Data / Medical devices / Keratome, Ac-Powered / United States
FDA-registered makers of Keratome, Ac-Powered in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Keratome, Ac-Powered (product code HNO). 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
- Keratome, Ac-Powered
- Product code
- HNO
- Country
- United States
Makers of Keratome, Ac-Powered in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Med-Logics, Inc. | Athens, TX, United States | Manufacturer | 9 | January 13, 2004 | 0 | 1 | 0 | api.fda.gov |
| Microspecialties LLC | Middletown, CT, United States | Manufacturer, Manufacturer for export | 5 | May 25, 2004 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Saint Louis, MO, United States | Remanufacturer | 2 | March 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| A7 Precision Machine Technology Inc. | Doral, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AMO Manufacturing USA, LLC | Milpitas, CA, United States | Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Alcon Research, LLC | Lake Forest, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Houston, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onyx Medical LLC | Memphis, TN, United States | Contract manufacturer | 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.