FDA applicant

Fresenius AG

Foster, RI2 decisions1996–19974 recalls

FDA records 2 decisions for Fresenius AG (Foster, RI) from 1996 to 1997: 2 510(k) clearances. All are in product code CAC (Apparatus, Autotransfusion). 4 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Fresenius AG since 2007.

Recalls per year

3in 2010

2007high 3 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

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 Medical Care South Asia Pacific Pty, Ltd. 2 Fresenius Kabi USA,Llc 2 Fresenius/Delmed, Inc. 2 Fresenius Hemocare, Inc. 1

Fresenius AG

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Fresenius”