FDA applicant

Darco International, Inc.

Huntington, WV2 decisions2006–20063 recalls

FDA records 2 decisions for Darco International, Inc. (Huntington, WV) in 2006: 2 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Its devices cite 2 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Darco International, Inc. since 2007.

Recalls per year

1in 2022

2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Darco”

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

Darco Water Systems, Inc. 1 Darco Intl., Inc. 1

Darco International, 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?

What has been recalled?

Other applicant names beginning “Darco”