FDA applicant

Mentor O & O, Inc.

Norwell, MA18 decisions1982–19965 recalls

FDA records 18 decisions for Mentor O & O, Inc. (Norwell, MA) from 1982 to 1996: 18 510(k) clearances. Most are in product codes HOX (Chart, Visual Acuity) and HQE (Instrument, Vitreous Aspiration And Cutting…). 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Mentor O & O, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mentor O & O, Inc. since 2007.

Recalls per year

2in 2022

2007high 2 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Mentor O & O, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Mentor”

FDA records each applicant name separately; these may or may not be the same firm.

Mentor Corp. 67 Mentor Worldwide, LLC 14 Mentor Ophthalmics, Inc. 4 Mentor Medical Limited 1 Mentor Urology, Inc. 1

Mentor O & O, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Mentor”