FDA applicant

Bhs Intl., Inc.

Crofton, MD2 decisions1994–20010 recalls

FDA records 2 decisions for Bhs Intl., Inc. (Crofton, MD) from 1994 to 2001: 2 510(k) clearances. Most are in product codes DQA (Oximeter) and LDE (Stethoscope, Manual). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Bhs Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bhs Intl., 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

Bhs Intl., Inc.

Which product codes does it file in?

What has FDA decided for it lately?