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

180 results for "Merit Medical Systems, Inc."
1–24 of 180
Search insights Median review: 90d Cleared: 100% Top manufacturer: Merit Medical Systems, Inc. Lead specialty: Cardiovascular
Cleared Jul 27, 2026
FlexTract Deflectable-Rotational Dilator Sheath Set
K261310 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 97d
Cleared Jul 22, 2026
PreludeSYNC™ Radial Compression Device
K262086 · DXC
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared May 13, 2026
StatSeal Disc
K254073 · FRO
Merit Medical Systems, Inc.
General & Plastic Surgery · 146d
Cleared Feb 13, 2026
STAR RF Ablation System
K251802 · GXI
Merit Medical Systems, Inc.
Neurology · 246d
Cleared Dec 19, 2025
SCOUT MD Surgical Guidance System
K252892 · NEU
Merit Medical Systems, Inc.
General & Plastic Surgery · 99d
Cleared Nov 04, 2025
Merit Syringe
K250853 · FMF
Merit Medical Systems, Inc.
General Hospital · 228d
Cleared Jul 23, 2025
Resilience Fully Covered Esophageal Stent System
K251265 · ESW
Merit Medical Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 25, 2025
Prelude Wave Hydrophilic Sheath Introducer
K250909 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jan 15, 2025
Ventrax™ Delivery System
K242873 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 114d
Cleared Jan 15, 2025
Micro Ace Gold Advanced Micro Access System
K242229 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 169d
Cleared Dec 10, 2024
Prelude Small O.D. Introducer Guide Wire
K241521 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 195d
Cleared May 22, 2024
Impress Angiographic Catheter
K233268 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 236d
Cleared May 02, 2024
Siege Vascular Plug (SVP2.5-0.021)
K240261 · KRD
Merit Medical Systems, Inc.
Cardiovascular · 92d
Cleared Dec 21, 2023
Bearing nsPVA Express™
K233813 · NAJ
Merit Medical Systems, Inc.
Obstetrics & Gynecology · 21d
Cleared Oct 28, 2023
Mighty Wire Guide Wire
K230418 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 254d
Cleared Sep 27, 2023
Micro Ace™ Advanced Micro Access System
K232609 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Aug 30, 2023
Ventrax™ Delivery System (VTR851)
K231246 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 121d
Cleared Mar 03, 2023
Aspira Pleural Drainage System
K212696 · DWM
Merit Medical Systems, Inc.
Anesthesiology · 555d
Cleared Jan 19, 2023
Low Profile Companion Sheath
K223872 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 27d
Cleared Aug 15, 2022
HeRO Graft
K213845 · DSY
Merit Medical Systems, Inc.
Cardiovascular · 249d
Cleared Apr 08, 2022
SCOUT BX Delivery System
K212882 · NEU
Merit Medical Systems, Inc.
General & Plastic Surgery · 210d
Cleared Mar 08, 2022
Elation Pulmonary Balloon Dilation Catheter
K213434 · KTI
Merit Medical Systems, Inc.
Ear, Nose, Throat · 137d
Cleared Dec 14, 2021
Aspira Peritoneal Drainage System
K212675 · PNG
Merit Medical Systems, Inc.
Gastroenterology & Urology · 112d
Cleared Nov 03, 2021
ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
K212199 · QEZ
Merit Medical Systems, Inc.
Cardiovascular · 112d