Data / Medical devices / Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) / United States
FDA-registered makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) in the United States: 90 establishments
90 establishments in the United States are registered with the FDA to make Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) (product code HOY). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- Product code
- HOY
- Country
- United States
Makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Manufacturer, Specification developer | 2 | October 2, 1991 | 0 | 0 | 0 | api.fda.gov |
| Alphaprotech, Inc. | Nogales, AZ, United States | Specification developer | 1 | March 21, 1988 | 0 | 0 | 0 | api.fda.gov |
| Katena Products, Inc. | Parsippany, NJ, United States | Specification developer | 1 | January 31, 1992 | 0 | 0 | 0 | api.fda.gov |
| Katena Products, Inc. | Randolph, NJ, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | January 31, 1992 | 0 | 0 | 0 | api.fda.gov |
| Alira Medical Devices LLC | Rancho Cucamonga, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alpha Omega Polymer Technologies Inc. | Kennedale, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ama Optics, Inc. | Miami Beach, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amitofo Inc. | Denver, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asia Pacific Trading Co., Inc. | Vernon, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atlanta Healthcare Services | Lawrenceville, GA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aurora Surgical, LLC | St Petersburg, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Fort Worth, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apyx Medical Corporation | Clearwater, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avedro, A Glaukos Company | Burlington, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benicci Inc | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 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 | |
| Beaver-Visitec International, Inc. | Waltham, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Care Surgical LLC | Hudson, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carwild Corp. | New London, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cole Instruments | Alpharetta, GA, United States | Complaint file establishment, Remanufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordica Medical, Inc. | Haverhill, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cynosure, LLC | Westford, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Den-Mat Holdings, LLC | Lompoc, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Maynardville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DOMA Patient Safety Products, LLC | Santa Paula, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dupaco, Inc. | Oceanside, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dynamic Diagnostics Incorporated | Plymouth, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DeRoyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Devoted Creations, Inc. | Oldsmar, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eason Eyewear Inc. | Hempstead, NY, United States | Remanufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Encore Vision Inc | Spokane, WA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eye Shield Technology, Inc. | Houston, TX, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabriteq | Knoxville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresnel Prism & Lens Co. | Bloomington, MN, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fischer Surgical Inc. | Imperial, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G & G Products, LLC | Kennebunk, ME, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| GF Health Products, Inc | Atlanta, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gfa Production Inc | Clearwater, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gulden Ophthalmics | Elkins Park, PA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Head Usa, Inc. | Boulder, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi-Tech Products Inc. | Buena Park, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hurricane Medical | Bradenton, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intec Industries, Inc. | Birmingham, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovize | North Oaks, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumed International Inc dba Avalign German Specialty Instruments | Schaumburg, IL, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jardon Eye Prosthetics, Inc. | Southfield, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KBD, Inc. | North Las Vegas, NV, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kelcor, LLC | Chattanooga, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Knockaround, LLC | Chula Vista, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kwik Tek, Inc. | Denver, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lidlift, LLC | West Valley City, UT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LT Acquisition, Inc. | Caledonia, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med-Linket Corp | Alhambra, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Concepts | Temecula, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Morrison Corporation | Glens Falls, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medegen Medical Products | Gallaway, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Newtrans International Company | Nashville, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nictavi | Los Angeles, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nomax, Inc. | Affton, MO, United States | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NoIR | Milford, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Obbomed Group LLC | Pomona, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onlycare Inc | Denver, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optego Vision USA, Inc. | Tucson, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PDS Optical | Louisville, KY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PDS Optical Florida | Fort Lauderdale, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phillips Safety Products, Inc. | Middlesex, NJ, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Physician Recommended Nutriceuticals PRN | Blue Bell, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polymer Science, Inc. | Monticello, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prairie Products, Inc. | Dover, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prestige Ameritech | North Richland Hills, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Optics LLC | Palatine, IL, 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 | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sciton, Inc. | Palo Alto, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Southwest Quality Molding | Manvel, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Orthodontics Corporation | Monrovia, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterling Medical Products | Prophetstown, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theia Medical | Cumberland, RI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trademark Plastics Inc. | Riverside, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ultradent Products Inc. | South Jordan, UT, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vision Training Products, Inc. | Mishawaka, IN, United States | Repackager or relabeler, Specification developer | 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.