510(k) Report

FDA applicant

Pharma-Plast USA, Inc.

Canada H3a 2n4, CA9 decisions1985–19890 recalls

FDA records 9 decisions for Pharma-Plast USA, Inc. (Canada H3a 2n4, CA) from 1985 to 1989: 9 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FMF (Syringe, Piston). 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, general hospital panel, where it files most

How often FDA has decided Pharma-Plast USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pharma-Plast USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pharma-Plast USA, 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