FDA applicant

Fresenius Pharma

New Brunswick, NJ3 decisions1990–19920 recalls

FDA records 3 decisions for Fresenius Pharma (New Brunswick, NJ) from 1990 to 1992: 3 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and LZH (Pump, Infusion, Enteral). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Fresenius Pharma since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Fresenius Pharma’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 AG 2 Fresenius Medical Care South Asia Pacific Pty, Ltd. 2 Fresenius Kabi USA,Llc 2 Fresenius/Delmed, Inc. 2 Fresenius Hemocare, Inc. 1

Fresenius Pharma

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Fresenius”