FDA applicant

Mathys Corp.

Malvern, PA2 decisions1991–20100 recalls

FDA records 2 decisions for Mathys Corp. (Malvern, PA) from 1991 to 2010: 2 510(k) clearances. All are in product code LYC (Bone Grafting Material, Synthetic). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Mathys, Ltd.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Mathys Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Mathys”

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

Mathys Corp. of North America 1

Mathys Corp.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Mathys”