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
2281–2304 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 16, 2019
Fully Automatic Electronic Blood Pressure Monitor
K183534 · DXN
Andon Health Co, Ltd.
Cardiovascular · 148d
Cleared May 16, 2019
Tel-O-Graph
K173895 · DXN
I.E.M. Industrielle Entwicklung and...
Cardiovascular · 511d
Cleared May 15, 2019
Liba3 System
K182532 · DSI
National Cardiac, Inc.
Cardiovascular · 243d
Cleared May 14, 2019
D'Vill Introducer
K190974 · DYB
NuMED, Inc.
Cardiovascular · 29d
Cleared May 10, 2019
Triangle System
K183319 · DXH
AliveCor, Inc.
Cardiovascular · 161d
Cleared May 09, 2019
Wingman 14C Crossing Catheter
K190393 · DQY
Reflow Medical, Inc.
Cardiovascular · 79d
Cleared May 08, 2019
Reprocessed ViewFlex Xtra ICE Catheter
K182238 · OWQ
Stryker Sustainability Solutions
Cardiovascular · 261d
Cleared May 06, 2019
BioCardia 8.5 F Avance Steerable lntroducer
K190941 · DYB
Biocardia, Inc.
Cardiovascular · 26d
Cleared May 02, 2019
Cocoon Convective Warming System
K181671 · DWJ
Care Essentials Pty, Ltd.
Cardiovascular · 311d
Cleared May 01, 2019
TruWave Disposable Pressure Transducer
K183413 · DXO
Edwards Lifeciences, LLC
Cardiovascular · 142d
Cleared Apr 30, 2019
Medtronic Model 5392 External Pulse Generator (EPG)
K190825 · DTE
Medtronic, Inc.
Cardiovascular · 29d
Cleared Apr 29, 2019
Aspiron(TM) Aspiration Catheter
K190619 · QEZ
Meril Life Sciences Private Limited
Cardiovascular · 49d
Cleared Apr 26, 2019
Philips IntelliVue XDS Software
K182637 · MSX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 214d
Cleared Apr 25, 2019
Multi-Sideport Catheter Infusion Set
K182071 · KRA
Cook Incorporated
Cardiovascular · 267d
Cleared Apr 24, 2019
Occlusion Balloon Catheter
K183679 · MJN
Qxmedical, LLC
Cardiovascular · 117d
Cleared Apr 24, 2019
A&D Medical Blood Pressure Monitors
K173065 · DXN
A&D Company, Ltd.
Cardiovascular · 572d
Cleared Apr 23, 2019
EverCrossTM 0.035 OTW PTA Dilatation Catheter
K190753 · LIT
Medtronic, Inc. (Formerly D.B.A. Ev3,...
Cardiovascular · 29d
Cleared Apr 23, 2019
Reprocessed Supreme Diagnostic Electrophysiology Catheter
K182386 · DRF
Innovative Health, LLC
Cardiovascular · 231d
Cleared Apr 22, 2019
exGraft, exGraft Carbon
K183613 · DSY
Peca Labs
Cardiovascular · 117d
Cleared Apr 18, 2019
Guide Sheath
K190644 · DYB
Surmodics,Inc.
Cardiovascular · 36d
Cleared Apr 18, 2019
NeoForm Annuloplasty Ring
K190506 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 48d
Cleared Apr 18, 2019
Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J,...
K182457 · DQX
Brivant Limited (Lake Region Medical)
Cardiovascular · 223d
Cleared Apr 17, 2019
HEM-6410T-ZL Wrist Blood Pressure Monitor
K190693 · DXN
Omron Healthcare, Inc.
Cardiovascular · 30d
Cleared Apr 17, 2019
VersaCross Steerable Sheath, VersaCross Transseptal Dilator
K190688 · DYB
Baylis Medical Company, Inc.
Cardiovascular · 30d