510(k) Report

FDA applicant

Freudenberg Technology Innovation SE & Co. KG

Weinheim, DE1 decision2020–20200 recalls

FDA records 1 decision for Freudenberg Technology Innovation SE & Co. KG (Weinheim, DE) in 2020: 1 510(k) clearance. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 1 predicate, 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 Freudenberg Technology Innovation SE & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Freudenberg Technology Innovation SE & Co. KG by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Freudenberg”

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