Medical Device Manufacturer · US , South Jordan , UT

Merit Medical Systems, Inc. - FDA 510(k) Cleared Devices

178 submissions · 170 cleared · Since 1988

Recent clearances: StatSeal Disc, STAR RF Ablation System, SCOUT MD Surgical Guidance System

Official Website

178

Total

170

Cleared

0

Denied

FDA 510(k) Regulatory Record - Merit Medical Systems, Inc. General Hospital ✕

16 devices

1-12 of 16

Cleared Nov 04, 2025

General Hospital · 228d

Cleared Nov 06, 2018

General Hospital · 83d

Cleared Nov 06, 2018

General Hospital · 76d

Cleared Jan 31, 2018

General Hospital · 71d

Cleared Aug 07, 2017

General Hospital · 90d

Cleared Jul 27, 2017

VacLok AT Vacuum Syringe

General Hospital · 218d

Cleared Dec 07, 2015

Merit 20 mL Syringe

General Hospital · 73d

Cleared Oct 17, 2014

Merit 10mL Syringe

General Hospital · 30d

Cleared Jun 24, 2011

MERIT MEDICAL 20 ML SYRINGE

General Hospital · 66d

Cleared Dec 23, 2008

MISER CONTRAST MANAGEMENT SYSTEM

General Hospital · 20d

Cleared Feb 21, 2003

MERIT MEDICAL 1-ML SYRINGE

General Hospital · 77d

Cleared Jan 05, 2000

General Hospital · 19d