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
73–96 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 17, 2026
Amplatzer TorqVue Exchange System
K261631 · DQY
Abbott Medical
Cardiovascular · 30d
Cleared Jun 16, 2026
VicorderCS (VCS-SYS-1100)
K260693 · DXN
80 Beats Medical GmbH
Cardiovascular · 105d
Cleared Jun 15, 2026
VERAFEYE Imaging and Guidance System (VF-VIS-002)
K260885
Luma Vision Limited
Cardiovascular · 90d
Cleared Jun 15, 2026
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
K253059 · DXN
Tournicare Pty, Ltd.
Cardiovascular · 266d
Cleared Jun 12, 2026
HARBOR Occlusion Device
K260635 · KRD
Nuvascular, Inc.
Cardiovascular · 106d
Cleared Jun 12, 2026
Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300,...
K253196 · MWI
Midmark Corporation
Cardiovascular · 259d
Cleared Jun 12, 2026
OneStim-DUO Cardiac Stimulator (MP5003-4CO)
K253088 · DQK
Micropace Pty, Ltd.
Cardiovascular · 262d
Cleared Jun 11, 2026
Verge™ Microcatheter
K261610 · KRA
Instylla, Inc.
Cardiovascular · 28d
Cleared Jun 11, 2026
Anura Mobile Core SDK (M1)
K253650 · QME
Nuralogix Corporation
Cardiovascular · 203d
Cleared Jun 10, 2026
Intra-Operative Positioning System (IOPS) (MC-1)
K261329 · DQK
Centerline Biomedical
Cardiovascular · 49d
Cleared Jun 08, 2026
EchoNext
K260332 · QXO
Pathwai, Inc.
Cardiovascular · 126d
Cleared Jun 05, 2026
FieldFlex Steerable Sheath
K261492 · DYB
CenterPoint Systems, LLC
Cardiovascular · 30d
Cleared Jun 05, 2026
Perfect-O Ostial Positioning Catheter
K260289 · DQY
Balosmark, Inc.
Cardiovascular · 127d
Cleared Jun 05, 2026
Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
K260105 · DXC
Edwards Lifesciences
Cardiovascular · 143d
Cleared Jun 04, 2026
Radius VSM and Accessories
K254209 · MHX
Masimo Corporation
Cardiovascular · 157d
Cleared Jun 03, 2026
Upper arm electronic blood pressure monitor (XB-01)
K253124 · DXN
Shenzhen Ziqing Medical Equipment...
Cardiovascular · 251d
Cleared May 29, 2026
ZEUS Platform (FG0501US)
K252859 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 262d
Cleared May 29, 2026
M12 Telemetry System
K252840 · MHX
Global Instrumentation, LLC
Cardiovascular · 266d
Cleared May 28, 2026
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF,...
K252702 · DQO
Bioptimal International Pte. , Ltd.
Cardiovascular · 274d
Cleared May 22, 2026
InQwire Amplatz Guide Wire
K254137 · DQX
Merit Medical Ireland, Ltd.
Cardiovascular · 151d
Cleared May 22, 2026
ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
K252917 · PZX
Genesee Biomedical, Inc.
Cardiovascular · 252d
Cleared May 22, 2026
AiSteth®
K252915 · DQD
Ai Health Highway India Pvt., Ltd.
Cardiovascular · 252d
Cleared May 22, 2026
Arc Adjustable Radial Cuff Compression Device
K252772 · DXC
Tz Medical, Inc.
Cardiovascular · 262d
Not Cleared May 22, 2026
PCWP Analysis Software
DEN250057 · SIF
Cardiosense, Inc.
Cardiovascular · 186d