510(k) Report

FDA applicant

Modern Healthcare Corp.

Hsin-Chu City, TW3 decisions2007–20200 recalls

FDA records 3 decisions for Modern Healthcare Corp. (Hsin-Chu City, TW) from 2007 to 2020: 3 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and KGO (Surgeon'S Gloves). Its devices cite 2 predicates, 1 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, general and plastic surgery panel, where it files most

How often FDA has decided Modern Healthcare Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007: 12019: 12020: 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 — Modern Healthcare Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Modern Healthcare Corp.’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 “Modern”

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