FDA applicant

Bowen & Company, Inc.

Rockville, MD14 decisions1985–19900 recalls

FDA records 14 decisions for Bowen & Company, Inc. (Rockville, MD) from 1985 to 1990: 14 510(k) clearances. Most are in product codes HXI (Passer, Wire, Orthopedic) and HTW (Bit, Drill). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Bowen & Company, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bowen & Company, 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 “Bowen”

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

Bowen Medical Services, Inc. 1

Bowen & Company, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Bowen”