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Merit Medical Systems, Inc. FDA Approvals
0 new drug approvals and 28 device clearances on file. Matched by name to MMSI.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| FlexTract Deflectable-Rotational Dilator Sheath Set510(k)Jul 27, 2026Cardiovascular |
| PreludeSYNC Radial Compression Device510(k)Jul 22, 2026Cardiovascular |
| StatSeal Disc510(k)May 13, 2026 |
| STAR RF Ablation System510(k)Feb 13, 2026Neurology |
| SCOUT MD Surgical Guidance System510(k)Dec 19, 2025General, Plastic Surgery |
| Merit Syringe510(k)Nov 4, 2025General Hospital |
| Resilience Fully Covered Esophageal Stent System510(k)Jul 23, 2025General, Plastic Surgery |
| Prelude Wave Hydrophilic Sheath Introducer510(k)Apr 25, 2025Cardiovascular |
| Ventrax Delivery System510(k)Jan 15, 2025Cardiovascular |
| Micro Ace Gold Advanced Micro Access System510(k)Jan 15, 2025Cardiovascular |
| Prelude Small O.D. Introducer Guide Wire510(k)Dec 10, 2024Cardiovascular |
| Impress Angiographic Catheter510(k)May 22, 2024Cardiovascular |
| Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)510(k)May 2, 2024Cardiovascular |
| Bearing nsPVA Express510(k)Dec 21, 2023Cardiovascular |
| Mighty Wire Guide Wire510(k)Oct 28, 2023Cardiovascular |
| Micro Ace Advanced Micro Access System510(k)Sep 27, 2023Cardiovascular |
| Ventrax Delivery System (VTR851)510(k)Aug 30, 2023Cardiovascular |
| Aspira Pleural Drainage System510(k)Mar 3, 2023Cardiovascular |
| Low Profile Companion Sheath510(k)Jan 19, 2023Cardiovascular |
| HeRO Graft510(k)Aug 15, 2022Cardiovascular |
| SCOUT BX Delivery System510(k)Apr 8, 2022General, Plastic Surgery |
| Elation Pulmonary Balloon Dilation Catheter510(k)Mar 8, 2022Ear, Nose, Throat |
| Aspira Peritoneal Drainage System510(k)Dec 14, 2021Gastroenterology, Urology |
| ASAP Aspiration Catheter, ASAPLP Aspiration Catheter510(k)Nov 3, 2021Cardiovascular |
| Prelude Guide Sheath510(k)Oct 4, 2021Cardiovascular |
| SwiftNINJA Steerable Microcatheter510(k)Jul 16, 2021Cardiovascular |
| HeRO Graft, HeRO Adapter510(k)May 25, 2021Cardiovascular |
| Cultura Collection and Transport System510(k)Mar 3, 2021Microbiology |