FDA applicant

Kaen Yih Enterprise Co., Ltd.

Mc Henry, IL1 decision2004–20040 recalls

FDA records 1 decision for Kaen Yih Enterprise Co., Ltd. (Mc Henry, IL) in 2004: 1 510(k) clearance. All are in product code HFW (Clamp, Umbilical). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Kaen Yih Enterprise Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kaen Yih Enterprise Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kaen Yih Enterprise Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Kaen”

FDA records each applicant name separately; these may or may not be the same firm.

Kaen Yang Industry Co., Ltd. 1

Kaen Yih Enterprise Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Kaen”