FDA applicant
Cobes Industries Co., Ltd.
FDA records 3 decisions for Cobes Industries Co., Ltd. (Dover, DE) from 2012 to 2014: 3 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and KKX (Drape, Surgical, Antimicrobial). 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 Cobes Industries Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2012high 1 (2012) · low 0 (2015)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Cobes Industries Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report