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
193–216 of 18,110
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