510(k) Report

FDA applicant

Svenska Medita Ac.

Hazlehurst, MS3 decisions1989–19890 recalls

FDA records 3 decisions for Svenska Medita Ac. (Hazlehurst, MS) in 1989: 3 510(k) clearances. Most are in product codes LYZ (Vinyl Patient Examination Glove) and LYY (Latex Patient Examination Glove). 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 Svenska Medita Ac.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Svenska Medita Ac. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Svenska”

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