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
1561–1584 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 29, 2021
Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor
K210770 · DXN
Andon Health Co, Ltd.
Cardiovascular · 136d
Cleared Jul 28, 2021
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook...
K211875 · DTK
William Cook Europe Aps
Cardiovascular · 41d
Cleared Jul 28, 2021
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip...
K211874 · DTK
William Cook Europe Aps
Cardiovascular · 41d
Cleared Jul 27, 2021
Aveir Introducer
K211989 · DYB
Abbott Medical
Cardiovascular · 29d
Cleared Jul 27, 2021
doctorgram Stethoscope DES-I
K210736 · DQD
Gv Concepts
Cardiovascular · 138d
Cleared Jul 27, 2021
DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
K210664 · PDU
Ra Medical Systems,Inc
Cardiovascular · 144d
Cleared Jul 26, 2021
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
K210477 · OCL
AtriCure, Inc.
Cardiovascular · 157d
Cleared Jul 23, 2021
CardioCurve Steerable Sheath
K210185 · DYB
Talon Surgical
Cardiovascular · 179d
Cleared Jul 23, 2021
VS Newborn Heart Rate Monitor
K201887 · DQA
Surepulse Medical Limited
Cardiovascular · 380d
Cleared Jul 22, 2021
Reveal LINQ Insertable Cardiac Monitor
K212008 · MXD
Medtronic, Inc.
Cardiovascular · 24d
Cleared Jul 22, 2021
FlowSaver Blood Filter
K210176 · CAC
Inari Medical
Cardiovascular · 181d
Cleared Jul 21, 2021
LifeSignals Multi-Parameter Remote Monitoring Platform
K202868 · DRG
Lifesignals, Inc.
Cardiovascular · 296d
Cleared Jul 20, 2021
Vital Signs
K211906 · QME
Oxehealth Limited
Cardiovascular · 29d
Cleared Jul 20, 2021
LifeLens Wireless ECG Monitor
K203168 · DSH
LifeLens Technologies, Inc.
Cardiovascular · 270d
Cleared Jul 19, 2021
Z-6 Atrioseptostomy Catheter
K211910 · DXF
NuMED, Inc.
Cardiovascular · 28d
Cleared Jul 16, 2021
SwiftNINJA Steerable Microcatheter
K211525 · KRA
Merit Medical Systems, Inc.
Cardiovascular · 60d
Cleared Jul 16, 2021
Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope...
K203435 · MHX
Nihon Kohden Corporation
Cardiovascular · 235d
Cleared Jul 15, 2021
ReCross
K210431 · DQY
Imds Operations B.V.
Cardiovascular · 153d
Cleared Jul 15, 2021
Bio-Medicus Life Support Catheter and Introducer
K201100 · DWF
Medtronic, Inc.
Cardiovascular · 447d
Cleared Jul 12, 2021
EOS PMP
K211495 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 60d
Cleared Jul 12, 2021
Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
K203556 · DSA
Medtronic, Inc.
Cardiovascular · 217d
Cleared Jul 09, 2021
AortaSTAT Occlusion Device
K210602 · MJN
Renalpro Medical, Inc.
Cardiovascular · 130d
Cleared Jul 09, 2021
Tamarin Blue PTCA RX Dilatation Catheter
K210012 · LOX
Natec Medical , Ltd.
Cardiovascular · 186d
Cleared Jul 08, 2021
HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced...
K211465 · DQK
Edwards Lfesciences
Cardiovascular · 58d