510(k) Report

FDA applicant

Schwarzer GmbH

Munich, DE1 decision2002–20020 recalls

FDA records 1 decision for Schwarzer GmbH (Munich, DE) in 2002: 1 510(k) clearance. All are in product code DQK (Computer, Diagnostic, Programmable). 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 Schwarzer GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Schwarzer GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Schwarzer 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 “Schwarzer”

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