blood Pressure Monitor
K200649 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 144d
Cleared Aug 03, 2020
Attain Select II + SureValve delivery catheter system, Attain Command +...
K192712 · DQY
Medtronic, Inc.
Cardiovascular · 311d
Cleared Jul 31, 2020
Carto Octaray Mapping Catheter with Trueref Technology
K193237 · MTD
Biosense Webster, Inc.
Cardiovascular · 249d
Cleared Jul 30, 2020
HI-TORQUE PROCEED Guide Wire Family
K201834 · DQX
Abbott Vascular
Cardiovascular · 28d
Cleared Jul 30, 2020
Reprocessed NRG Transseptal Needle
K200060 · QLZ
Innovative Health, LLC
Cardiovascular · 199d
Cleared Jul 29, 2020
Bioflux Software II
K201040 · DSH
Biotricity
Cardiovascular · 119d
Cleared Jul 29, 2020
Superpipe Angiographic Catheter
K193647 · DQO
Suzhou Hengrui Disheng Medical Co., Ltd.
Cardiovascular · 212d