FDA applicant

Phakosystems, Inc.

Downsview M3j 2t9, CA5 decisions1983–19880 recalls

FDA records 5 decisions for Phakosystems, Inc. (Downsview M3j 2t9, CA) from 1983 to 1988: 5 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and HOC (Clip, Iris Retractor). 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 Phakosystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Phakosystems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Phakosystems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?