Data / Medical devices / Sterilizer, Steam / United States
FDA-registered makers of Sterilizer, Steam in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make Sterilizer, Steam (product code FLE). 11 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Sterilizer, Steam
- Product code
- FLE
- Country
- United States
Makers of Sterilizer, Steam in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Tuttnauer Usa Co. Ltd. | Hauppauge, NY, United States | Manufacturer | 10 | November 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Primus Sterilizer Company, LLC. | Great Bend, KS, United States | Manufacturer | 5 | December 19, 2023 | 0 | 0 | 0 | api.fda.gov |
| PRIMUS Sterilizer Company LLC | Sanford, FL, United States | Manufacturer | 5 | December 19, 2023 | 0 | 0 | 0 | api.fda.gov |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 5 | July 25, 2002 | 0 | 0 | 0 | api.fda.gov |
| Fort Defiance Industries LLC | Loudon, TN, United States | Complaint file establishment, Manufacturer | 2 | March 2, 2022 | 0 | 3 | 0 | api.fda.gov |
| Midmark Corporation | Versailles, OH, United States | Manufacturer | 2 | April 4, 2024 | 0 | 2 | 0 | api.fda.gov |
| Revolutionary Science | Shafer, MN, United States | Manufacturer | 2 | May 23, 2013 | 0 | 0 | 0 | api.fda.gov |
| Aesculap, Inc. | Center Valley, PA, United States | Complaint file establishment, Specification developer | 1 | December 27, 1979 | 0 | 0 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 1 | December 27, 1979 | 0 | 0 | 0 | api.fda.gov |
| Consolidated Machine Corp. | Billerica, MA, United States | Complaint file establishment, Manufacturer | 1 | August 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Lucas Lifecare, LLC | Janesville, WI, United States | Manufacturer | 1 | December 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wisconsin Aluminum Foundry Co., Inc. | Manitowoc, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.