FDA applicant

Lehigh Group

Concord, MA1 decision1986–19860 recalls

FDA records 1 decision for Lehigh Group (Concord, MA) in 1986: 1 510(k) clearance. All are in product code LKY (Device, External Penile Rigidity). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Lehigh Group since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Lehigh”

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

Lehigh Consolidated Industries 1

Lehigh Group

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Lehigh”