Data / Medical devices / Device, Irrigation, Ocular Surgery / United States
FDA-registered makers of Device, Irrigation, Ocular Surgery in the United States: 30 establishments
30 establishments in the United States are registered with the FDA to make Device, Irrigation, Ocular Surgery (product code KYG). 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
- Device, Irrigation, Ocular Surgery
- Product code
- KYG
- Country
- United States
Makers of Device, Irrigation, Ocular Surgery in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Iridex Corporation | San Jose, CA, United States | Manufacturer | 1 | February 19, 1998 | 0 | 0 | 0 | api.fda.gov |
| Iridex Corporation | Mountain View, CA, United States | Manufacturer | 1 | February 19, 1998 | 0 | 0 | 0 | api.fda.gov |
| Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 1 | May 19, 1998 | 0 | 0 | 0 | api.fda.gov |
| 0625, LLC | Gibsonia, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anodyne Surgical | O Fallon, MO, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Lake Forest, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Houston, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Manchester, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Saint Louis, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beaver-Visitec International, Inc. | Waltham, MA, United States | Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Carwild Corp. | New London, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eagle Labs, LLC | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Esi, Inc. | Minneapolis, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katena Products, Inc. | Parsippany, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katena Products, Inc. | Randolph, NJ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med-Logics, Inc. | Athens, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meddux Development Corporation LLC | Boulder, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Techniques, Inc. | North Salt Lake, UT, United States | Complaint file establishment, Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microsurgical Technology, Inc. | Redmond, WA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peregrine Surgical, LLC. | New Britain, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| QTD Plastics | Meadville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Raico | Westmont, IL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saint-Gobain Performance Plastics | Portage, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volk Optical Inc. | Mentor, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zevex, Inc. | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zien Medical Technologies LLC | Salt Lake City, UT, 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.