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
2281–2304 of 18,110
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