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
2497–2520 of 18,110
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 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