Data / Medical devices / Sterilizer, Ethylene-Oxide Gas / United States
FDA-registered makers of Sterilizer, Ethylene-Oxide Gas in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Sterilizer, Ethylene-Oxide Gas (product code FLF). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Sterilizer, Ethylene-Oxide Gas
- Product code
- FLF
- Country
- United States
Makers of Sterilizer, Ethylene-Oxide Gas in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Andersen Sterilizers, Inc. | Haw River, NC, United States | Manufacturer | 3 | November 12, 2020 | 0 | 0 | 0 | api.fda.gov |
| Advanced Sterilization Products | Irvine, CA, United States | Manufacturer | 1 | April 3, 2003 | 0 | 3 | 0 | api.fda.gov |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 1 | January 8, 2015 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 1 | January 8, 2015 | 0 | 0 | 0 | api.fda.gov |
| ARC Specialty Products, Balchem Corporation | Green Pond, SC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. | Auburn Hills, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.