Data / Medical devices / United States / STERIMED, Inc.
STERIMED, Inc.: FDA-registered device maker in Ridgeville, SC, United States, 1 510(k) clearance
STERIMED, Inc. is registered with the FDA (registration 1053306) in Ridgeville, SC, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 16, 1993. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1053306
- Address
- 2266 Volvo Car Dr Suite 100, Ridgeville, SC, United States, 29472
- Owner or operator
- STERIMED, Inc. (9005559)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 27, 2007
- Registered through
- 2026
- Brand names listed
- Single Use Container Filter, Sterisheet
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Contract manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 16, 1993 | K931202 | STERILIZATION WRAP-STERISHEET | FRG | Substantially Equivalent | Arjo Wiggins Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wrap, Sterilization
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Updated December 16, 1993. 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.