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
2785–2808 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 21, 2017
Approach CTO Microwire Guide
K171897 · DQX
Cook Incorporated
Cardiovascular · 56d
Cleared Aug 21, 2017
MAMBA and MAMBA FLEX Microcatheters
K171452 · DQY
Boston Scientific Corporation
Cardiovascular · 96d
Cleared Aug 18, 2017
ACIST RXi Mini System
K172216 · DRQ
Acist Medical Systems, Inc.
Cardiovascular · 25d
Cleared Aug 18, 2017
QUANTIEN Measurement System
K172182 · DQK
St. Jude Medical (Now Part of the...
Cardiovascular · 30d
Cleared Aug 18, 2017
EMBA Hourglass Peripheral Embolization Device
K171845 · KRD
Emba Medical Limited
Cardiovascular · 59d
Cleared Aug 18, 2017
Optum TeleHealth Application
K171406 · DRG
United Health Group, Inc.
Cardiovascular · 98d
Cleared Aug 18, 2017
CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill...
K170431 · DXT
Coeur, Inc.
Cardiovascular · 186d
Cleared Aug 17, 2017
Advanced Perfusion System 1
K172220 · DTQ
Terumo Cardiovascular Systems...
Cardiovascular · 24d
Cleared Aug 17, 2017
Sequential Circulator SC-2004FC-OC
K171793 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 62d
Cleared Aug 17, 2017
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
K163339 · DPT
Spectralmd, Inc.
Cardiovascular · 262d
Cleared Aug 16, 2017
ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and...
K162768 · DSA
Integral Process Sas
Cardiovascular · 320d
Cleared Aug 10, 2017
MegaVac Mechanical Thrombectomy System
K171493 · QEX
Capture Vascular, Inc.
Cardiovascular · 80d
Cleared Aug 10, 2017
HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty...
K171431 · PST
Biostable Science & Engineering, Inc.
Cardiovascular · 87d
Cleared Aug 10, 2017
Peak Left Ventricular Vent Cannula, 20 Fr.
K170488 · DWF
Surge Cardiovascular
Cardiovascular · 174d
Cleared Aug 07, 2017
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook...
K171712 · DTK
William Cook Europe Aps
Cardiovascular · 59d
Cleared Aug 04, 2017
Maestro Microcatheter
K172081 · KRA
Merit Medical Systems, Inc.
Cardiovascular · 25d
Cleared Aug 03, 2017
eCareManager 4.1
K171322 · MSX
Visicu, Inc.
Cardiovascular · 90d
Cleared Aug 03, 2017
CADence System
K170928 · DQD
Aum Cardiovascular, Inc.
Cardiovascular · 127d
Cleared Aug 02, 2017
Accutorr 7/VS-900 Vital Signs Monitor
K170712 · MWI
Shenzhen Mindray Bio-Meidcal...
Cardiovascular · 146d
Cleared Aug 01, 2017
BP5S Wireless Blood Pressure Monitor
K171062 · DXN
Andon Health Co, Ltd.
Cardiovascular · 113d
Cleared Aug 01, 2017
LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
K170565 · QYX
Lifewatch Services, Inc.
Cardiovascular · 155d
Cleared Jul 31, 2017
Performer Introducer
K171999 · DYB
Cook Incorporated
Cardiovascular · 28d
Cleared Jul 31, 2017
Electronic Blood Pressure Monitor
K161845 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 391d
Cleared Jul 28, 2017
AXS Offset Delivery Assist Catheter
K163259 · DQY
Stryker Neurovascular
Cardiovascular · 249d