Data / Medical devices / Pad, Neonatal Eye

Pad, Neonatal Eye (FOK): 23 FDA-registered makers in 7 countries

23 establishments in 7 countries are registered with the FDA to make Pad, Neonatal Eye (product code FOK, Class 1, 21 CFR 880.5270). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on July 3, 1996, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

FOK

Device class

1

Regulation

880.5270

Medical specialty

General Hospital

Makers by country

Makers of Pad, Neonatal Eye

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 July 3, 1996. 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.