FDA applicant

Zcv,Inc.

Edison, NJ6 decisions1999–20010 recalls

FDA records 6 decisions for Zcv,Inc. (Edison, NJ) from 1999 to 2001: 6 510(k) clearances. Most are in product codes LDF (Electrode, Pacemaker, Temporary) and DRF (Catheter, Electrode Recording, Or Probe…). Its devices cite 2 predicates, 0 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Zcv,Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Zcv,Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?