FDA applicant

Gerard Medical, Inc.

Charlton, MA4 decisions1994–19980 recalls

FDA records 4 decisions for Gerard Medical, Inc. (Charlton, MA) from 1994 to 1998: 4 510(k) clearances. Most are in product codes GDM (Needle, Aspiration And Injection, Reusable) and FTL (Mesh, Surgical, Polymeric). 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Gerard Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Gerard Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Gerard”

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

Gerard Medical Enterprises, Inc. 8

Gerard Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Gerard”