FDA applicant

Fresenius Kabi Deutschland GmbH

Bad Homburg, DE1 decision2006–20060 recalls

FDA records 1 decision for Fresenius Kabi Deutschland GmbH (Bad Homburg, DE) in 2006: 1 510(k) clearance. All are in product code LZH (Pump, Infusion, Enteral). Its devices cite 3 predicates, 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, general hospital panel, where it files most

How often FDA has decided Fresenius Kabi Deutschland GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fresenius Kabi Deutschland GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fresenius Kabi Deutschland GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fresenius Kabi 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 “Fresenius”

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

Fresenius Medical Care Renal Therapies Group, LLC 53 Fresenius Medical Care North America 43 Fresenius USA, Inc. 38 Fresenius Kabi AG 14 Fresenius Medical Care 7 Fresenius Medical Care North America, Design Cente 5 Fresenius Hemotechnology, Inc. 3 Fresenius Pharma 3 Fresenius AG 2 Fresenius Medical Care South Asia Pacific Pty, Ltd. 2 Fresenius Kabi USA,Llc 2 Fresenius/Delmed, Inc. 2

Fresenius Kabi Deutschland GmbH

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Fresenius”