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
145–168 of 18,182
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