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
2257–2280 of 18,110
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