FDA applicant

Sanofi Aventis U.S., LLC

Bridgewater1 decision1976–19760 recalls

FDA records 1 decision for Sanofi Aventis U.S., LLC (Bridgewater) in 1976: 1 original PMA approval. 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, ophthalmic panel, where it files most

How often FDA has decided Sanofi Aventis U.S., LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sanofi Aventis U.S., LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sanofi Aventis U.S., LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Sanofi”

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

Sanofi, Inc. 2 Sanofi Genzyme Corp. 1

Sanofi Aventis U.S., LLC

What has FDA decided for it lately?

Other applicant names beginning “Sanofi”