FDA applicant

I.C Medical, Inc.

Phoenix, AZ16 decisions1990–20170 recalls

FDA records 16 decisions for I.C Medical, Inc. (Phoenix, AZ) from 1990 to 2017: 16 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and FYD (Apparatus, Exhaust, Surgical). Its devices cite 5 predicates, 5 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2017

2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like I.C Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

I.C Medical, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?