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
745–768 of 18,110
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