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
2449–2472 of 18,110
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 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