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
1633–1656 of 18,182
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