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
1057–1080 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 14, 2023
CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)
K223290 · LLZ
Sentiar, Inc.
Cardiovascular · 261d
Cleared Jul 13, 2023
Micro Rx
K223728 · DQY
Imds Operations B.V.
Cardiovascular · 212d
Cleared Jul 12, 2023
FusedCO Algorithm
K231035 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 92d
Cleared Jul 12, 2023
AusculThing ACC
K230823 · DQD
Ausculthing OY
Cardiovascular · 110d
Cleared Jul 10, 2023
CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S,...
K231412 · DYB
Biosense Webster, Inc.
Cardiovascular · 55d
Cleared Jul 10, 2023
PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter,...
K231312 · MTD
Biosense Webster, Inc.
Cardiovascular · 66d
Cleared Jul 10, 2023
AcQMap High Resolution Imaging and Mapping System
K231091 · DQK
Acutus Medical, Inc.
Cardiovascular · 84d
Cleared Jul 07, 2023
T3 Platform software
K223578 · PPW
Etiometry, Inc.
Cardiovascular · 219d
Cleared Jul 06, 2023
ARGUS PB-3000
K221056 · MHX
Schiller AG
Cardiovascular · 451d
Cleared Jul 05, 2023
Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter...
K231279 · KRA
Ablative Solutions, Inc.
Cardiovascular · 63d
Cleared Jul 03, 2023
BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter
K231653 · QEY
Thrombolex, Inc.
Cardiovascular · 27d
Cleared Jun 30, 2023
IOB Temperature Management System
K231596 · DWJ
Iob Medical, Inc.
Cardiovascular · 29d
Cleared Jun 30, 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K231588 · OWQ
Abbott Medical
Cardiovascular · 29d
Cleared Jun 30, 2023
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide...
K230156 · DQY
Medtronic Vascular
Cardiovascular · 162d
Cleared Jun 30, 2023
Blood Pressure Monitor
K223374 · DXN
Guangdong Transtek Medical...
Cardiovascular · 238d
Cleared Jun 30, 2023
preCARDIA Occlusion System
K221294 · MJN
Abiomed, Inc.
Cardiovascular · 422d
Cleared Jun 29, 2023
HotDog Warming Mattress + Return Electrode
K230866 · DWJ
Augustine Temperature Management, LLC
Cardiovascular · 92d
Cleared Jun 29, 2023
Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation...
K230374 · LOX
Dongguan TT Medical, Inc.
Cardiovascular · 136d
Cleared Jun 29, 2023
Upper Arm Blood Pressure Monitor
K230176 · DXN
Shenzhen Yolanda Technology Co., Ltd.
Cardiovascular · 157d
Cleared Jun 28, 2023
Aneroid Sphygmomanometer
K230859 · DXQ
Wenzhou Kangshun Medical Devices Co.,Ltd
Cardiovascular · 91d
Cleared Jun 28, 2023
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K
K230075 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 169d
Cleared Jun 27, 2023
EMBOLD™ Soft Detachable Coil System
K230706 · KRD
Boston Scientific Corporation
Cardiovascular · 105d
Cleared Jun 23, 2023
GORE® ACUSEAL Vascular Graft
K231505 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 30d
Cleared Jun 23, 2023
AccurECG Analysis System
K223013 · DPS
Accurkardia, Inc.
Cardiovascular · 267d