FDA applicant

Institut Biochimique SA (Ibsa)

Huntington Beach, CA1 decision2002–20020 recalls

FDA records 1 decision for Institut Biochimique SA (Ibsa) (Huntington Beach, CA) in 2002: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 2 predicates, 0 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

How often FDA has decided Institut Biochimique SA (Ibsa)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Institut Biochimique SA (Ibsa) since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Institut Biochimique SA (Ibsa) by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Institut Biochimique SA (Ibsa)’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Institut”

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

Institut Straumann AG 92 Institut Georges Lopez 3 Institut National Des Radioelements 2 Institut Geroges Lopez 1

Institut Biochimique SA (Ibsa)

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Institut”