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
25–48 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 15, 2026
The Circadia CX00 System (CX00)
K262447 · DRT
Circadia Health, Inc.
Cardiovascular · 91d
Cleared Oct 14, 2026
Radius VSM and Accessories
K260676 · MHX
Masimo Corporation
Cardiovascular · 226d
Cleared CT Oct 11, 2026
Helo™ Return
K253717 · SHJ
Endovascular Engineering, Inc.
Cardiovascular · 321d
Cleared Oct 09, 2026
Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)
K262068 · DRF
CathRx, Ltd.
Cardiovascular · 109d
Cleared Oct 07, 2026
eClinics
K260075 · MSX
Ceiba Healthcare US, Inc.
Cardiovascular · 268d
Cleared Oct 06, 2026
LOBO Vascular Occlusion System
K262798 · KRD
Okami Medical, Inc.
Cardiovascular · 60d
Cleared Oct 05, 2026
MyoVista wavECG (DG-200-B15-003)
K260005 · DPS
HeartSciences, Inc.
Cardiovascular · 276d
Cleared Oct 01, 2026
Dual Stage Venous Cannulae
K263092 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 28d
Cleared Oct 01, 2026
Intra-Operative Positioning System (IOPS) and IOPS Visionary System
K263016 · DQK
Centerline Biomedical
Cardiovascular · 34d
Cleared Oct 01, 2026
Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C,...
K260470 · DXN
Shenzhen Brav Electronic Technologies...
Cardiovascular · 231d
Cleared Sep 30, 2026
ECG Analysis Software (AiTiALVSD)
K254302 · QYE
Medical AI Co., Ltd.
Cardiovascular · 273d
Cleared Sep 29, 2026
Elucid FFR-IQ (B.1)
K262015 · PJA
Elucid Bioimaging, Inc.
Cardiovascular · 106d
Cleared Sep 29, 2026
QCA 10 Electrocardiograph (QCARD-10)
K260250 · DPS
QT Medical, Inc.
Cardiovascular · 245d
Not Cleared Sep 29, 2026
SmartRead(TM) Medical Device Identifier (4100)
DEN260007 · SJJ
BridgeSource Medical Corporation
Cardiovascular · 189d
Cleared Sep 28, 2026
Tri Stage Venous Cannulae
K262052 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 102d
Cleared Sep 25, 2026
Tempus ECG-MR
K254297 · SBQ
Tempus AI, Inc.
Cardiovascular · 268d
Cleared Sep 25, 2026
S-Patch CardioAI
K254255 · DPS
Wellysis Corp.
Cardiovascular · 270d
Cleared Sep 25, 2026
DistaSense(TM) (v1)
K254058 · DRT
Life Detection Technologies
Cardiovascular · 282d
Cleared Sep 22, 2026
Echo-2
K254240 · QOK
Neko Health AB
Cardiovascular · 267d
Cleared Sep 21, 2026
KARL STORZ TIPCAM1 Rubina
K262547 · OWN
KALR STORZ SE & Co. KG
Cardiovascular · 60d
Cleared Sep 21, 2026
ZYLOX Hippo PTA Balloon Dilatation Catheter
K260416 · LIT
Zylox Medtech Co., Ltd.
Cardiovascular · 224d
Cleared Sep 21, 2026
TriSalus TriNav Advance Infusion System
K253509 · KRA
Trisalus Life Sciences
Cardiovascular · 320d
Cleared Sep 18, 2026
CrossFAST Integrated Microcatheter Advanced Delivery System
K262817 · DQY
Vantis Vascular, Inc.
Cardiovascular · 42d
Cleared Sep 18, 2026
Deterioration Index Version 2
K260008 · QNL
Epic Systems Corporation
Cardiovascular · 259d