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
1705–1728 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 23, 2021
Dayspring
K210885 · JOW
Koya Medical, Inc.
Cardiovascular · 29d
Cleared Apr 23, 2021
SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
K210626 · LIT
Cordis Corporation
Cardiovascular · 52d
Cleared Apr 22, 2021
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+...
K203365 · PPN
Shockwave Medical, Inc.
Cardiovascular · 157d
Cleared Apr 22, 2021
DVT-PRO
K203353 · JOW
Daesung Maref Co., Ltd.
Cardiovascular · 160d
Cleared Apr 21, 2021
VASSALLO GT
K203533 · DQX
Filmecc Co., Ltd.
Cardiovascular · 140d
Cleared CT Apr 20, 2021
SoundBite Crossing System - Peripheral (14P)
K210839 · PDU
Soundbite Medical Solutions, Inc.
Cardiovascular · 29d
Cleared Apr 15, 2021
Instylla Microcatheter 1.2
K210808 · KRA
Instylla, Inc.
Cardiovascular · 29d
Cleared Apr 15, 2021
Verrata PLUS Pressure Guide Wire
K210235 · DQX
Volcano Corporation
Cardiovascular · 77d
Cleared CT Apr 14, 2021
Artimes pro Balloon Dilatation Catheter
K203390 · LOX
Brosmed Medical Co., Ltd.
Cardiovascular · 147d
Cleared Apr 08, 2021
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K202729 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 202d
Cleared Apr 06, 2021
Endovascular Dilator and Sets
K210734 · DRE
Cook Incorporated
Cardiovascular · 26d
Cleared Apr 06, 2021
AcQCross Qx Integrated Transseptal Dilator/Needle
K210685 · DYB
Acutus Medical, Inc.
Cardiovascular · 29d
Cleared Apr 06, 2021
SiteSeal SV
K210681 · DXC
Ensite Vascular
Cardiovascular · 29d
Cleared Apr 06, 2021
Vascutek Gelsoft Plus ERS Vascular Graft
K202703 · DSY
Vascutek, Ltd.
Cardiovascular · 202d
Cleared Apr 05, 2021
Stockert S5 System
K210130 · DTQ
Livanova Deutschland, GmbH
Cardiovascular · 76d
Cleared Apr 02, 2021
SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System
K203310 · JOW
Jiangsu Synecoun Medical Technology...
Cardiovascular · 143d
Cleared Apr 01, 2021
Omron Model BP7900 Blood Pressure Monitor + EKG
K202228 · DXN
Omron Healthcare, Inc.
Cardiovascular · 237d
Cleared Apr 01, 2021
AMG PMP Pediatric
K202206 · DTZ
Eurosets S.R.L
Cardiovascular · 239d
Cleared Apr 01, 2021
B-Capta
K202154 · DRY
Livanova Deutschland, GmbH
Cardiovascular · 241d
Not Cleared Apr 01, 2021
Gili Pro BioSensor (also known as “Gili BioSensor System”)
DEN200038 · QOK
Continuse Biometrics , Ltd.
Cardiovascular · 293d
Cleared Mar 31, 2021
Guidion
K210110 · DQY
Imds Operations B.V.
Cardiovascular · 71d
Cleared Mar 30, 2021
3M Bair Hugger Temperature Management System (Model 675)
K210603 · DWJ
3M Company
Cardiovascular · 29d
Cleared Mar 28, 2021
DVT-4000S
K203417 · JOW
Daesung Maref Co., Ltd.
Cardiovascular · 129d
Cleared Mar 26, 2021
TandemHeart Pump and Escort Controller
K202751 · QNR
Cardiacassist, Inc.
Cardiovascular · 186d