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
985–1008 of 18,110
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