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
2521–2544 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 10, 2018
physiQ Heart Rhythm Module
K180234 · DPS
Physiq, Inc.
Cardiovascular · 193d
Cleared Aug 09, 2018
Presygen/si-1
K171245 · MUD
Christie Medical Holdings, Inc.
Cardiovascular · 468d
Cleared Aug 08, 2018
4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F &...
K181836 · DQO
Cordis, A Cardinal Health Company
Cardiovascular · 29d
Cleared Aug 08, 2018
Pure EP
K180805 · DQK
Biosig Technologies
Cardiovascular · 133d
Cleared Aug 08, 2018
SmartLinx Vitals Plus Patient Monitoring System
K180734 · MWI
Capsule Technologie
Cardiovascular · 141d
Cleared Aug 07, 2018
VascuEase IC-1200-WH
K180248 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 190d
Cleared Aug 05, 2018
VesoFlow Lite DVT Compression Device
K181217 · JOW
Caremed Supply, Inc.
Cardiovascular · 90d
Cleared Aug 03, 2018
Atlas Gold PTA Dilatation Catheter
K181323 · LIT
C.R. Bard, Inc.
Cardiovascular · 77d
Cleared CT Aug 03, 2018
Glidesheath Slender Tibial Pedal Kit
K181237 · DYB
Terumo Medical Corporation
Cardiovascular · 85d
Cleared Aug 03, 2018
Arm Type Blood Pressure Monitor
K180155 · DXN
Avita Corporation
Cardiovascular · 196d
Cleared Aug 03, 2018
ECG recorder and Arrhythmia Detector
K173461 · DSH
Smart Solutions Technologies SL
Cardiovascular · 269d
Cleared Aug 02, 2018
Temporary Cardiac Pacing Wire
K173923 · LDF
Ethicon, Inc.
Cardiovascular · 219d
Cleared Aug 02, 2018
Med-link Reusable Blood Pressure Cuff
K173869 · DXQ
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 225d
Cleared Jul 30, 2018
Epiphany Cardio Server Mobile
K181720 · DQK
Epiphany Healthcare, LLC
Cardiovascular · 31d
Cleared Jul 27, 2018
FlowTriever Retrieval/Aspiration System
K181694 · QEW
Inari Medical
Cardiovascular · 30d
Cleared Jul 26, 2018
RadialSeal Introducer Kit
K181855 · DYB
Great Batch Medical
Cardiovascular · 15d
Cleared Jul 26, 2018
Level 1 Convective Warmer
K181699 · DWJ
Smiths Medical Asd, Inc.
Cardiovascular · 29d
Cleared Jul 26, 2018
Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter,...
K180958 · PPN
Shockwave Medical, Inc.
Cardiovascular · 105d
Cleared Jul 26, 2018
Vios Central Station Monitor Software, Vios Central Server Software
K173107 · DXJ
Vios Medical, Inc.
Cardiovascular · 300d
Cleared Jul 25, 2018
RHYTHMIA HDx Mapping System (with software Version 2.0)
K173837 · DQK
Boston Scientific Corporation
Cardiovascular · 219d
Cleared Jul 24, 2018
MX40 Release C.01
K180017 · MHX
Philips Medical Systems
Cardiovascular · 203d
Cleared Jul 24, 2018
CipherOx CRI M1
K173929 · PPW
Flashback Technologies, Inc.
Cardiovascular · 210d
Cleared Jul 24, 2018
Portable ECG Monitor (ECG3)
K172862 · DSH
Andon Health Co, Ltd.
Cardiovascular · 307d
Cleared Jul 20, 2018
Bandit guidewire
K181647 · DQX
Vascular Solutions, Inc.
Cardiovascular · 28d