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
2641–2664 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 12, 2018
Microcatheter
K173560 · DQY
Surmodics,Inc.
Cardiovascular · 56d
Cleared Jan 11, 2018
Automated ankle brachial pressure index measuring device
K172655 · JOM
Mesi D.O.O.; Mesi, Development of...
Cardiovascular · 128d
Cleared Jan 11, 2018
Microcatheter and guide-wire system
K171665 · KRA
Suzhou Hengrui Disheng Medical Co., Ltd.
Cardiovascular · 220d
Cleared Jan 11, 2018
Digital Electrocardiograph
K171517 · DPS
Biocare Bio-Medical Equipment Co., Ltd.
Cardiovascular · 232d
Cleared Jan 10, 2018
Tempus Pro Patient Monitor
K173768 · MHX
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 30d
Cleared Jan 10, 2018
ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE
K173563 · DXC
Tz Medical, Inc.
Cardiovascular · 54d
Cleared Jan 10, 2018
Epicardia Anywhere
K173170 · DSI
Medicomp, Inc.
Cardiovascular · 103d
Cleared Jan 10, 2018
Digital Blood Pressure Monitor-Wrist Style
K171833 · DXN
Shenzhen Combei Technology Co., Ltd.
Cardiovascular · 205d
Cleared Jan 10, 2018
Amplatz Support Wire Guide with Apex Curve
K171445 · DQX
Cook Incorporated
Cardiovascular · 239d
Cleared Jan 05, 2018
EnsoETM
K172029 · PLA
Attune Medical
Cardiovascular · 184d
Cleared Jan 05, 2018
Roadrunner Extra Support Wire Guide
K171948 · DQX
Cook Incorporated
Cardiovascular · 190d
Cleared Jan 04, 2018
Attain Assist CS Access Catheter
K171819 · DQY
Creganna Medical Also Doing Business...
Cardiovascular · 199d
Cleared Jan 04, 2018
ePatch
K171410 · DSH
Braemar Manufacturing, LLC
Cardiovascular · 234d
Cleared Jan 04, 2018
WAVE Clinical Platform
K171056 · MWI
Excel Medical Electronics, LLC
Cardiovascular · 269d
Cleared Dec 22, 2017
SOZO
K172507 · DSB
ImpediMed Limited
Cardiovascular · 126d
Cleared Dec 21, 2017
Elite HV Radial
K173287 · DYB
Galt Medical Corp.
Cardiovascular · 66d
Cleared Dec 21, 2017
SafeSept Needle Free Transseptal Guidewire
K172893 · DRC
Pressure Products Medical Device...
Cardiovascular · 90d
Cleared Dec 20, 2017
Peel-Away Introducer Set
K173685 · DYB
Cook Incorporated
Cardiovascular · 19d
Cleared Dec 20, 2017
speX Support Catheter
K173662 · DQY
Reflow Medical, Inc.
Cardiovascular · 21d
Cleared Dec 20, 2017
Sentrant Introducer Sheath with Hydrophilic Coating
K171866 · DYB
Medtronic Vascular, Inc.
Cardiovascular · 181d
Cleared Dec 20, 2017
Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus...
K171275 · DYB
Cook Incorporated
Cardiovascular · 233d
Cleared Dec 19, 2017
TBL-ABI System
K173696 · JOM
Ld Technology, LLC
Cardiovascular · 18d
Cleared Dec 19, 2017
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
K173618 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 27d
Cleared Dec 19, 2017
Reusable Blood Pressure Cuff
K171889 · DXQ
Suzhou Minhua Medical Apparatus...
Cardiovascular · 176d