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
2305–2328 of 18,182
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 CT 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