510(k) Report

FDA applicant

Malibu Laboratories

Mchenry, IL3 decisions1979–19800 recalls

FDA records 3 decisions for Malibu Laboratories (Mchenry, IL) from 1979 to 1980: 3 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). 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 and plastic surgery panel, where it files most

How often FDA has decided Malibu Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Malibu Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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