Data / Medical devices / Otoscope

Otoscope (ERA): 174 FDA-registered makers in 26 countries

174 establishments in 26 countries are registered with the FDA to make Otoscope (product code ERA, Class 1, 21 CFR 874.4770). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 56 510(k) clearances under this code, the latest on May 17, 2013, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code

ERA

Device class

1

Regulation

874.4770

Medical specialty

Ear, Nose, Throat

Makers by country

Makers of Otoscope

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 May 17, 2013. 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.