510(k) Report

FDA applicant

Cobes Industries Co., Ltd.

Dover, DE3 decisions2012–20140 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

2012: 12013: 12014: 1
2012high 1 (2012) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Cobes Industries Co., Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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