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
3457–3480 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 21, 2015
TM eCloud ECG Analysis System
K142349 · DQK
Telemed Solutions, Inc.
Cardiovascular · 395d
Cleared Sep 18, 2015
Export Advance Aspiration Catheter
K152335 · DXE
Medtronic, Inc.
Cardiovascular · 30d
Cleared Sep 18, 2015
Thoratec CentriMag Drainage (Venous) Cannula Kit
K152190 · DWF
Thoratec Corporation
Cardiovascular · 44d
Cleared Sep 18, 2015
Thoratec CentriMag Return (Arterial) Cannula Kit
K152161 · DWF
Thoratec Corporation
Cardiovascular · 46d
Cleared Sep 18, 2015
Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System
K151189 · JOW
Devon Medical Products
Cardiovascular · 137d
Cleared Sep 17, 2015
BodyGuardian Remote Monitoring System
K151188 · DSI
Preventice
Cardiovascular · 136d
Cleared Sep 17, 2015
SmartLinx Vitals Plus Patient Monitoring System
K151071 · MWI
Capsule Technologie Sas
Cardiovascular · 149d
Cleared Sep 17, 2015
LifePearl Microshperes
K150958 · KRD
MicroVention, Inc.
Cardiovascular · 161d
Cleared Sep 15, 2015
Occlusion Perfusion Catheter
K151554 · QEY
Advanced Catheter Therapies, Inc.
Cardiovascular · 98d
Cleared Sep 15, 2015
Rhythm View Workstation (non-streaming, steaming option)
K151245 · DQK
Topera, Inc.
Cardiovascular · 127d
Cleared Sep 11, 2015
CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
K143359 · DSI
Lifewatch Technologies , Ltd.
Cardiovascular · 291d
Cleared Sep 08, 2015
Fully Automatic Electronic Blood Pressure Monitor
K151460 · DXN
Andon Health Co, Ltd.
Cardiovascular · 99d
Cleared Sep 04, 2015
Art-line Single channel blood pressure system, Art-line Double channel blood...
K151040 · DRS
Biometrix , Ltd.
Cardiovascular · 137d
Cleared Sep 04, 2015
Volcano Visions PV .018 Digital IVUS Catheter
K150442 · OBJ
Volcano Corporation
Cardiovascular · 196d
Cleared Sep 03, 2015
Ebony PTA .014 RX Pheripheral Dilatation Catheter
K152230 · LIT
Natec Medical
Cardiovascular · 27d
Cleared Sep 02, 2015
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K151869 · DXN
Microlife Intellectual Property GmbH,...
Cardiovascular · 55d
Cleared Sep 02, 2015
Infinity CentralStation Wide
K151860 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 56d
Cleared Sep 02, 2015
V Series Monitoring System (including V12 and V21 Monitors)
K150352 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 203d
Cleared Sep 02, 2015
Panorama Patient Monitoring Network
K150082 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 230d
Cleared Aug 31, 2015
EarlySense Central Display Station (CDS)
K151006 · MSX
Earlysense, Ltd.
Cardiovascular · 138d
Cleared Aug 28, 2015
Eko Electronic Stethoscope System
K151319 · DQD
Eko Devices, Inc.
Cardiovascular · 102d
Cleared Aug 28, 2015
VIA 21 Microcatheter
K150894 · DQY
Sequent Medical, Inc.
Cardiovascular · 148d
Cleared Aug 27, 2015
5.5 F Worley Advanced LVI Lateral Vein Introducer
K152116 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 28d
Cleared Aug 27, 2015
Advanced Perfusion System 1
K151349 · DTQ
Terumo Cardiovascular Systems...
Cardiovascular · 99d