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
3025–3048 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 14, 2016
Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail...
K163200 · LOX
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Dec 14, 2016
Emerge PTCA Dilatation Catheter
K163174 · LOX
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Dec 13, 2016
MediGuide Technology System
K162643 · DQK
St Jude Medical
Cardiovascular · 82d
Cleared Dec 13, 2016
Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
K160941 · LIT
Brosmed Medical Co., Ltd.
Cardiovascular · 253d
Cleared Dec 13, 2016
Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor...
K160335 · DRF
St Jude Medical
Cardiovascular · 309d
Cleared Dec 13, 2016
AutoMark Module
K160218 · DQK
St Jude Medical
Cardiovascular · 319d
Cleared Dec 13, 2016
EnSite Precision Cardiac Mapping System v2.0
K160210 · DQK
St Jude Medical
Cardiovascular · 320d
Cleared Dec 08, 2016
Reprocessed Response Diagnostic Electrophysiology Catheters
K161827 · NLH
Innovative Health, LLC
Cardiovascular · 156d
Cleared Dec 08, 2016
Worker Guidewire
K160785 · DQX
Argon Medical Devices, Inc.
Cardiovascular · 261d
Cleared Dec 06, 2016
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
K162896 · DTZ
Medtronic, Inc.
Cardiovascular · 50d
Cleared Dec 06, 2016
Reprocessed Supreme Diagnostic Electrophysiology Catheters
K161769 · DRF
Innovative Health, LLC
Cardiovascular · 161d
Cleared Dec 06, 2016
Endura guidewire
K161702 · DQX
Vascular Solutions, Inc.
Cardiovascular · 169d
Cleared Dec 02, 2016
Pioneer Plus Catheter
K162418 · PDU
Philips Volcano
Cardiovascular · 94d
Cleared Dec 02, 2016
Altrix Precision Temperature Management System
K152266 · DWJ
Stryker Medical
Cardiovascular · 479d
Cleared Nov 30, 2016
Protek Solo 24 Fr Venous Cannula Set
K162214 · DWF
Cardiacassist, Inc.
Cardiovascular · 114d
Cleared Nov 30, 2016
SimplECG
K161431 · DXH
Nanowear, Inc.
Cardiovascular · 190d
Cleared Nov 28, 2016
VAMP Venous/Arterial Blood Management Protection System
K161962 · KRA
Edwards Lifesciences, LLC
Cardiovascular · 133d
Cleared Nov 28, 2016
Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
K160530 · DXQ
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 277d
Cleared Nov 22, 2016
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter,...
K162970 · QEW
Inari Medical
Cardiovascular · 29d
Cleared Nov 22, 2016
Pirouette 014
K162316 · LIT
Arravasc, Ltd.
Cardiovascular · 96d
Cleared Nov 22, 2016
Evolv Model BP7000 Upper Arm Blood Pressure Monitor
K162092 · DXN
Omron Healthcare, Inc.
Cardiovascular · 117d
Cleared Nov 22, 2016
Pacel Flow Directed Pacing Catheter
K161873 · LDF
St Jude Medical
Cardiovascular · 138d
Cleared Nov 22, 2016
Arm automatic blood pressure monitor
K161708 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 154d
Cleared Nov 22, 2016
Compass Cast and MAP
K161408 · DRS
Centurion Medical Products Corporation
Cardiovascular · 186d