Data / Medical devices / Tonometer, Manual / United States
FDA-registered makers of Tonometer, Manual in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Tonometer, Manual (product code HKY). 8 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Tonometer, Manual
- Product code
- HKY
- Country
- United States
Makers of Tonometer, Manual in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Accutome, Inc. | Malvern, PA, United States | Complaint file establishment, Manufacturer | 5 | December 31, 2015 | 0 | 0 | 0 | api.fda.gov |
| Reichert Inc. | Depew, NY, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 5 | May 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Zien Medical Technologies LLC | Salt Lake City, UT, United States | Manufacturer, Specification developer | 3 | February 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Katena Products, Inc. | Randolph, NJ, United States | Repackager or relabeler, Specification developer | 2 | October 13, 2015 | 0 | 0 | 0 | api.fda.gov |
| Automated Ophthalmics Inc | Elkridge, MD, United States | Manufacturer | 1 | January 10, 2000 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Manchester, MO, United States | Manufacturer | 1 | July 2, 2001 | 0 | 0 | 0 | api.fda.gov |
| Falck Medical Corporation | Mystic, CT, United States | Manufacturer | 1 | June 3, 2008 | 0 | 0 | 0 | api.fda.gov |
| Katena Products, Inc. | Parsippany, NJ, United States | Specification developer | 1 | October 13, 2015 | 0 | 0 | 0 | api.fda.gov |
| Atc Technologies Inc. | Wilmington, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Friendship Industries | Harrisonburg, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kiltex Corp. | Akron, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ocular Instruments, Inc. | Bellevue, WA, United States | 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.