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
1633–1656 of 18,110
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 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 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