FDA applicant

Gerard Medical Enterprises, Inc.

Charlton, MA8 decisions1981–199613 recalls

FDA records 8 decisions for Gerard Medical Enterprises, Inc. (Charlton, MA) from 1981 to 1996: 8 510(k) clearances. Most are in product codes LJT (Port & Catheter, Implanted, Subcutaneous…) and FMF (Syringe, Piston). 13 recalls are 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 hospital panel, where it files most

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

FDA decisions per year

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

Recalls per year

7in 2010

2007high 7 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Gerard Medical Enterprises, 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, Inc. 4

Gerard Medical Enterprises, Inc.

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 “Gerard”