FDA applicant

Mdt Biologic Co.

Rochester, NY8 decisions1991–19960 recalls

FDA records 8 decisions for Mdt Biologic Co. (Rochester, NY) from 1991 to 1996: 8 510(k) clearances. Most are in product codes FLE (Sterilizer, Steam) and FLF (Sterilizer, Ethylene-Oxide Gas). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Mdt Biologic Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mdt Biologic Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Mdt Biologic Co.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?