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
265–288 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 09, 2026
Peel-Away Introducer Sheath
K254236 · DYB
VascuTech Medical, LLC
Cardiovascular · 42d
Cleared Feb 09, 2026
Holter ECG and ABP system (HolterABP)
K251591 · DQK
Edan Instruments, Inc.
Cardiovascular · 262d
Cleared Feb 06, 2026
IntelliVue Multi-Measurement Module X3 (867030)
K252726 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 162d
Cleared Feb 06, 2026
Kneevoice Cartilage Evaluation System (750-3600-001)
K252076 · DQD
Kneevoice, Inc.
Cardiovascular · 219d
Cleared Feb 06, 2026
SafeBeat Rx App
K251218 · DQK
Safebeat Rx, Inc.
Cardiovascular · 291d
Cleared Feb 05, 2026
CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with...
K260028 · QEW
Argon Medical Devices, Inc.
Cardiovascular · 31d
Cleared Feb 05, 2026
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
K251949 · QEW
Penumbra, Inc.
Cardiovascular · 225d
Cleared Feb 04, 2026
UltraScore™ Focused Force PTA Balloon
K260012 · PNO
Bard Peripheral Vascular, Inc.
Cardiovascular · 30d
Cleared Feb 03, 2026
The Circadia C300 System (C300)
K252676 · DRT
Circadia Health, Inc.
Cardiovascular · 162d
Cleared Feb 02, 2026
Vital Signs
K251200 · QME
Oxehealth Limited
Cardiovascular · 290d
Cleared Jan 31, 2026
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
K253847 · DQX
Merit Medical Ireland, Ltd.
Cardiovascular · 60d
Cleared Jan 30, 2026
Dual Stage Venous Cannulae
K253671 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 70d
Cleared Jan 28, 2026
Vena MicroAngioscope™ System
K253842 · LYK
Vena Medical Holdings Corp
Cardiovascular · 57d
Cleared Jan 28, 2026
Sleepiz One+ (Model 2.5)
K253388 · DRT
Sleepiz AG
Cardiovascular · 120d
Cleared Jan 28, 2026
NorthStar™ Mapping System
K252164 · DQK
Imricor Medical Systems
Cardiovascular · 202d
Cleared Jan 26, 2026
MAC 7 Resting ECG Analysis System
K251670 · DPS
Ge Medical Systems Information...
Cardiovascular · 241d
Cleared Jan 23, 2026
BodyGuardian Remote Monitoring System (BGRMS v3.0)
K243349 · DSI
Boston Scientific Cardiac Diagnostic...
Cardiovascular · 452d
Cleared Jan 22, 2026
Genie MAX Large Bore Introducer Sheath
K253652 · DYB
Cultiv8 1, LLC
Cardiovascular · 63d
Cleared Jan 22, 2026
Perin Health System (PHD80060-2)
K252984 · DRG
Perin Health Devices, LLC
Cardiovascular · 126d
Cleared Jan 21, 2026
RoVo Mechanical Thrombectomy System
K253730 · QEW
Verge Medical, Inc.
Cardiovascular · 58d
Cleared Jan 21, 2026
InQwire Super Stiff Guide Wire (IQSS32180J3)
K251385 · DQX
Merit Medical Ireland, Ltd.
Cardiovascular · 261d
Cleared Jan 20, 2026
Clearview Intracoronary Shunts
K253998 · DWF
Medtronic, Inc.
Cardiovascular · 39d
Cleared Jan 20, 2026
VariFuse Adjustable Infusion Catheter
K251318 · QEY
Argon Medical Devices, Inc.
Cardiovascular · 266d
Cleared Jan 18, 2026
Baylis Connector Cable
K254114 · DSA
Baylis Medical Technologies, Inc.
Cardiovascular · 30d