FDA applicant
Bio-Medical Carbon Technology Co., Ltd.
FDA records 1 decision for Bio-Medical Carbon Technology Co., Ltd. (Austin, TX) in 2014: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 1 predicate, 0 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 Bio-Medical Carbon Technology Co., Ltd.’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 2014.
Planning a device like Bio-Medical Carbon 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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