FDA applicant

Ocular Therapeutix, Inc.

Bedford, MA2 decisions2013–20140 recalls

FDA records 2 decisions for Ocular Therapeutix, Inc. (Bedford, MA) from 2013 to 2014: 1 510(k) clearance and 1 original PMA approval. Most are in product codes HKY (Tonometer, Manual) and PFZ (Ophthalmic Sealant). 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 Ocular Therapeutix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Ocular Therapeutix, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Ocular”

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

Ocular Instruments, Inc. 50 Ocular Sciences Puerto Rico, Inc. 7 Ocular Sciences 2 Ocular Innovations, Inc. 2 Ocular Blood Flow Laboratories, Inc. 2 Ocular Concepts, LLC 1 Ocular Pharmaceuticals, Inc. 1 Ocular Systems, Inc. 1

Ocular Therapeutix, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ocular”