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
1825–1848 of 18,110
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