Data / Medical devices / Ophthalmoscope, Ac-Powered / United States
FDA-registered makers of Ophthalmoscope, Ac-Powered in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Ophthalmoscope, Ac-Powered (product code HLI). 6 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Ophthalmoscope, Ac-Powered
- Product code
- HLI
- Country
- United States
Makers of Ophthalmoscope, Ac-Powered in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Optovue, Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 6 | February 11, 2016 | 0 | 3 | 0 | api.fda.gov |
| Carl Zeiss Meditec Inc | Dublin, CA, United States | Manufacturer | 4 | January 26, 2007 | 0 | 1 | 0 | api.fda.gov |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Manufacturer, Specification developer | 4 | January 25, 2001 | 0 | 0 | 0 | api.fda.gov |
| Hai Laboratories, Inc. | Lexington, MA, United States | Manufacturer | 1 | September 20, 2000 | 0 | 0 | 0 | api.fda.gov |
| Optos Inc. | Southborough, MA, United States | Manufacturer | 1 | February 3, 1999 | 0 | 0 | 0 | api.fda.gov |
| R & D Batteries, Inc. | Burnsville, MN, United States | Manufacturer | 1 | February 22, 1994 | 0 | 0 | 0 | api.fda.gov |
| Ray Vision Inc. | Lake Forest, CA, United States | Repackager or relabeler, Specification developer | 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.