Merit Medical Systems, Inc.
FDA 510(k) & PMA Approved Devices — 67 products
Total Devices67
Categories31
Latest FDA decision2026-07-27
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set | DRE | 2026-07-27 | View |
| 510(k) | K262086 | PreludeSYNC™ Radial Compression Device | DXC | 2026-07-22 | View |
| PMA | P240023 | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment | PFV | 2026-06-11 | View |
| 510(k) | K254073 | StatSeal Disc | FRO | 2026-05-13 | View |
| 510(k) | K251802 | STAR RF Ablation System | GXI | 2026-02-13 | View |
| 510(k) | K252892 | SCOUT MD Surgical Guidance System | NEU | 2025-12-19 | View |
| 510(k) | K250853 | Merit Syringe | FMF | 2025-11-04 | View |
| 510(k) | K251265 | Resilience Fully Covered Esophageal Stent System | ESW | 2025-07-23 | View |
| 510(k) | K250909 | Prelude Wave Hydrophilic Sheath Introducer | DYB | 2025-04-25 | View |
| 510(k) | K242229 | Micro Ace Gold Advanced Micro Access System | DRE | 2025-01-15 | View |
| 510(k) | K242873 | Ventrax™ Delivery System | DQY | 2025-01-15 | View |
| 510(k) | K241521 | Prelude Small O.D. Introducer Guide Wire | DQX | 2024-12-10 | View |
| 510(k) | K233268 | Impress Angiographic Catheter | DQO | 2024-05-22 | View |
| 510(k) | K240261 | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) | KRD | 2024-05-02 | View |
| 510(k) | K233813 | Bearing nsPVA Express™ | NAJ | 2023-12-21 | View |
| 510(k) | K230418 | Mighty Wire Guide Wire | DQX | 2023-10-28 | View |
| 510(k) | K232609 | Micro Ace™ Advanced Micro Access System | DRE | 2023-09-27 | View |
| 510(k) | K231246 | Ventrax™ Delivery System (VTR851) | DQY | 2023-08-30 | View |
| 510(k) | K212696 | Aspira Pleural Drainage System | DWM | 2023-03-03 | View |
| 510(k) | K223872 | Low Profile Companion Sheath | DYB | 2023-01-19 | View |
No matching devices.
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Related Clinical Trials
NCT03311451C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.ACTIVE_NOT_RECRUITINGNCT04540302The Merit WRAPSODY AV Access Efficacy Study (WAVE)COMPLETEDNCT05050799US Post-Market Surveillance Study of the Surfacer SystemRECRUITINGNCT06153667Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)RECRUITINGNCT06422871PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on HemodialysisRECRUITINGNCT06587282PREEMIE: Study for Treatment of PDA in Premature InfantsACTIVE_NOT_RECRUITINGNCT06807099WRAP North AmericaRECRUITING