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
2425–2448 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 11, 2018
Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope...
K182196 · DQD
Imediplus, Inc.
Cardiovascular · 28d
Not Cleared Sep 11, 2018
ECG App
DEN180044 · QDA
Apple, Inc.
Cardiovascular · 28d
Not Cleared Sep 11, 2018
Irregular Rhythm Notification Feature
DEN180042 · QDB
Apple, Inc.
Cardiovascular · 33d
Cleared Sep 07, 2018
Philips Hemodynamic Application R1.0
K181311 · MWI
Philips Medical Systems Nederlands B.V.
Cardiovascular · 113d
Cleared Sep 06, 2018
Paladin Carotid Post-dilation Balloon System with Integrated Embolic...
K181128 · LIT
Contego Medical, LLC
Cardiovascular · 129d
Cleared Sep 04, 2018
IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3,...
K181314 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 110d
Cleared Sep 04, 2018
Surveyor Patient Monitor
K173765 · MHX
Mortara Instrument, Inc.
Cardiovascular · 267d
Cleared Aug 29, 2018
Zio AT ECG Monitoring System, ZEUS System
K181502 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 83d
Cleared Aug 29, 2018
Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic...
K181104 · DXN
Shenzhen Combei Technology Co., Ltd.
Cardiovascular · 125d
Cleared Aug 28, 2018
Universal SmartECG
K173952 · DPS
Vectracor, Inc.
Cardiovascular · 244d
Cleared Aug 24, 2018
NC TREK™ RX Coronary Dilatation Catheter
K180040 · LOX
Abbott Vascular
Cardiovascular · 231d
Cleared Aug 24, 2018
CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER...
K173978 · DQK
Biosense Webster, Inc.
Cardiovascular · 238d
Cleared Aug 22, 2018
autoLog IQ Autotransfusion System
K181954 · CAC
Medtronic Perfusion Systems
Cardiovascular · 30d
Cleared Aug 22, 2018
Non-invasive blood pressure measurement systems
K173024 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 328d
Cleared Aug 21, 2018
Medtronic Model 5392 External Pulse Generator (EPG)
K181973 · DTE
Medtronic, Inc.
Cardiovascular · 28d
Cleared Aug 21, 2018
exGraft, exGraft Carbon ePTFE Vascular Grafts
K180957 · DSY
Peca Labs
Cardiovascular · 131d
Cleared Aug 21, 2018
Reusable NIBP Cuff
K173197 · DXQ
Orantech, Inc.
Cardiovascular · 323d
Cleared Aug 17, 2018
Quantum Workstation 12.1
K181923 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 30d
Cleared Aug 17, 2018
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD...
K173773 · DXT
Bayer Medical Care, Inc.
Cardiovascular · 248d
Cleared Aug 17, 2018
Electronic Stethoscope DS3011A
K173663 · DQD
Imediplus, Inc.
Cardiovascular · 261d
Cleared Aug 16, 2018
Multi-parameter Patient Monitor, models C30
K173454 · MHX
Shenzhen Comen Medical Instruments...
Cardiovascular · 283d
Cleared Aug 15, 2018
RAIN Sheath Transradial
K181592 · DYB
Cordis Corporation
Cardiovascular · 58d
Cleared Aug 11, 2018
CARDIOSKIN
K173248 · DXH
Bioserenity Sas
Cardiovascular · 305d
Cleared Aug 10, 2018
Altrix Precision Temperature Management System
K180834 · DWJ
Stryker Medical
Cardiovascular · 133d