510(k) Report

FDA applicant

Markwell Medical Institute, Inc.

Mchenry, IL1 decision1983–19830 recalls

FDA records 1 decision for Markwell Medical Institute, Inc. (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code 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, general hospital panel, where it files most

How often FDA has decided Markwell Medical Institute, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Markwell Medical Institute, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Markwell”

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