FDA applicant

Oculo Plastik, Inc.

Montreal, Quebec Canada, CA13 decisions1990–20130 recalls

FDA records 13 decisions for Oculo Plastik, Inc. (Montreal, Quebec Canada, CA) from 1990 to 2013: 13 510(k) clearances. Most are in product codes HPZ (Implant, Eye Sphere) and HQX (Implant, Orbital, Extra-Ocular). Its devices cite 2 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Oculo-Plastik, Inc.”.

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 Oculo Plastik, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Oculo Plastik, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Oculo”

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

Oculo-Plastik Reg'D 1

Oculo Plastik, 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?

Other applicant names beginning “Oculo”