FDA applicant
Biografik (Malaysia) Sdn Bhd
FDA records 2 decisions for Biografik (Malaysia) Sdn Bhd (Nilai, Negeri Sembilan, MY) from 1996 to 1999: 2 510(k) clearances. All are in product code LYY (Latex Patient Examination Glove). 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 Biografik (Malaysia) Sdn Bhd’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Biografik (Malaysia) Sdn Bhd since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Biografik (Malaysia) Sdn Bhd’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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