510(k) Report

FDA applicant

Medizin Produkte Neustadt GmbH (Mpn)

Saal/Donau Bavaria, DE1 decision2025–20250 recalls

FDA records 1 decision for Medizin Produkte Neustadt GmbH (Mpn) (Saal/Donau Bavaria, DE) in 2025: 1 510(k) clearance. All are in product code OLR (Oral Wound Dressing). 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 Medizin Produkte Neustadt GmbH (Mpn)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Medizin Produkte Neustadt GmbH (Mpn) by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Medizin”

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