510(k) Report

FDA applicant

Cybermed, Inc.

Seoul, KR6 decisions2001–20220 recalls

FDA records 6 decisions for Cybermed, Inc. (Seoul, KR) from 2001 to 2022: 6 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and DZE (Implant, Endosseous, Root-Form). Its devices cite 13 predicates, 4 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, radiology panel, where it files most

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

FDA decisions per year

1in 2022

2007: 12011: 12022: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cybermed, 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 “Cybermed”

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