FDA applicant
Envitec-Wismar GmbH
FDA records 9 decisions for Envitec-Wismar GmbH (Egale, WI) from 2000 to 2014: 9 510(k) clearances. Most are in product codes DQA (Oximeter) and CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). Its devices cite 21 predicates, 4 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 Envitec-Wismar GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
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