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
2593–2616 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 25, 2018
Quantum Pump Console
K173834 · DTQ
Spectrum Medical , Ltd.
Cardiovascular · 158d
Cleared May 25, 2018
STAR 65
K172147 · MWI
Skanray Technologies Pvt, Ltd.
Cardiovascular · 312d
Cleared May 23, 2018
Route 92 Medical Access System
K180201 · DQY
Route 92 Medical, Inc.
Cardiovascular · 119d
Cleared May 22, 2018
Pantheris System
K173862 · MCW
Avinger, Inc.
Cardiovascular · 153d
Cleared May 18, 2018
The IQoolTM Warm System
K180375 · DWJ
Braincool AB
Cardiovascular · 95d
Cleared May 17, 2018
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
K181042 · DXK
Boston Scientific Corporation
Cardiovascular · 28d
Cleared May 17, 2018
Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon...
K181023 · LOX
Meril Life Sciences Private Limited
Cardiovascular · 30d
Cleared May 17, 2018
EnsoETM
K180742 · PLA
Advanced Cooling Therapy, Inc. D/B/A...
Cardiovascular · 56d
Cleared CT May 17, 2018
FlowTriever Retrieval/Aspiration System
K180466 · QEW
Inari Medical, Inc.
Cardiovascular · 85d
Cleared May 15, 2018
XableCath Support Catheter Product Family
K180986 · DQY
Xablecath, Inc.
Cardiovascular · 29d
Cleared May 15, 2018
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and...
K180412 · QEW
Penumbra, Inc.
Cardiovascular · 89d
Cleared CT May 11, 2018
µCor Heart Failure and Arrhythmia Management System
K172510 · MHX
Zoll Manufacturing Corporation
Cardiovascular · 263d
Cleared May 10, 2018
FORE-SIGHT ELITE Module Tissue Oximeter
K180003 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 128d
Cleared May 10, 2018
ANGIO-PRESS LITE DVT Compression Device
K173012 · JOW
Pegasus Medical Supply, Inc.
Cardiovascular · 225d
Cleared May 09, 2018
VSI Micro-Introducer Kit
K180913 · DYB
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared May 08, 2018
Glidesheath Slender
K173831 · DYB
Terumo Medical Corporation
Cardiovascular · 141d
Cleared May 08, 2018
BioStamp nPoint
K173510 · DRG
Mc10, Inc.
Cardiovascular · 176d
Cleared May 04, 2018
QT ECG
K180157 · DXH
QT Medical, Inc.
Cardiovascular · 105d
Cleared May 03, 2018
Medtronic Confida Brecker Guidewire
K181001 · DQX
Medtronic Core Valve, LLC
Cardiovascular · 17d
Cleared May 03, 2018
Indigo Aspiration System - Modified 110 Aspiration Tubing
K180939 · QEW
Penumbra, Inc.
Cardiovascular · 23d
Cleared May 03, 2018
Micropuncture Pedal Access Set
K172980 · DYB
Cook Incorporated
Cardiovascular · 218d
Cleared May 01, 2018
PeraServer and PeraTrend
K172959 · MWI
Perahealth, Inc.
Cardiovascular · 217d
Cleared Apr 27, 2018
Novasight Hybrid System
K172258 · OBJ
Conavi Medical, Inc.
Cardiovascular · 275d
Cleared Apr 23, 2018
EnSite Velocity Cardiac Mapping System v5.2
K172396 · DQK
St Jude Medical
Cardiovascular · 258d