FDA applicant

Zewa, Inc.

Miami, FL4 decisions1992–20040 recalls

FDA records 4 decisions for Zewa, Inc. (Miami, FL) from 1992 to 2004: 4 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and LKX (Device, Thermal, Hemorrhoids). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Zewa AG”.

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 Zewa, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zewa, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Zewa, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?