FDA applicant

Qualimed USA, LLC

Charlotte, NC1 decision2021–20210 recalls

FDA records 1 decision for Qualimed USA, LLC (Charlotte, NC) in 2021: 1 510(k) clearance. All are in product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2021

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Qualimed USA, LLC by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Qualimed”

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

Qualimed Srl 2

Qualimed USA, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Qualimed”