FDA applicant

Bear Medical Systems, Inc.

Riverside, CA28 decisions1982–19990 recalls

FDA records 28 decisions for Bear Medical Systems, Inc. (Riverside, CA) from 1982 to 1999: 28 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and BZK (Spirometer, Monitoring (W/Wo Alarm)). Its devices cite 6 predicates, 1 of them its own earlier devices. 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 Bear Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bear Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Bear Medical Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?