FDA applicant
Sofilm Technology Co., Ltd.
FDA records 1 decision for Sofilm Technology Co., Ltd. (Taipei County 231, TW) in 2005: 1 510(k) clearance. All are in product code FYA (Gown, Surgical). 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 Sofilm Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Sofilm Technology Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sofilm Technology Co., 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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