FDA applicant
Facilai Enterprises, Ltd.
FDA records 1 decision for Facilai Enterprises, Ltd. (Hsin Chu City, TW) in 2003: 1 510(k) clearance. All are in product code MQX (Needle, Acupuncture, Single Use). 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 Facilai Enterprises, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Facilai Enterprises, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Facilai Enterprises, Ltd.’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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