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
2449–2472 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 09, 2018
Teleport Microcatheter
K182360 · DQY
Orbusneich Medical Trading, Inc.
Cardiovascular · 71d
Cleared Nov 08, 2018
Wrist Blood Pressure Monitor Model BP4350
K182166 · DXN
Omron Healthcare, Inc.
Cardiovascular · 90d
Cleared Nov 08, 2018
Faros Mobile
K182030 · MLO
Bittium Biosignals , Ltd.
Cardiovascular · 101d
Cleared Nov 08, 2018
CardioInsight Cardiac Mapping System
K181918 · DQK
Medtronic, Inc.
Cardiovascular · 113d
Cleared Nov 08, 2018
VAMP Plus Venous/Arterial Blood Management Protection System
K181684 · KRA
Edwards Lifesciences, LLC
Cardiovascular · 135d
Cleared Nov 06, 2018
MiniGuard Arterial Safety Valve
K182442 · MJJ
Quest Medical, Inc.
Cardiovascular · 60d
Cleared Nov 06, 2018
Günther Tulip® Vena Cava Filter Retrieval Set
K181757 · MMX
Cook Incorporated
Cardiovascular · 127d
Cleared Nov 06, 2018
Finapres Nova Noninvasive Hemodynamic Monitor
K173916 · DXN
Finapres Medical Systems B.V.
Cardiovascular · 319d
Cleared Nov 02, 2018
Wrist Blood Pressure Monitor Model BP6100
K182127 · DXN
Omron Healthcare, Inc.
Cardiovascular · 88d
Cleared Nov 02, 2018
CDI Blood Parameter Monitoring System 550
K182110 · DRY
Terumo Cardiovascular Systems...
Cardiovascular · 88d
Cleared Nov 01, 2018
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
K182276 · DXT
Bayer Medical Care, Inc.
Cardiovascular · 71d
Cleared Nov 01, 2018
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD...
K182273 · DXT
Bayer Medical Care, Inc.
Cardiovascular · 71d
Cleared Oct 29, 2018
MC3 Vascular Access Kit 21030
K182914 · DRE
Mc3 Incorporated
Cardiovascular · 11d
Cleared Oct 27, 2018
Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
K181458 · NLH
Innovative Health, LLC
Cardiovascular · 145d
Cleared Oct 26, 2018
TSI Transseptal Introducer
K181031 · DYB
Pressure Products Medical Device...
Cardiovascular · 191d
Cleared Oct 26, 2018
Polyethylene Catheter
K180286 · DQO
Cook Incorporated
Cardiovascular · 267d
Cleared Oct 25, 2018
DyeVert PLUS EZ Contrast Reduction System
K181936 · DXT
Osprey Medical, Inc.
Cardiovascular · 98d
Cleared Oct 24, 2018
KODEX EPD System
K180940 · DQK
Philips Medical Systems Nederland B.V.
Cardiovascular · 197d
Cleared Oct 24, 2018
VAMP Optima closed blood sampling system
K180275 · KRA
Edwards Lifesciences, LLC
Cardiovascular · 266d
Cleared Oct 22, 2018
Comarch e-Care Platform
K181248 · DRG
Comarch Healthcare SA
Cardiovascular · 165d
Cleared Oct 19, 2018
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping...
K182644 · DQK
Abbott
Cardiovascular · 25d
Cleared Oct 19, 2018
DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure...
K182586 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Oct 18, 2018
Quantum Ventilation Module
K181942 · DTX
Spectrum Medical , Ltd.
Cardiovascular · 90d
Cleared Oct 18, 2018
Reprocessed Torqr Diagnostic EP Catheter
K181618 · NLH
Innovative Health, LLC
Cardiovascular · 121d