FDA applicant

Sanofi, Inc.

Cambridge, MA2 decisions2017–20170 recalls

FDA records 2 decisions for Sanofi, Inc. (Cambridge, MA) in 2017: 2 510(k) clearances. All are in product code NDC (Calculator, Drug Dose). No recall is linked to its devices.

FDA’s records also spell it “Sanofi”.

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 Sanofi, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Sanofi, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Sanofi”

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

Sanofi Aventis U.S., LLC 1 Sanofi Genzyme Corp. 1

Sanofi, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sanofi”