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Data / Medical devices / Grid, Amsler

Grid, Amsler (HOQ): 8 FDA-registered makers in 5 countries

8 establishments in 5 countries are registered with the FDA to make Grid, Amsler (product code HOQ, Class 1, 21 CFR 886.1330). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on June 27, 2018, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
HOQ
Device class
1
Regulation
886.1330
Medical specialty
Ophthalmic

Makers by country

CountryMakers
United States4
Switzerland1
India1
Japan1
United Kingdom1

Makers of Grid, Amsler

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Oculocare Medical AGZurich, SwitzerlandManufacturer1June 27, 2018000api.fda.gov
Akriti Ophthalmic Private LimitedHyderabad Telangana, IndiaManufacturer0000api.fda.gov
Eyeque CorporationNewark, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Gulden OphthalmicsElkins Park, PA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Inami & Co., Ltd.Bunkyo Tokyo, JapanManufacturer0000api.fda.gov
Keeler Ltd.WINDSOR, BERKSHIRE Windsor and Maidenhead, United KingdomSpecification developer0000api.fda.gov
KYS Vision, Inc.Elko, NV, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Vision Training Products, Inc.Mishawaka, IN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov

Updated June 27, 2018. 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.