510(k) Report

FDA applicant

Beiersdorf, Inc.

Norwalk, CT48 decisions1977–20090 recalls

FDA records 48 decisions for Beiersdorf, Inc. (Norwalk, CT) from 1977 to 2009: 48 510(k) clearances. Most are in product codes KGX (Tape And Bandage, Adhesive) and FPX (Strip, Adhesive, Closure, Skin). Its devices cite 18 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Beiersdorf AG”.

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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Beiersdorf, Inc.’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 “Beiersdorf”

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