FDA applicant

Livanova Deutschland, GmbH

Munich, DE7 decisions2020–20232 recalls

FDA records 7 decisions for Livanova Deutschland, GmbH (Munich, DE) from 2020 to 2023: 7 510(k) clearances. Most are in product codes DTQ (Console, Heart-Lung Machine, Cardiopulmonary…) and DWC (Controller, Temperature, Cardiopulmonary Bypass). Its devices cite 11 predicates, 4 of them its own earlier devices. 2 recalls are 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 Livanova Deutschland, GmbH’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2020high 3 (2021) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2024

2020high 1 (2023) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Livanova Deutschland, GmbH by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Livanova”

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

LivaNova USA, Inc. 5

Livanova Deutschland, GmbH

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Livanova”