Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,182 results
2569–2592 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 21, 2018
BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
K173028 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 266d
Cleared Jun 19, 2018
Reprocessed DecaNav Diagnostic Electrophysiology Catheter
K180710 · NLH
Innovative Health, LLC
Cardiovascular · 92d
Cleared Jun 19, 2018
ViSi Mobile Monitoring System
K180472 · MHX
Sotera Wireless, Inc.
Cardiovascular · 117d
Cleared Jun 18, 2018
Savion DLVR Guidewire, Savion FLX Guidewire
K180726 · DQX
Boston Scientific, Inc.
Cardiovascular · 90d
Cleared Jun 18, 2018
AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816,...
K172895 · DXN
Ageless Health Industrial Co., Ltd.
Cardiovascular · 269d
Cleared CT Jun 17, 2018
FlowTriever Retrieval/Aspiration System
K181325 · QEW
Inari Medical, Inc.
Cardiovascular · 30d
Cleared Jun 14, 2018
Double Flexible Tipped Wire Guides
K181351 · DQX
Cook Incorporated
Cardiovascular · 23d
Cleared Jun 14, 2018
CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP...
K173977 · DQK
Biosense Webster, Inc.
Cardiovascular · 167d
Cleared Jun 14, 2018
LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch &...
K172011 · DRG
Hmicro, Inc.
Cardiovascular · 346d
Cleared Jun 11, 2018
Phenom 27 Catheter
K180959 · DQY
Cathera, Inc.
Cardiovascular · 60d
Cleared Jun 11, 2018
CAPERE Thrombectomy System
K180722 · QEW
Kp Medcure, Inc.
Cardiovascular · 84d
Cleared Jun 08, 2018
Sniper Infusion Catheter with Balloon Occlusion
K180904 · MJN
Embolx, Inc.
Cardiovascular · 63d
Cleared Jun 08, 2018
Integrated CardioRespiratory System
K173156 · MWJ
Sensydia, Inc.
Cardiovascular · 252d
Cleared Jun 06, 2018
Sentry IVC Filter
K181202 · DTK
Novate Medical , Ltd.
Cardiovascular · 30d
Cleared Jun 06, 2018
VTRUST Vital Signs Monitor, Model: TD-2300
K172221 · MWI
Taidoc Technology Corporation
Cardiovascular · 317d
Cleared Jun 04, 2018
Check-Flo Performer Introducer Micropuncture Radial Artery Access Set
K171609 · DYB
Cook Incorporated
Cardiovascular · 368d
Cleared Jun 01, 2018
CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT
K180238 · DQK
Biosense Webster, Inc.
Cardiovascular · 123d
Cleared Jun 01, 2018
Kenz Cardico1211
K172068 · DPS
Suzuken Co., Ltd.
Cardiovascular · 329d
Cleared May 31, 2018
CARDIOSAVE Intra-Aortic Balloon Pump
K181122 · DSP
Datascope Corp.
Cardiovascular · 31d
Cleared May 30, 2018
Pure Flow External Counter-Pulsation Device
K173483 · DRN
Xtreem Pulse, LLC
Cardiovascular · 198d
Cleared May 30, 2018
ANEROID SPHYGMOMANOMETER
K173246 · DXQ
Wenzhou Bokang Instruments Co., Ltd.
Cardiovascular · 236d
Cleared May 30, 2018
ScioCardio ECG Transmitter
K171019 · DRG
Synergen Technology Labs, LLC
Cardiovascular · 420d
Cleared May 29, 2018
Tri-Ad 2.0 Adams Tricuspid Band
K181132 · KRH
Medtronic
Cardiovascular · 29d
Cleared May 25, 2018
ProtekDuo Mini Veno-Venous Cannula Set
K181150 · DWF
Cardiacassist, Inc.
Cardiovascular · 24d