FDA applicant

Owens Industries, Inc.

Oak Creek, WI4 decisions1994–19940 recalls

FDA records 4 decisions for Owens Industries, Inc. (Oak Creek, WI) in 1994: 4 510(k) clearances. Most are in product codes HET (Laparoscope, Gynecologic (And Accessories)) and GCJ (Laparoscope, General & Plastic Surgery). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Owens Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Owens”

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

Owens & Minor (O&M) Halyard, Inc. 12 Owens Precision Systems, Inc. 3 Owens-Brigam Medical Co. 2 Owens & Minor Halyard, Inc. 2 Owens-Illinois, Inc. 1

Owens Industries, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Owens”