FDA applicant

Civco

Kalona, IA2 decisions2007–200919 recalls

FDA records 2 decisions for Civco (Kalona, IA) from 2007 to 2009: 2 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and IYE (Accelerator, Linear, Medical). Its devices cite 10 predicates, 0 of them its own earlier devices. 19 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, radiology panel, where it files most

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

FDA decisions per year

1in 2009

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

8in 2026

2007high 8 (2026) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Civco”

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

CIVCO Medical Instruments Co., Inc. 31 Civco Medical Solutions 2 Civco Medical Instruments CO Inc Dba Civco Medical… 1

Civco

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 “Civco”