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
2353–2376 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 11, 2019
KardiaAI
K181823 · DQK
AliveCor, Inc.
Cardiovascular · 245d
Cleared Mar 07, 2019
iSLEEVE Introducer Set
K190184 · DYB
Boston Scientific
Cardiovascular · 34d
Cleared Mar 07, 2019
Endophys Pressure Sensing Sheath
K190098 · DYB
Endophys Holdings, LLC
Cardiovascular · 44d
Cleared Mar 07, 2019
VitalConnect Platform, VitalPatch Biosensor
K183078 · DRG
Vitalconnect, Inc.
Cardiovascular · 122d
Cleared Mar 07, 2019
RhythmAnalytics
K182344 · DQK
Biofourmis Singapore Pte., Ltd.
Cardiovascular · 191d
Cleared Mar 07, 2019
Philips wearable biosensor-G5 Solution
K181165 · DRT
Connected Sensing- A Division of...
Cardiovascular · 309d
Cleared Mar 03, 2019
Electronic Blood Pressure Monitor
K182495 · DXN
Shenzhen Jumper Medical Equipment...
Cardiovascular · 173d
Cleared Mar 01, 2019
EP-TRACER System
K183266 · DQK
Schwarzer Cardiotek GmbH
Cardiovascular · 98d
Not Cleared Mar 01, 2019
Early Bird Bleed Monitoring System
DEN180021 · QFJ
Saranas, Inc.
Cardiovascular · 312d
Cleared Feb 28, 2019
QUANTIEN Measurement System
K183099 · DQK
St. Jude Medical (Now Abbott Medical)
Cardiovascular · 113d
Cleared Feb 28, 2019
Lifetech Cardio Model 8301 Temporary Pacemaker
K182839 · DTE
Shenzhen Lifetech Cardio Medical...
Cardiovascular · 142d
Cleared Feb 28, 2019
ReDS System
K180479 · DSB
Sensible Medical Innovations , Ltd.
Cardiovascular · 371d
Cleared Feb 27, 2019
FlowMet-R
K182494 · DPW
Laser Associated Sciences, Inc.
Cardiovascular · 169d
Cleared Feb 27, 2019
Lympha Press Optimal Plus
K182003 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 216d
Cleared Feb 25, 2019
COBRA Fusion Ablation System
K190151 · OCL
AtriCure, Inc.
Cardiovascular · 26d
Cleared Feb 25, 2019
Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter,...
K183290 · QEY
Thrombolex, Inc.
Cardiovascular · 91d
Cleared Feb 25, 2019
CAPERE Thrombectomy System
K183179 · QEW
Vascular Medcure, Inc.
Cardiovascular · 101d
Cleared Feb 22, 2019
Reprocessed Response Diagnostic Electrophysiology Catheter
K182488 · NLH
Innovative Health, LLC
Cardiovascular · 164d
Cleared Feb 22, 2019
HeartCheck Cardi Beat ECG Monitor with GEMS Mobile
K181310 · DXH
Cardiocomm Solutions, Inc.
Cardiovascular · 281d
Cleared Feb 21, 2019
Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device
K182578 · JOW
Devon Medical Products (Jiangsu), Ltd.
Cardiovascular · 155d
Cleared Feb 16, 2019
RX-1 Rhythm Express Remote Cardiac Monitoring System
K183704 · DXH
Vivaquant, Inc.
Cardiovascular · 47d
Cleared Feb 15, 2019
Lunderquist® Fixed Core Wire Guide
K181353 · DQX
Cook Incorporated
Cardiovascular · 269d
Cleared Feb 14, 2019
PhotoFix Decellularized Bovine Pericardium
K183635 · PSQ
Cryolife, Inc.
Cardiovascular · 50d
Cleared Feb 14, 2019
GMC Wrist Automatic Blood Pressure Monitor
K181930 · DXN
Gmc, Inc.
Cardiovascular · 211d