FDA applicant
Hoffrichter GmbH
FDA records 3 decisions for Hoffrichter GmbH (Egale, WI) from 2003 to 2006: 3 510(k) clearances. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 5 predicates, 2 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
How often FDA has decided Hoffrichter GmbH’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Hoffrichter GmbH since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hoffrichter GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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