Data / Medical devices / Sterilant, Medical Devices / United States
FDA-registered makers of Sterilant, Medical Devices in the United States: 19 establishments
19 establishments in the United States are registered with the FDA to make Sterilant, Medical Devices (product code MED). 16 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 3, 2026.
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- Device
- Sterilant, Medical Devices
- Product code
- MED
- Country
- United States
Makers of Sterilant, Medical Devices in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Steris Corporation | Mentor, OH, United States | Specification developer | 19 | April 8, 2026 | 0 | 8 | 0 | api.fda.gov |
| STERIS Corporation | Mentor, OH, United States | Manufacturer | 19 | April 8, 2026 | 0 | 3 | 0 | api.fda.gov |
| STERIS Corporation | Mentor, OH, United States | Manufacturer | 19 | April 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Metrex Research | Romulus, MI, United States | Manufacturer | 5 | August 19, 2014 | 0 | 0 | 0 | api.fda.gov |
| Advanced Sterilization Products | Irvine, CA, United States | Complaint file establishment, Specification developer | 2 | April 4, 2005 | 0 | 4 | 0 | api.fda.gov |
| Medivators Inc | Minneapolis, MN, United States | Manufacturer | 2 | September 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Steris Corporation | Saint Louis, MO, United States | Manufacturer | 2 | April 12, 2010 | 0 | 0 | 0 | api.fda.gov |
| Alden Medical LLC | W Springfield, MA, United States | Contract manufacturer, Manufacturer | 1 | January 30, 2012 | 0 | 0 | 0 | api.fda.gov |
| Best Sanitizers, Inc. | Walton, KY, United States | Manufacturer | 1 | February 5, 2010 | 0 | 1 | 0 | api.fda.gov |
| Cetylite Industries, Inc. | Pennsauken, NJ, United States | Complaint file establishment, Manufacturer | 1 | September 10, 1998 | 0 | 0 | 0 | api.fda.gov |
| Dentsply LLC | York, PA, United States | Specification developer | 1 | March 30, 1999 | 0 | 0 | 0 | api.fda.gov |
| Medical Chemical Corporation | Torrance, CA, United States | Contract manufacturer, Manufacturer | 1 | August 10, 1995 | 0 | 0 | 0 | api.fda.gov |
| MicroCare Medical | Commerce City, CO, United States | Manufacturer | 1 | May 18, 1998 | 0 | 0 | 0 | api.fda.gov |
| Pascal International, Inc. | Bellevue, WA, United States | Manufacturer | 1 | May 27, 2003 | 0 | 1 | 0 | api.fda.gov |
| Serim Research Corp. | Elkhart, IN, United States | Manufacturer | 1 | March 26, 1992 | 0 | 0 | 0 | api.fda.gov |
| Weiman Products, LLC | Gurnee, IL, United States | Contract manufacturer, Manufacturer | 1 | September 2, 1998 | 0 | 0 | 0 | api.fda.gov |
| Accupac, LLC | Lakewood, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CS Medical LLC | Creedmoor, NC, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | Milford, DE, 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.