FDA applicant

Civco Medical Instruments CO Inc Dba Civco Medical Solutions

Kalona, IA1 decision2015–20150 recalls

FDA records 1 decision for Civco Medical Instruments CO Inc Dba Civco Medical Solutions (Kalona, IA) in 2015: 1 510(k) clearance. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 1 predicate, 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, radiology panel, where it files most

How often FDA has decided Civco Medical Instruments CO Inc Dba Civco Medical Solutions’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Civco Medical Instruments CO Inc Dba Civco Medical Solutions by year, 2015–2026Sources: 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 2 Civco Medical Solutions 2

Civco Medical Instruments CO Inc Dba Civco Medical Solutions

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Civco”