Data / Medical devices / Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) (HOY): 598 FDA-registered makers in 33 countries

598 establishments in 33 countries are registered with the FDA to make Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) (product code HOY, Class 1, 21 CFR 886.4750). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 55 510(k) clearances under this code, the latest on April 28, 2014, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code

HOY

Device class

1

Regulation

886.4750

Medical specialty

Ophthalmic

Makers by country

Makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated April 28, 2014. 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.