510(k) Report

FDA applicant

Medical Armor Corp.

Fremont, MD5 decisions1988–19930 recalls

FDA records 5 decisions for Medical Armor Corp. (Fremont, MD) from 1988 to 1993: 5 510(k) clearances. All are in product code LYU (Accessory, Surgical Apparel). 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 Medical Armor Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Armor Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Armor Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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