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
1–24 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 30, 2026
Arctic Sun™ Neonatal ArcticGel™ Pad
K263587 · DWJ
Medivance, Inc.
Cardiovascular · 30d
Cleared Oct 30, 2026
AngioVac F1885
K263076 · DWF
AngioDynamics, Inc.
Cardiovascular · 59d
Cleared Oct 30, 2026
EXG PulseLinQ Cables (EXGPL)
K262816 · DSA
Cb Innovations, LLC
Cardiovascular · 84d
Cleared Oct 30, 2026
VIVO (9002)
K261886 · DQK
Catheter Precision, Inc.
Cardiovascular · 147d
Cleared Oct 29, 2026
VasQ
K263598 · QVQ
Laminate Medical Technologies
Cardiovascular · 29d
Cleared Oct 29, 2026
DLP™ Coronary Ostial Cannulae
K263596 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Oct 29, 2026
Cleerly ISCHEMIA
K262839 · QXZ
Cleerly, Inc.
Cardiovascular · 79d
Cleared Oct 28, 2026
Evident Vascular™ Guidance System
K261648 · IYO
Evident Vascular, Inc.
Cardiovascular · 163d
Cleared Oct 28, 2026
YUWELL® Electronic Blood Pressure Monitor
K260670 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 240d
Cleared Oct 27, 2026
FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors
K261714 · DPW
Transonic Systems, Inc.
Cardiovascular · 154d
Cleared Oct 27, 2026
Nimbl™ Pneumatic Compression System
K260586 · JOW
Tactile Medical
Cardiovascular · 249d
Cleared Oct 27, 2026
PulseAPI SmartWatch
K254226 · DQK
PulseAI, Ltd.
Cardiovascular · 302d
Cleared Oct 26, 2026
FLOWRUNNER Aspiration System
K262864 · QEZ
Expanse Medical, Inc.
Cardiovascular · 73d
Cleared Oct 23, 2026
STAR Apollo™ Mapping System
K263380 · DQK
Rhythm AI, Ltd.
Cardiovascular · 29d
Cleared Oct 23, 2026
DLP PVC Left Heart Vent
K261792
Medtronic
Cardiovascular · 147d
Cleared Oct 23, 2026
Kinetic Software Library
K260640 · DPS
Monebo Technologies, Inc.
Cardiovascular · 238d
Cleared Oct 22, 2026
Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter
K260686 · PNO
Zylox Medtech Co., Ltd.
Cardiovascular · 233d
Cleared Oct 21, 2026
ACHM30 AtriClip FLEX-Mini LAA Exclusion System
K263319 · PZX
AtriCure, Inc.
Cardiovascular · 30d
Cleared Oct 21, 2026
Hemotag Analysis Software (HAS)
K252736 · DQD
Aventusoft, LLC
Cardiovascular · 419d
Cleared Oct 19, 2026
Reprocessed BRK Transseptal Needle
K262917 · NMK
Innovative Health, LLC
Cardiovascular · 60d
Cleared Oct 16, 2026
Sensinel Cardiopulmonary Management (CPM) System
K260801 · MWI
Analog Devices
Cardiovascular · 219d
Cleared Oct 16, 2026
Small Diameter Core Wire (CMAN-000-00)
K260168 · DQX
Skycade Med Corporation
Cardiovascular · 269d
Cleared CT Oct 15, 2026
INDIGO® Aspiration System
K262904 · QEW
Penumbra, Inc.
Cardiovascular · 58d
Cleared Oct 15, 2026
Giranel Guiding Sheath Set
K262674 · DYB
Kossel Medtech (Suzhou) Co., Ltd.
Cardiovascular · 77d