FDA applicant

Artivion, Inc.

Kennesaw, GA2 decisions2025–20260 recalls

FDA records 2 decisions for Artivion, Inc. (Kennesaw, GA) from 2025 to 2026: 1 510(k) clearance and 1 original PMA approval. Most are in product codes OHA (Heart Valve, More Than Minimally Manipulated…) and QSK (Hybrid Stent Graft, Thoracic Aortic Lesion…). 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 Artivion, 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 — Artivion, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Artivion, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?