FDA applicant

Grace River Ent., Inc.

New York, NY2 decisions1990–19910 recalls

FDA records 2 decisions for Grace River Ent., Inc. (New York, NY) from 1990 to 1991: 2 510(k) clearances. Most are in product codes ILY (Lamp, Infrared, Therapeutic Heating) and LYY (Latex Patient Examination Glove). 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, physical medicine panel, where it files most

How often FDA has decided Grace River Ent., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Grace River Ent., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Grace River Ent., 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 “Grace”

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

Grace Medical, Inc. 15 The Grace Mfg. Co. 1

Grace River Ent., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Grace”