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
2329–2352 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 29, 2019
Loop System
K181352 · DQA
Spry Health, Inc.
Cardiovascular · 311d
Cleared Mar 29, 2019
3880 MRI Patient Monitoring System
K180903 · MWI
Iradimed Corporation
Cardiovascular · 357d
Cleared Mar 27, 2019
Wearable Device, Home Package in Carry Case with Homehub, Home Package in...
K190073 · MSX
Current Health , Ltd.
Cardiovascular · 70d
Cleared Mar 27, 2019
WOLF Thrombectomy Device
K182835 · QEW
880 Medical, LLC
Cardiovascular · 169d
Cleared Mar 27, 2019
Accutorr 7/VS-900/VS-900c Vital Signs Monitor
K182821 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 174d
Cleared Mar 27, 2019
eKuore One electronic interface for stethoscope
K181882 · DQD
Chip Ideas Electronics S.L.
Cardiovascular · 257d
Cleared Mar 26, 2019
transGlideXT Expandable Introducer
K181817 · DYB
Transaortic Medical, Inc.
Cardiovascular · 260d
Cleared Mar 26, 2019
MobileECG 2 BT
K181658 · DSI
Memtec Corporation
Cardiovascular · 274d
Cleared Mar 24, 2019
Arm Blood Pressure Monitor
K183491 · DXN
Xuzhou Yongkang Electronic Science...
Cardiovascular · 97d
Cleared Mar 22, 2019
Telescope Guide Extension Catheter
K183353 · DQY
Medtronic, Inc.
Cardiovascular · 109d
Cleared Mar 22, 2019
Polyethylene Catheter
K181722 · DQO
Cook Incorporated
Cardiovascular · 266d
Cleared Mar 21, 2019
ExpanSure Transseptal Dilation System
K182064 · DRE
Baylis Medical Company, Inc.
Cardiovascular · 232d
Cleared Mar 21, 2019
A&D Medical Blood Pressure Monitors
K173191 · DXN
A&D Company, Ltd.
Cardiovascular · 535d
Cleared Mar 19, 2019
Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System
K190423 · JOW
Devon Medical Products (Jiangsu), Ltd.
Cardiovascular · 25d
Cleared Mar 18, 2019
Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity...
K183511 · DTZ
Medtronic, Inc.
Cardiovascular · 90d
Cleared Mar 15, 2019
MAMBA and MAMBA Flex Microcatheters
K190401 · DQY
Boston Scientific Corporation
Cardiovascular · 24d
Cleared Mar 15, 2019
SelectSite C304-HIS Deflectable Catheter System
K183493 · DQY
Medtronic, Inc.
Cardiovascular · 88d
Cleared Mar 15, 2019
CardioFlux with Faraday Analytical Cloud
K182571 · DPS
Genetesis, Inc.
Cardiovascular · 178d
Cleared Mar 14, 2019
VASOBand Vascular Compression Device
K190318 · DXC
Vasoinnovations, Inc.
Cardiovascular · 29d
Cleared Mar 14, 2019
Omron Model BP7900 Blood Pressure Monitor + EKG
K182579 · DXN
Omron Healthcare, Inc.
Cardiovascular · 176d
Cleared Mar 13, 2019
BeneVision Central Monitoring System
K183238 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 113d
Cleared Mar 13, 2019
Venture 0.014 Catheter
K182570 · DQY
Vascular Solutions, LLC
Cardiovascular · 176d
Cleared Mar 12, 2019
Microlife Digital Blood Pressure Monitor
K183469 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 88d
Cleared Mar 11, 2019
Inno-Pathwire
K182553 · DQX
Suzhou Innomed Medical Device Co., Ltd.
Cardiovascular · 175d