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
25–48 of 18,110
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 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 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