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
1201–1224 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 15, 2023
Arm Blood Pressure Monitor
K222869 · DXN
Andon Health Co, Ltd.
Cardiovascular · 146d
Cleared Feb 15, 2023
ZEUS System
K222389 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 191d
Cleared Feb 13, 2023
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
K223186 · QEW
Penumbra, Inc.
Cardiovascular · 124d
Cleared Feb 06, 2023
Care Team Portal
K222398 · DRG
Vivify Health, Inc.
Cardiovascular · 182d
Cleared Feb 06, 2023
ClotTriever Thrombectomy System
K221531 · QEW
Inari Medical, Inc.
Cardiovascular · 256d
Cleared Feb 03, 2023
14F iSLEEVE™ Introducer Set
K230051 · DYB
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Feb 03, 2023
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K223026 · OWQ
Northeast Scientific, Inc.
Cardiovascular · 127d
Cleared Feb 03, 2023
Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular...
K222153 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 198d
Cleared Feb 03, 2023
Anivia SG1000 Pump Console
K221491 · DWA
Apmtd, Inc.
Cardiovascular · 256d
Cleared Feb 03, 2023
IntelliVue Patient Monitor MX750 (866471)
K221348 · MHX
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 270d
Cleared Jan 21, 2023
VX1+
K223516 · DQK
Volta Medical
Cardiovascular · 60d
Cleared Jan 20, 2023
Highlander™ 014 PTA Balloon Dilatation Catheter
K223177 · LIT
C.R. Bard, Inc.
Cardiovascular · 101d
Cleared Jan 20, 2023
Capiflo 5001
K222158 · JOW
K&L Distributing, Inc.
Cardiovascular · 184d
Cleared Jan 19, 2023
Low Profile Companion Sheath
K223872 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 27d
Cleared Jan 19, 2023
Medaica M1 Telehealth Stethoscope
K223166 · DQD
Medaica, Inc.
Cardiovascular · 104d
Cleared Jan 19, 2023
Tunnel Crossing Catheter
K221163 · PDU
Tractus Vascular, LLC
Cardiovascular · 272d
Cleared Jan 12, 2023
Garmin ECG App
K221774 · QDA
Garmin International, Inc.
Cardiovascular · 205d
Cleared Jan 11, 2023
Artix BG
K223000 · QEW
Inari Medical
Cardiovascular · 105d
Cleared CT Jan 06, 2023
CSF-3
K221260 · DPS
Cardiacsense
Cardiovascular · 249d
Cleared Jan 06, 2023
T3 Platform software
K213423 · PLB
Etiometry, Inc.
Cardiovascular · 443d
Cleared Jan 04, 2023
Radial Artery Compression Tourniquets
K222182 · DXC
Beijing Demax Medical Technology Co.,Ltd
Cardiovascular · 166d
Cleared CT Dec 30, 2022
Biobeat Platform-2 and BB-613WP Patch
K222010 · DQA
Biobeat Technologies , Ltd.
Cardiovascular · 176d
Cleared Dec 30, 2022
Isolator® Linear Pen (MLP1)
K221358 · OCL
AtriCure, Inc.
Cardiovascular · 233d
Cleared Dec 30, 2022
EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
K210313 · DRF
Shanghai Microport EP Medtech Co., Ltd.
Cardiovascular · 695d