FDA applicant

Biomedical Devices, Inc.

Irvine, CA7 decisions1983–19957 recalls

FDA records 7 decisions for Biomedical Devices, Inc. (Irvine, CA) from 1983 to 1995: 7 510(k) clearances. Most are in product codes FXY (Hood, Surgical) and FRN (Pump, Infusion). 7 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Biomedical Devices, Inc. since 2007.

Recalls per year

7in 2023

2007high 7 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

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Biomedical Devices, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?