510(k) Report

FDA applicant

Mammendorfer Institute For Physics & Medicine GmbH

Golden, CO3 decisions2003–20060 recalls

FDA records 3 decisions for Mammendorfer Institute For Physics & Medicine GmbH (Golden, CO) from 2003 to 2006: 3 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and DQA (Oximeter). Its devices cite 5 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 Mammendorfer Institute For Physics & Medicine GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mammendorfer Institute For Physics & Medicine GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mammendorfer Institute For Physics & Medicine 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 “Mammendorfer”

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