FDA applicant

Cares Built, Inc.

Keyport, NJ4 decisions2001–20010 recalls

FDA records 4 decisions for Cares Built, Inc. (Keyport, NJ) in 2001: 4 510(k) clearances. Most are in product codes OXO (Image-Intensified Fluoroscopic X-Ray System…) and JAA (System, X-Ray, Fluoroscopic, Image-Intensified). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Cares Built, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Cares Built, Inc.

Which product codes does it file in?

What has FDA decided for it lately?