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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aspen Surgical Products, Inc.Caledonia, MI, United StatesManufacturer, Specification developer2October 2, 1991000api.fda.gov
Alphaprotech, Inc.Nogales, AZ, United StatesSpecification developer1March 21, 1988000api.fda.gov
Katena Products, Inc.Parsippany, NJ, United StatesSpecification developer1January 31, 1992000api.fda.gov
Katena Products, Inc.Randolph, NJ, United StatesManufacturer, Repackager or relabeler, Specification developer1January 31, 1992000api.fda.gov
Alira Medical Devices LLCRancho Cucamonga, CA, United StatesSpecification developer0000api.fda.gov
Alpha Omega Polymer Technologies Inc.Kennedale, TX, United StatesContract manufacturer0000api.fda.gov
Ama Optics, Inc.Miami Beach, FL, United StatesManufacturer0000api.fda.gov
Amitofo Inc.Denver, CO, United StatesManufacturer0000api.fda.gov
Asia Pacific Trading Co., Inc.Vernon, CA, United StatesSpecification developer0000api.fda.gov
Atlanta Healthcare ServicesLawrenceville, GA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Aurora Surgical, LLCSt Petersburg, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Alcon Research, LLCFort Worth, TX, United StatesSpecification developer0000api.fda.gov
Apyx Medical CorporationClearwater, FL, United StatesContract manufacturer0000api.fda.gov
Avedro, A Glaukos CompanyBurlington, MA, United StatesManufacturer for export0000api.fda.gov
Benicci IncMiami, FL, United StatesSpecification developer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Beaver-Visitec International, Inc.Waltham, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Care Surgical LLCHudson, MA, United StatesManufacturer0000api.fda.gov
Carwild Corp.New London, CT, United StatesContract manufacturer0000api.fda.gov
Cole InstrumentsAlpharetta, GA, United StatesComplaint file establishment, Remanufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Cordica Medical, Inc.Haverhill, MA, United StatesContract manufacturer0000api.fda.gov
Cynosure, LLCWestford, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Deroyal Industries, Inc.Maynardville, TN, United StatesContract manufacturer0000api.fda.gov
DOMA Patient Safety Products, LLCSanta Paula, CA, United StatesSpecification developer0000api.fda.gov
Dupaco, Inc.Oceanside, CA, United StatesManufacturer0000api.fda.gov
Dynamic Diagnostics IncorporatedPlymouth, MI, United StatesManufacturer0000api.fda.gov
DeRoyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Devoted Creations, Inc.Oldsmar, FL, United StatesManufacturer0000api.fda.gov
Eason Eyewear Inc.Hempstead, NY, United StatesRemanufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Encore Vision IncSpokane, WA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Eye Shield Technology, Inc.Houston, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
FabriteqKnoxville, TN, United StatesContract manufacturer0000api.fda.gov
Fresnel Prism & Lens Co.Bloomington, MN, United StatesManufacturer, Specification developer0000api.fda.gov
Fischer Surgical Inc.Imperial, MO, United StatesManufacturer0000api.fda.gov
G & G Products, LLCKennebunk, ME, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
GF Health Products, IncAtlanta, GA, United StatesSpecification developer0000api.fda.gov
Gfa Production IncClearwater, FL, United StatesSpecification developer0000api.fda.gov
Gulden OphthalmicsElkins Park, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Head Usa, Inc.Boulder, CO, United StatesSpecification developer0000api.fda.gov
Hi-Tech Products Inc.Buena Park, CA, United StatesContract manufacturer0000api.fda.gov
Hurricane MedicalBradenton, FL, United StatesManufacturer0000api.fda.gov
Intec Industries, Inc.Birmingham, AL, United StatesContract manufacturer0000api.fda.gov
InnovizeNorth Oaks, MN, United StatesContract manufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Jardon Eye Prosthetics, Inc.Southfield, MI, United StatesManufacturer0000api.fda.gov
KBD, Inc.North Las Vegas, NV, United StatesSpecification developer0000api.fda.gov
Kelcor, LLCChattanooga, TN, United StatesSpecification developer0000api.fda.gov
Knockaround, LLCChula Vista, CA, United StatesSpecification developer0000api.fda.gov
Kwik Tek, Inc.Denver, CO, United StatesContract manufacturer0000api.fda.gov
Lidlift, LLCWest Valley City, UT, United StatesSpecification developer0000api.fda.gov
LT Acquisition, Inc.Caledonia, MI, United StatesManufacturer0000api.fda.gov
Med-Linket CorpAlhambra, CA, United StatesManufacturer0000api.fda.gov
Medical ConceptsTemecula, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Morrison CorporationGlens Falls, NY, United StatesSpecification developer0000api.fda.gov
Medegen Medical ProductsGallaway, TN, United StatesSpecification developer0000api.fda.gov
Newtrans International CompanyNashville, TN, United StatesSpecification developer0000api.fda.gov
NictaviLos Angeles, CA, United StatesSpecification developer0000api.fda.gov
Nomax, Inc.Affton, MO, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
NoIRMilford, MI, United StatesSpecification developer0000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Obbomed Group LLCPomona, CA, United StatesSpecification developer0000api.fda.gov
Onlycare IncDenver, CO, United StatesManufacturer0000api.fda.gov
Optego Vision USA, Inc.Tucson, AZ, United StatesManufacturer0000api.fda.gov
PDS OpticalLouisville, KY, United StatesManufacturer0000api.fda.gov
PDS Optical FloridaFort Lauderdale, FL, United StatesManufacturer0000api.fda.gov
Phillips Safety Products, Inc.Middlesex, NJ, United StatesManufacturer0010api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Physician Recommended Nutriceuticals PRNBlue Bell, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Polymer Science, Inc.Monticello, IN, United StatesContract manufacturer0000api.fda.gov
Prairie Products, Inc.Dover, PA, United StatesManufacturer0000api.fda.gov
Prestige AmeritechNorth Richland Hills, TX, United StatesManufacturer0000api.fda.gov
Pro-Optics LLCPalatine, IL, United StatesManufacturer0000api.fda.gov
QTD PlasticsMeadville, PA, United StatesContract manufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Sciton, Inc.Palo Alto, CA, United StatesManufacturer0000api.fda.gov
Southwest Quality MoldingManvel, TX, United StatesManufacturer0000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sterling Medical ProductsProphetstown, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Theia MedicalCumberland, RI, United StatesManufacturer0000api.fda.gov
Trademark Plastics Inc.Riverside, CA, United StatesSpecification developer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Vision Training Products, Inc.Mishawaka, IN, United StatesRepackager or relabeler, Specification developer0000api.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.