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
817–840 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 22, 2024
Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA)
K234041 · DXN
Andon Health Co, Ltd.
Cardiovascular · 123d
Cleared Apr 19, 2024
Bio-Medicus Life Support Catheter and Introducer
K240534 · QHW
Medtronic, Inc.
Cardiovascular · 53d
Cleared Apr 19, 2024
LIFEPAK® 35 AC Power Adapter (41335-000001)
K240162 · MPD
Stryker Physio-Control
Cardiovascular · 88d
Cleared Apr 19, 2024
ICE Aspiration System
K234073 · QEW
Expanse Medical, Inc.
Cardiovascular · 119d
Cleared Apr 19, 2024
Patient Monitor (iX10, iX12, iX15)
K232962 · MHX
Edan Instruments, Inc.
Cardiovascular · 211d
Cleared Apr 18, 2024
HotDog Warming Mattress + Return Electrode
K232627 · DWJ
Augustine Temperature Management, LLC
Cardiovascular · 233d
Cleared Apr 15, 2024
Novalung ultimate kit (US)
K232926 · QJZ
Fresenius Medical Care Renal...
Cardiovascular · 208d
Cleared Apr 10, 2024
Keikku Electronic stethoscope
K233313 · DQD
Lapsi Health Holding B.V.
Cardiovascular · 194d
Cleared Apr 09, 2024
TransForm McCarthy Mitral Annuloplasty Ring (TF)
K232599 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 225d
Cleared Apr 05, 2024
CorVista System with PH Add-On
K233666 · SAT
Analytics For Life, Inc.
Cardiovascular · 142d
Cleared Apr 05, 2024
APPRAISE-HRI
K233249 · SAR
The Surgeon General, Department of...
Cardiovascular · 190d
Cleared Apr 05, 2024
MCG-S (AM1000)
K232823 · DPS
Amcg Co., Ltd.
Cardiovascular · 205d
Cleared Apr 04, 2024
Reprocessed VersaCross Steerable Sheath
K232037 · PNE
Innovative Health, LLC
Cardiovascular · 269d
Cleared Apr 02, 2024
Zoom 6F Insert Catheters
K233975 · DQO
Imperative Care, Inc.
Cardiovascular · 109d
Cleared Apr 01, 2024
AlphaVac MMA F1885 System (H787253020)
K240397 · QEZ
AngioDynamics, Inc.
Cardiovascular · 52d
Cleared Apr 01, 2024
Talis EMR with Talis +ACG (Talis EMR with +ACG)
K233133 · MWI
Talis Clinical, LLC
Cardiovascular · 187d
Cleared Mar 28, 2024
LINQ II™ Insertable Cardiac Monitor (ICM)
K240693 · MXD
Medtronic, Inc.
Cardiovascular · 15d
Cleared Mar 28, 2024
Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration...
K233909 · QEW
Argon Medical Devices, Inc.
Cardiovascular · 107d
Cleared Mar 28, 2024
CORE 500 Digital Stethoscope
K233609 · DQD
Eko Health, Inc.
Cardiovascular · 136d
Cleared Mar 28, 2024
Eko Low Ejection Fraction Tool (ELEFT)
K233409 · QYE
Eko Health, Inc.
Cardiovascular · 174d
Cleared Mar 28, 2024
Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040,...
K232013 · PNO
Goodman Co., Ltd.
Cardiovascular · 266d
Cleared Mar 28, 2024
Advanta VXT Vascular Graft, Flixene Vascular Graft
K231972 · DSY
Atrium Medical Corporation
Cardiovascular · 269d
Cleared Mar 26, 2024
Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)
K231984 · DXN
Shenzhen Hingmed Medical Instrument...
Cardiovascular · 265d
Cleared Mar 25, 2024
Micropuncture Introducer Sets
K240589 · DYB
Cook, Medical
Cardiovascular · 24d