FDA applicant

Ceragem Medisys, Inc.

Cheonan, Chungcheongnam-Do, KR4 decisions2013–20140 recalls

FDA records 4 decisions for Ceragem Medisys, Inc. (Cheonan, Chungcheongnam-Do, KR) from 2013 to 2014: 4 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and LFR (Glucose Dehydrogenase, Glucose). Its devices cite 4 predicates, 2 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, clinical chemistry panel, where it files most

How often FDA has decided Ceragem Medisys, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2014

2013high 3 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Ceragem Medisys, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ceragem Medisys, Inc.’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 “Ceragem”

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

Ceragem Co., Ltd. 7 Ceragem International, Inc. 3

Ceragem Medisys, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Ceragem”