510(k) Report

FDA applicant

Novo Nordisk A/S

Princeton, NJ1 decision2001–20010 recalls

FDA records 1 decision for Novo Nordisk A/S (Princeton, NJ) in 2001: 1 510(k) clearance. All are in product code FMF (Syringe, Piston). 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 Novo Nordisk A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Novo Nordisk A/S since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Novo Nordisk A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMFSyringe, Piston1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K010359InnovoNovo Nordisk A/S · 20012cite it

What has FDA decided for it lately?

  • K010359InnovoNovo Nordisk A/S · 2001

The one decision as Novo Nordisk A/S →

Other applicant names beginning “Novo”

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

Novo Nordisk, Inc. 14Novo Nordisk Diagnostics, Ltd. 2Novo Diagnostic Systems 2Novo Nordisk Pharmaceuticals, Inc. 2Novo Norodisk Pharmaceuticals, Inc. 1