Data / Medical devices / Shield, Eye, Radiological / United States
FDA-registered makers of Shield, Eye, Radiological in the United States: 16 establishments
16 establishments in the United States are registered with the FDA to make Shield, Eye, Radiological (product code IWS). 1 has a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Shield, Eye, Radiological
- Product code
- IWS
- Country
- United States
Makers of Shield, Eye, Radiological in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Best Medical International, Inc. | Springfield, VA, United States | Manufacturer | 1 | December 30, 1994 | 0 | 0 | 0 | api.fda.gov |
| Aadco Medical, Inc. | Randolph, VT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Barrier Technologies, LLC | Davie, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Burlington Medical, LLC | Newport News, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Burlington Medical LLC | Newport News, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dupaco, Inc. | Oceanside, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infab, LLC. | Camarillo, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| LT Acquisition, Inc. | Caledonia, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lucas Specialty Products | Toledo, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Oral Healthcare, LLC | Bothell, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phillips Safety Products, Inc. | Middlesex, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Protech Leaded Eyewear, Inc. | West Palm Beach, FL, United States | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiation Products Design, Inc. | Albertville, MN, United States | Manufacturer, Repackager or relabeler | 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.