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
2209–2232 of 18,110
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