Data / Medical devices / United States / Steri-Shield Incorporated
Steri-Shield Incorporated: FDA-registered device maker in Fernandina Beach, FL, United States, 1 510(k) clearance
Steri-Shield Incorporated is registered with the FDA (registration 3011326671) in Fernandina Beach, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 17, 1989. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011326671
- Address
- 1417 Sadler Rd #259, Fernandina Beach, FL, United States, 32034
- Owner or operator
- Steri-Shield Incorporated (10048330)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 30, 2014
- Registered through
- 2026
- Brand names listed
- Bracket Label Arm Cover, X-ray Film Holder
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Holder, Film, X-Ray | EGZ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 17, 1989 | K884219 | BRACKET TABLE ARM COVER | EIA | Substantially Equivalent | Steri-Shield Products, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 17, 1989. 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.