510(k) Report

FDA applicant

Fatswith Intl., Inc.

Vancouver, Bc,, CA1 decision1996–19960 recalls

FDA records 1 decision for Fatswith Intl., Inc. (Vancouver, Bc,, CA) in 1996: 1 510(k) clearance. All are in product code HPM (Locator, Metal, Electronic). 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 Fatswith Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fatswith Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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