# Merit Medical Canada Ltd. (foreign exporter, Markham Ontario, CA): 6 new FDA device listings, incl. dilator, vessel, for percutaneous catheterization

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Merit Medical Canada Ltd. |
| Owner / operator | Merit Medical Systems, Inc. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Markham Ontario, CA |
| New listings | 6 |
| Devices | Dilator, Vessel, For Percutaneous Catheterization; Catheter, Embolectomy; Endoscopic Irrigation/Suction System; Unit, Cryosurgical, Accessories; Endoscopic Access Overtube, Gastroenterology-Urology |
| Product codes | DRE, DXE, OCX, GEH, FED |
| Device classes | Class II |
| Medical specialties | Cardiovascular, Gastroenterology, Urology, General, Plastic Surgery |
| Brand names | Curved Inner Femoral Sheath and Curved Introducer Sheath Set - Femoral.; Needle's Eye Snare Retrieval Set; C2 Cryoballoon Endogrip; C2 Cryoballoon Ablation System; Sidecar External Working Channel (FG-1011) |
| First new listing | 2026-05-08 |
| Latest new listing | 2026-08-20 |
| FDA registration number | 3012536737 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.