FDA applicant

Grace Medical, Inc.

Memphis, TN15 decisions1994–20261 recall

FDA records 15 decisions for Grace Medical, Inc. (Memphis, TN) from 1994 to 2026: 15 510(k) clearances. Most are in product codes ETB (Prosthesis, Partial Ossicular Replacement) and ETD (Tube, Tympanostomy). Its devices cite 30 predicates, 9 of them its own earlier devices. 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2023

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2007high 1 (2026) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Grace 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 “Grace”

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

Grace River Ent., Inc. 2 The Grace Mfg. Co. 1

Grace Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

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 “Grace”