FDA applicant

Massachusetts Eye and Ear Infirmary D/B/A Boston

Boston, MA1 decision2019–20190 recalls

FDA records 1 decision for Massachusetts Eye and Ear Infirmary D/B/A Boston (Boston, MA) in 2019: 1 510(k) clearance. All are in product code HQM (Keratoprosthesis, Permanent Implant). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is 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 Massachusetts Eye and Ear Infirmary D/B/A Boston’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Massachusetts Eye and Ear Infirmary D/B/A Boston by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Massachusetts”

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

Massachusetts General Hospital 1 Massachusetts Eye & Ear Infirmary 1

Massachusetts Eye and Ear Infirmary D/B/A Boston

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Massachusetts”