510(k) Report

FDA applicant

Bemis Mfg. Co.

Sheboygan Falls, WI12 decisions1985–20022 recalls

FDA records 12 decisions for Bemis Mfg. Co. (Sheboygan Falls, WI) from 1985 to 2002: 12 510(k) clearances. Most are in product codes MMK (Container, Sharps) and FMI (Needle, Hypodermic, Single Lumen). 2 recalls are 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 Bemis Mfg. Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bemis Mfg. Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Bemis”

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