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
2233–2256 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 17, 2019
M-Y Sheath
K190369 · DYB
Ram Medical Innovations, Inc.
Cardiovascular · 61d
Cleared Apr 17, 2019
SmartLinx Vitals Plus Patient Monitoring System
K183638 · MWI
Capsule Technologie
Cardiovascular · 112d
Cleared Apr 17, 2019
Stasis Monitoring System
K183634 · MWI
Stasis Labs, Inc.
Cardiovascular · 112d
Cleared Apr 17, 2019
JETi 88 Peripheral Thrombectomy System
K183403 · QEZ
Walk Vascular, LLC
Cardiovascular · 131d
Cleared Apr 17, 2019
Dr. Amplatz Micro Plug
K182944 · KRD
Ka Medical, LLC
Cardiovascular · 176d
Cleared Apr 17, 2019
eMurmur ID
K181988 · DQD
Csd Labs GmbH
Cardiovascular · 266d
Cleared Apr 16, 2019
Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native...
K181541 · MWI
Andon Health Co, Ltd.
Cardiovascular · 309d
Cleared Apr 13, 2019
INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy...
K190690 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 26d
Cleared Apr 12, 2019
Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter
K183599 · OGZ
Infraredx, Inc.
Cardiovascular · 107d
Cleared Apr 12, 2019
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface,...
K183490 · DTZ
Medtronic, Inc.
Cardiovascular · 116d
Cleared Apr 12, 2019
KardiaMobile, KardiaStation
K182396 · DXH
AliveCor, Inc.
Cardiovascular · 220d
Cleared Apr 10, 2019
Confirm Rx Insertable Cardiac Monitor
K190295 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 58d
Cleared Apr 10, 2019
S-MAK XL
K190175 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 68d
Cleared Apr 09, 2019
Pantheris SV
K182341 · MCW
Avinger, Inc.
Cardiovascular · 224d
Cleared Apr 09, 2019
Transtek Blood Pressure Monitor
K181832 · DXN
Guangdong Transtek Medical...
Cardiovascular · 274d
Cleared Apr 05, 2019
Amplatzer Trevisio Intravascular Delivery System
K190581 · DQY
Abbott Medical
Cardiovascular · 30d
Cleared Apr 05, 2019
EkoSonic Endovascular Device with Control Unit 4.0
K183361 · QEY
Btg International, Inc.
Cardiovascular · 122d
Cleared Apr 05, 2019
Patient Monitor
K181919 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 261d
Cleared Apr 04, 2019
Park Blade Septostomy Catheter
K182399 · DXF
Cook Incorporated
Cardiovascular · 212d
Cleared Apr 04, 2019
GMC Upper Arm Automatic Blood Pressure Monitor
K181931 · DXN
Gmc, Inc.
Cardiovascular · 260d
Cleared Apr 03, 2019
Bio-Medicus Insertion Kit
K190557 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Apr 02, 2019
AcQMap High Resolution Imaging and Mapping System
K190131 · DQK
Acutus Medical, Inc.
Cardiovascular · 64d
Cleared Apr 02, 2019
Ilumien Optis, Optis Integrated, Optis Mobile
K183320 · NQQ
St. Jude Medical (Now Abbott Medical)
Cardiovascular · 123d
Cleared Mar 29, 2019
Confirm Rx Insertable Cardiac Monitor
K182981 · MXC
Abbott
Cardiovascular · 151d