FDA applicant

Owens-Brigam Medical Co.

Newland, NC2 decisions1995–19970 recalls

FDA records 2 decisions for Owens-Brigam Medical Co. (Newland, NC) from 1995 to 1997: 2 510(k) clearances. Most are in product codes BSJ (Mask, Gas, Anesthetic) and BTM (Ventilator, Emergency, Manual (Resuscitator)). 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, anesthesiology panel, where it files most

How often FDA has decided Owens-Brigam Medical Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Owens-Brigam Medical Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Owens-Brigam Medical Co.’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 “Owens-Brigam”

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

Owens & Minor (O&M) Halyard, Inc. 12 Owens Industries, Inc. 4 Owens Precision Systems, Inc. 3 Owens & Minor Halyard, Inc. 2 Owens-Illinois, Inc. 1

Owens-Brigam Medical Co.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Owens-Brigam”