FDA applicant

Owens Precision Systems, Inc.

Oak Creek, WI3 decisions1994–19940 recalls

FDA records 3 decisions for Owens Precision Systems, Inc. (Oak Creek, WI) in 1994: 3 510(k) clearances. Most are in product codes HET (Laparoscope, Gynecologic (And Accessories)) and HFB (Forceps, Biopsy, Gynecological). 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 Precision Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Owens Precision Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Owens Precision Systems, 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 Industries, Inc. 4 Owens-Brigam Medical Co. 2 Owens & Minor Halyard, Inc. 2 Owens-Illinois, Inc. 1

Owens Precision Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Owens”