# Isomedix Operations, Inc. (contract sterilizer, Minneapolis, MN): 16 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 | 16 |
| Devices | Electrosurgical, Cutting & Coagulation & Accessories; Device, Vascular, For Promoting Embolization; Catheter, Percutaneous; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System; Syringe, Antistick; Needle, Hypodermic, Single Lumen; Syringe, Piston; Electrode, Depth; Intervertebral Body Graft Containment Device; Negative Pressure Wound Therapy Powered Suction Pump |
| Product codes | GEI, KRD, DQY, ONB, MEG, FMI, FMF, GZL, OQB, OMP, KNQ, FGE |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery, Cardiovascular, General Hospital, Neurology, Orthopedic, Gastroenterology, Urology |
| Brand names | Olympus2295 (MN) - POWERSEAL OPEN EXTENDED JAW; AbbottStructural (MN) - Amplatzer Valvular Plug III; AbbottStructural (MN) - Amplatzer TorqVue Exchange System; Spineology5627 (MN) - OptiMesh HA Nano Multiplanar Expandable Interbody Fusion; AbbottStructural (MN) - Amplatzer TorqVue LP Catheter; AbbottStructural (MN) - Amplatzer TorqVue LP Delivery System; AbbottStructural (MN) - Amplatzer Piccolo Delivery System; AbbottStructural (MN) - Amplatzer TorqVue Delivery System |
| First new listing | 2026-05-29 |
| Latest new listing | 2026-10-21 |
| 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.