Data / Medical devices / Biomicroscope, Slit-Lamp, Ac-Powered / United States
FDA-registered makers of Biomicroscope, Slit-Lamp, Ac-Powered in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Biomicroscope, Slit-Lamp, Ac-Powered (product code HJO). 3 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Biomicroscope, Slit-Lamp, Ac-Powered
- Product code
- HJO
- Country
- United States
Makers of Biomicroscope, Slit-Lamp, Ac-Powered in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Reichert Inc. | Depew, NY, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 4 | October 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| Hai Laboratories, Inc. | Lexington, MA, United States | Manufacturer, Repackager or relabeler | 1 | December 4, 2003 | 0 | 0 | 0 | api.fda.gov |
| Nidek Incorporated | The Colony, TX, United States | Manufacturer | 1 | June 11, 2014 | 0 | 1 | 0 | api.fda.gov |
| Carl Zeiss Meditec Inc | Dublin, CA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Karl Storz Imaging, Inc. | Goleta, CA, 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 | |
| TearScience, Inc. | Milpitas, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Topcon Healthcare, Inc. | Oakland, NJ, United States | Manufacturer for export | 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.