Data / Medical devices / Screen, Leaded, Operator Radiation Protector
Screen, Leaded, Operator Radiation Protector (EAK): 21 FDA-registered makers in 6 countries
21 establishments in 6 countries are registered with the FDA to make Screen, Leaded, Operator Radiation Protector (product code EAK, Class 1, 21 CFR 892.6500). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on June 16, 1995, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- EAK
- Device class
- 1
- Regulation
- 892.6500
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 15 |
| China | 2 |
| United Kingdom | 1 |
| Germany | 1 |
| South Korea | 1 |
| Canada | 1 |
Makers of Screen, Leaded, Operator Radiation Protector
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aadco Medical, Inc. | Randolph, VT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alimed, LLC | Dedham, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Burlington Medical, LLC | Newport News, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Del Medical, Inc. | Bloomingdale, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ecls | Saint Louis, MO, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Egg Medical, Inc. | Roseville, MN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FT Industries, Inc | Bessemer, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Image Diagnostics, Inc. | Fitchburg, MA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infab, LLC. | Camarillo, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd | Danyang Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kenex (electro-Medical) Ltd. | HARLOW Essex, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mavig GMBH | MUNICH Bavaria, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Msline Eng Co Ltd | Icheon-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phillips Safety Products, Inc. | Middlesex, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RAMPART IC, Inc | Birmingham, AL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RAMPART IC, Inc | Vestavia, AL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Salus Scientific Corp | Charleston, SC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Techno-Aide, Inc. | Whites Creek, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ultraray Group Inc. | Oakville Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhengzhou Henghao Optical Technology Co. Ltd. | Zhengzhou Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| trans radial solutions | Roebuck, SC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 16, 1995. 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.