510(k) Report

FDA applicant

Schneider (Europe) GmbH

Bulach, SE5 decisions1995–19990 recalls

FDA records 5 decisions for Schneider (Europe) GmbH (Bulach, SE) from 1995 to 1999: 5 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and ESW (Prosthesis, Esophageal). Its devices cite 2 predicates, 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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Schneider (Europe) GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Schneider (Europe) GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Schneider (Europe) GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Schneider”

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