FDA applicant

Jeil Medical Corporation

Seoul, KR53 decisions2002–20260 recalls

FDA records 53 decisions for Jeil Medical Corporation (Seoul, KR) from 2002 to 2026: 53 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and JEY (Plate, Bone). Since 2016 its 510(k)s took a median of 124 days from receipt to decision, against 109 for FDA’s reviews in the same codes and years. Its devices cite 118 predicates, 41 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 Jeil Medical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

6in 2025

2007high 8 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Jeil Medical Corporation’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 “Jeil”

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

Jeil Tech Co., Ltd. 1

Jeil Medical Corporation

Which product codes does it file in?

How long do its 510(k) reviews take?

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 “Jeil”