510(k) Report

FDA applicant

Loseff Medical Designers, Ltd.

Mchenry, IL2 decisions1980–19800 recalls

FDA records 2 decisions for Loseff Medical Designers, Ltd. (Mchenry, IL) in 1980: 2 510(k) clearances. Most are in product codes GBA (Catheter, Balloon Type) and JCX (Apparatus, Suction, Ward Use, Portable…). 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 Loseff Medical Designers, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Loseff Medical Designers, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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