FDA applicant

Henry Schein, Inc.

Mchenry, IL8 decisions1978–20048 recalls

FDA records 8 decisions for Henry Schein, Inc. (Mchenry, IL) from 1978 to 2004: 8 510(k) clearances. Most are in product codes EFN (Cotton, Roll) and EAX (Mirror, Mouth). 8 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, dental panel, where it files most

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

FDA decisions per year

No FDA decision for Henry Schein, Inc. since 2007.

Recalls per year

8in 2008

2007high 8 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Henry Schein, 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 “Henry”

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

The Henry G. Dietz Co., Inc. 2 Henry Enterprises, Inc. 1 Henry Ford Hospital 1

Henry Schein, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Henry”