510(k) Report

FDA applicant

Owens-Illinois, Inc.

El Paso, TX1 decision1978–19780 recalls

FDA records 1 decision for Owens-Illinois, Inc. (El Paso, TX) in 1978: 1 510(k) clearance. All are in product code GJG (Pipette, Quantitative, Hematology). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Owens-Illinois, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Owens-Illinois, 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-Illinois”

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