FDA applicant

Medica USA, Inc.

Minnetonka, MN1 decision2025–20250 recalls

FDA records 1 decision for Medica USA, Inc. (Minnetonka, MN) in 2025: 1 510(k) clearance. All are in product code KDI (Dialyzer, High Permeability With Or Without…). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2025

2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Medica USA, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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See the 510(k) Report

Other applicant names beginning “Medica”

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

Medica Corp. 56 Medica Holdings, LLC 3 Medica-Rents Co., Ltd. 1 Medica Health, Ltd. 1

Medica USA, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Medica”