510(k) Report

FDA applicant

Smith & Nephew, Mpl Division

Mchenry, IL9 decisions1976–19840 recalls

FDA records 9 decisions for Smith & Nephew, Mpl Division (Mchenry, IL) from 1976 to 1984: 9 510(k) clearances. Most are in product codes EJI (Syringe, Cartridge) and FMI (Needle, Hypodermic, Single Lumen). 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, dental panel, where it files most

How often FDA has decided Smith & Nephew, Mpl Division’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Smith & Nephew, Mpl Division since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Smith & Nephew, Mpl Division by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Smith”

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