FDA applicant

Kyung Won Medical Co., Ltd.

Santa Fe Springs, CA4 decisions2007–20100 recalls

FDA records 4 decisions for Kyung Won Medical Co., Ltd. (Santa Fe Springs, CA) from 2007 to 2010: 4 510(k) clearances. Most are in product codes GXP (Methyl Methacrylate For Cranioplasty) and MNH (Orthosis, Spondylolisthesis Spinal Fixation). Its devices cite 5 predicates, 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, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Kyung Won Medical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2007high 2 (2010) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kyung Won Medical 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

Other applicant names beginning “Kyung”

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

Kyung GI Medical Ind. Co., Ltd. 1

Kyung Won Medical Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Kyung”