FDA Device Intelligence
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Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

FDA product code HOY · Class 1 · Ophthalmic

670
Registered devices
49
Adverse events
1
Recalls
55
510(k) clearances

Devices with this code

Autoclavable Plastic Ocular Shield, bilateral, large, black, with handle — Oculo-Plastik IncAutoclavable Plastic Ocular Shield, bilateral, large, black — Oculo-Plastik IncOCULAR SHIELD — FCI S A S FCI 20 22MSI Precision Specialty Instruments — Med Saver, Inc.maxill Frames Eyewear Adult — MAXILL, INC.EMSRUN — Wuxi Emsrun Technology Co., Ltd.Ease-In-Shields — ULTRADENT PRODUCTS, INC.Cox® II, SS Ocular Laser Shield, small (non glare) w. suction cup — Oculo-Plastik IncOZARK TRAIL — Eye Ojo Corp.VIVIT Supply — Vivit Supply LLCCox® II, SS Ocular Laser Shield, left, medium (non glare) w. handle, refurb. — Oculo-Plastik IncClear Choice — Southmedic IncorporatedUVEX BLACK CLEAR LENS — HAGER WORLDWIDE, INC.MSI Precision Specialty Instruments — Med Saver, Inc.Clear Choice — Southmedic IncorporatedMSI Precision Specialty Instruments — Med Saver, Inc.Clear Choice — Southmedic IncorporatedEase-In-Shields — ULTRADENT PRODUCTS, INC.UVEX GENESIS MMT - 50% Tint — HAGER WORLDWIDE, INC.Millennium — Avalign Technologies, Inc.Plasdent — PLASDENT CORPORATIONMSI Precision Specialty Instruments — Med Saver, Inc.DIA-100FS — DiaDent Group InternationalAutoclavable Plastic Ocular Shield, bilateral, small, black — Oculo-Plastik Inc

Recent recalls

DateFirmReason
2008-06-05Phillips Safety ProductsRadiation Protective Eyewear does not meet the radiation protection levels stated on the labeling.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.