FDA applicant

Lukens Medical Corp.

Mahwah, NJ8 decisions1991–19971 recall

FDA records 8 decisions for Lukens Medical Corp. (Mahwah, NJ) from 1991 to 1997: 8 510(k) clearances. Most are in product codes GAT (Suture, Nonabsorbable, Synthetic, Polyethylene) and GAQ (Suture, Nonabsorbable, Steel, Monofilament And…). 1 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 Lukens Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lukens Medical Corp. since 2007.

Recalls per year

1in 2024

2007high 1 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Lukens Medical 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 “Lukens”

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

Lukens Corp. 11

Lukens Medical Corp.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Lukens”