# Isomedix Operations, Inc. (contract sterilizer, Minneapolis, MN): 12 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories

**Score:** 90/100

| Field | Value |
|---|---|
| Establishment | Isomedix Operations, Inc. |
| Owner / operator | STERIS Corporation |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer); Manufacture Device in the United States for Export Only |
| Location | Minneapolis, MN, US |
| New listings | 12 |
| Devices | Electrosurgical, Cutting & Coagulation & Accessories; Intervertebral Body Graft Containment Device; Catheter, Percutaneous; Electrode, Depth; Dilator, Esophageal; Stents, Drains And Dilators For The Biliary Ducts; Device, Vascular, For Promoting Embolization; Negative Pressure Wound Therapy Powered Suction Pump |
| Product codes | GEI, OQB, DQY, GZL, KNQ, FGE, KRD, OMP |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery, Orthopedic, Cardiovascular, Neurology, Gastroenterology, Urology |
| Brand names | Olympus2295 (MN) - POWERSEAL OPEN EXTENDED JAW; Spineology5627 (MN) - OptiMesh HA Nano Multiplanar Expandable Interbody Fusion; AbbottStructural (MN) - Amplatzer TorqVue Exchange System; AbbottStructural (MN) - Amplatzer Valvular Plug III; AbbottStructural (MN) - Amplatzer Piccolo Delivery System; AbbottStructural (MN) - Amplatzer TorqVue Delivery System; AbbottStructural (MN) - Amplatzer TorqVue Intravascular Delivery System; AbbottStructural (MN) - Amplatzer TorqVue LP Catheter |
| First new listing | 2026-05-29 |
| Latest new listing | 2026-10-14 |
| FDA registration number | 2183744 |
| Registration expires | 2027-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

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: 2026-11-04T21:52:36.524Z.
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.