FDA applicant

Combe, Inc.

White Plains, NY9 decisions1977–20170 recalls

FDA records 9 decisions for Combe, Inc. (White Plains, NY) from 1977 to 2017: 9 510(k) clearances. Most are in product codes NUC (Lubricant, Personal) and EFT (Cleanser, Denture, Over The Counter). Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Combe Incorporated”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

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

FDA decisions per year

1in 2017

2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Combe, 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

Combe, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?