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
2377–2400 of 18,110
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