510(k) Report

FDA applicant

Ebm Technologies Incorporated

Taipei, TW3 decisions2014–20200 recalls

FDA records 3 decisions for Ebm Technologies Incorporated (Taipei, TW) from 2014 to 2020: 3 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Ebm Technologies, Inc.”.

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 Ebm Technologies Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2014: 12017: 12020: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Ebm Technologies Incorporated by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ebm Technologies Incorporated’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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