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
97–120 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 31, 2026
Smart Wireless Stethoscope (STEMO310)
K261494 · DQD
Shanghai Hulu Devices Co., Ltd.
Cardiovascular · 86d
Cleared Jul 31, 2026
VitalFlow Set with Balance™ Biosurface
K261335 · QJZ
Medtronic, Inc.
Cardiovascular · 99d
Cleared Jul 31, 2026
Flexitouch® Plus Advanced Pneumatic Compression System
K253555 · JOW
Tactile Medical
Cardiovascular · 259d
Cleared CT Jul 30, 2026
Sync AV II Temporary Pacing Catheter
K252042 · LDF
Swift Sync, Inc.
Cardiovascular · 395d
Cleared Jul 29, 2026
SSPC NXT Delivery Catheter
K262240 · DQY
CenterPoint Systems, LLC
Cardiovascular · 28d
Cleared Jul 29, 2026
CPS Locator 3D Plus Delivery Catheter
K261766 · DQY
CenterPoint Systems, LLC
Cardiovascular · 62d
Cleared Jul 29, 2026
NAMIC Dilator and Sheath
K253526 · DYB
Medline Industries, LP
Cardiovascular · 258d
Not Cleared Jul 28, 2026
CaRi-Heart
DEN250042 · SIU
Caristo Diagnostics , Ltd.
Cardiovascular · 327d
Cleared Jul 27, 2026
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8...
K262201 · PPN
Shockwave Medical, Inc.
Cardiovascular · 28d
Cleared Jul 27, 2026
Euphora Rapid Exchange (RX) Balloon Dilatation Catheter
K261759 · LOX
Medtronic, Ireland
Cardiovascular · 60d
Cleared Jul 27, 2026
FlexTract Deflectable-Rotational Dilator Sheath Set
K261310 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 97d
Cleared Jul 27, 2026
Powered Aventus Thrombectomy System™
K261105 · QEZ
Inquis Medical
Cardiovascular · 115d
Cleared CT Jul 26, 2026
CorVista System® with PCWP Add-On
K253576 · DQK
Analytics For Life, Inc.
Cardiovascular · 251d
Cleared Jul 24, 2026
FARADRIVE™ Steerable Sheath (M004PF21M402)
K262165 · DRA
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Jul 24, 2026
VERAFEYE Imaging Catheter (VF-VIC-002)
K261849 · OBJ
Luma Vision Limited
Cardiovascular · 51d
Cleared Jul 24, 2026
OBSIDIO Conformable Embolic
K261488 · KRD
Boston Scientific Corporation
Cardiovascular · 79d
Cleared Jul 23, 2026
CORE 300 Digital Stethoscope
K261694 · DQD
Eko Health, Inc.
Cardiovascular · 62d
Cleared Jul 23, 2026
Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)
K261136 · DXN
Guangzhou Daxin Health Technology...
Cardiovascular · 107d
Cleared Jul 23, 2026
Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)
K261082 · DXN
Microlife Corporation
Cardiovascular · 113d
Cleared Jul 22, 2026
PreludeSYNC™ Radial Compression Device
K262086 · DXC
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jul 15, 2026
Aventus Thrombectomy System
K262030 · QEZ
Inquis Medical
Cardiovascular · 28d
Cleared Jul 15, 2026
EnSite™ X EP System
K262006 · DQK
Abbott Medical
Cardiovascular · 30d
Cleared Jul 14, 2026
Accoat Guide Wire
K253667 · DQX
Sp Medical A/S
Cardiovascular · 235d
Cleared Jul 13, 2026
Merit MAK Nitinol/Gold-Tungsten Guide Wire
K261640 · DQX
Merit Medical Ireland, Ltd.
Cardiovascular · 56d