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
2689–2712 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 20, 2017
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
K173044 · DXQ
Ningbo Albert Novosino Co., Ltd.
Cardiovascular · 53d
Cleared Nov 20, 2017
Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator...
K172984 · DTZ
Medtronic, Inc.
Cardiovascular · 54d
Cleared Nov 20, 2017
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip...
K172584 · DTK
William Cook Europe Aps
Cardiovascular · 84d
Cleared Nov 20, 2017
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip...
K172557 · DTK
William Cook Europe Aps
Cardiovascular · 88d
Cleared Nov 17, 2017
MR Wire Guide Wire Straight, MR Wire Guide Wire Angled
K173423 · DQX
Nano4imaging GmbH
Cardiovascular · 16d
Cleared Nov 17, 2017
Performer Introducer
K173068 · DYB
Cook Incorporated
Cardiovascular · 49d
Cleared Nov 17, 2017
Duravess bovine pericardial vascular patch
K172660 · PSQ
Edwards Lifesciences, LLC
Cardiovascular · 73d
Cleared Nov 17, 2017
Masimo Root Monitoring System and Accessories
K171121 · MWI
Masimo Corporation
Cardiovascular · 214d
Cleared Nov 17, 2017
Langston dual lumen catheter
K170544 · DQO
Vascular Solutions, Inc.
Cardiovascular · 266d
Cleared Nov 16, 2017
OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU)
K173284 · OBJ
Boston Scientific Corporation
Cardiovascular · 31d
Cleared Nov 16, 2017
Kardia Band System
K171816 · DXH
AliveCor, Inc.
Cardiovascular · 150d
Cleared Nov 16, 2017
MC3 QuickFlow Dual Lumen Catheter
K171610 · PZS
Mc3 Incorporated
Cardiovascular · 168d
Cleared Nov 16, 2017
Intra.Ox Handheld Tissue Oximeter
K163472 · MUD
Vioptix, Inc.
Cardiovascular · 339d
Cleared Nov 15, 2017
Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and...
K173289 · DQO
Cook Incorporated
Cardiovascular · 30d
Cleared Nov 15, 2017
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15,...
K171901 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 142d
Cleared Nov 13, 2017
CXI TriForce Peripheral Crossing Set
K170931 · KRA
Cook Incorporated
Cardiovascular · 229d
Cleared Nov 09, 2017
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit,...
K172458 · DRS
Smiths Medical Asd, Inc.
Cardiovascular · 87d
Cleared Nov 09, 2017
WATCHDOG Hemostasis Valve Kit
K172453 · DQX
Boston Scientific Corporation
Cardiovascular · 87d
Cleared Nov 09, 2017
MX40 Release B.07
K172226 · MHX
Philips Medical Systems
Cardiovascular · 107d
Cleared Nov 09, 2017
ulrichINJECT CT motion
K171392 · IZQ
Ulrich GmbH & Co. KG
Cardiovascular · 182d
Cleared Nov 09, 2017
Odyssey Micro Catheter
K170664 · DQY
Heraeus Medical Components, LLC
Cardiovascular · 248d
Cleared Nov 08, 2017
ER-REBOA Catheter
K172790 · MJN
Prytime Medical Devices, Inc.
Cardiovascular · 54d
Cleared Nov 08, 2017
SurgicalPreview
K171534 · PZO
Endo Vantage, LLC
Cardiovascular · 167d
Cleared Nov 07, 2017
Rooti Rx ECG Event Recorder, Rooti Link APP Software
K163694 · DRG
Rooti Labs , Ltd.
Cardiovascular · 314d