510(k) Report

FDA applicant

Rossmax International, Ltd.

Taipei, TW16 decisions1998–20060 recalls

FDA records 16 decisions for Rossmax International, Ltd. (Taipei, TW) from 1998 to 2006: 16 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and DPW (Flowmeter, Blood, Cardiovascular). 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, cardiovascular panel, where it files most

How often FDA has decided Rossmax International, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rossmax International, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Rossmax International, 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 “Rossmax”

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