Data / Medical devices / Camera, Ophthalmic, Ac-Powered / United States
FDA-registered makers of Camera, Ophthalmic, Ac-Powered in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make Camera, Ophthalmic, Ac-Powered (product code HKI). 9 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
- Camera, Ophthalmic, Ac-Powered
- Product code
- HKI
- Country
- United States
Makers of Camera, Ophthalmic, Ac-Powered in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Nidek Incorporated | The Colony, TX, United States | Manufacturer | 4 | April 1, 2019 | 0 | 2 | 0 | api.fda.gov |
| Optovue, Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | July 3, 2013 | 0 | 1 | 0 | api.fda.gov |
| Phoenix Technology Group LLC | Pleasanton, CA, United States | Complaint file establishment, Manufacturer | 2 | September 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| TearScience, Inc. | Milpitas, CA, United States | Manufacturer, Specification developer | 2 | December 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Manufacturer | 2 | March 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Carl Zeiss Meditec Inc | Dublin, CA, United States | Contract manufacturer, Repackager or relabeler | 1 | June 8, 2018 | 0 | 0 | 0 | api.fda.gov |
| Fundus Photo | Saint Louis, MO, United States | Manufacturer | 1 | November 17, 2010 | 0 | 0 | 0 | api.fda.gov |
| Iscreen Vision Inc. | Cordova, TN, United States | Specification developer | 1 | January 12, 2011 | 0 | 0 | 0 | api.fda.gov |
| Optain Health | Akron, OH, United States | Complaint file establishment, Specification developer | 1 | April 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Imaging, Inc. | Goleta, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Products And Engineering | Milwaukee, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Optics Corp. | Gardner, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spartronics Strongsville, Inc. | Strongsville, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Topcon Healthcare, Inc. | Oakland, NJ, United States | Manufacturer, Manufacturer for export | 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.