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
1921–1944 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 28, 2020
Jade
K201794 · LIT
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 28d
Cleared Jul 28, 2020
TRUSELECT Microcatheter
K201792 · KRA
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Jul 24, 2020
Tempus LS - Manual
K200849 · LDD
Remote Diagnostic Technologies, Ltd....
Cardiovascular · 115d
Cleared Jul 23, 2020
AVVIGO Guidance System
K201713 · DQK
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jul 23, 2020
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K200738 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 122d
Cleared Jul 22, 2020
Reprocessed BRK Transseptal Needle
K192998 · NMK
Innovative Health, LLC
Cardiovascular · 268d
Cleared Jul 16, 2020
Arm Blood Pressure Monitor
K193456 · DXN
Ningbo Ranor Medical Science &...
Cardiovascular · 216d
Cleared Jul 15, 2020
LifeSignals ECG Remote Monitoring Patch Platform
K200690 · DRG
Lifesignals, Inc.
Cardiovascular · 121d
Cleared Jul 12, 2020
AGE Automatic Wrist Blood Pressure Monitor
K193628 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 199d
Cleared Jul 12, 2020
Automatic Upper Arm Blood Pressure Monitor
K193627 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 199d
Cleared Jul 10, 2020
HD Steth
K201299 · DQD
Hd Medical, Inc.
Cardiovascular · 56d
Cleared Jul 10, 2020
SmartLinx Vitals Plus Patient Monitoring System
K200856 · MWI
Capsule Technologie Sas
Cardiovascular · 100d
Cleared Jul 10, 2020
B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System
K200568 · JOW
B&J Manufacturing , Ltd.
Cardiovascular · 128d
Cleared Jul 10, 2020
Automatic Upper Arm Blood Pressure Monitor
K193624 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 197d
Cleared Jul 08, 2020
CAPERE Thrombectomy System
K201216 · QEW
Vascular Medcure, Inc.
Cardiovascular · 64d
Cleared Jul 08, 2020
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
K200955 · DXZ
Vascutek, Ltd.
Cardiovascular · 90d
Cleared Jul 08, 2020
B&J DVT Compression Devices MHH800/MHH800SQ
K200154 · JOW
B&J Manufacturing , Ltd.
Cardiovascular · 168d
Cleared Jul 03, 2020
LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command...
K200795 · MXD
Medtronic, Inc.
Cardiovascular · 99d
Cleared Jul 02, 2020
AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable...
K200674 · DSA
Atrility Medical, LLC
Cardiovascular · 108d
Cleared Jul 02, 2020
VenaOne
K200285 · JOW
Vena Group, LLC
Cardiovascular · 148d
Cleared Jul 02, 2020
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
K193259 · DXQ
Little Doctor Electronic...
Cardiovascular · 219d
Cleared Jul 01, 2020
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band,...
K201449 · KRH
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 30, 2020
LassoStar Circular Mapping Catheter
K193632 · DRF
Biosense Webster, Inc.
Cardiovascular · 186d
Cleared Jun 29, 2020
Twin-Pass Dual Access Catheter
K193119 · DQY
Vascular Solutions, LLC
Cardiovascular · 230d