FDA applicant

Bioderm Sciences, Inc.

Gaithersburg, MD3 decisions2004–20050 recalls

FDA records 3 decisions for Bioderm Sciences, Inc. (Gaithersburg, MD) from 2004 to 2005: 3 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 10 predicates, 3 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

How often FDA has decided Bioderm Sciences, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bioderm Sciences, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bioderm Sciences, Inc.’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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Other applicant names beginning “Bioderm”

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

Bioderm, Inc. 14

Bioderm Sciences, Inc.

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?

Other applicant names beginning “Bioderm”