510(k) Report

FDA applicant

Heraeus Med GmbH

Hanau, DE3 decisions1996–19971 recall

FDA records 3 decisions for Heraeus Med GmbH (Hanau, DE) from 1996 to 1997: 3 510(k) clearances. Most are in product codes FSY (Light, Surgical, Ceiling Mounted) and FSS (Light, Surgical, Floor Standing). 1 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 and plastic surgery panel, where it files most

How often FDA has decided Heraeus Med GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Heraeus Med GmbH since 2007.

Recalls per year

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Heraeus Med GmbH 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?

  • FSYLight, Surgical, Ceiling Mounted2decisions
  • FSSLight, Surgical, Floor Standing1decision

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.

  • K954169Hanaulux Blue 30 & 80Heraeus Med GmbH · 19961cites it
  • K970886Hanaulux Blue 80 HospitalHeraeus Med GmbH · 19971cites it

What has FDA decided for it lately?

  • K973466Hanaulux Blue 75 and Hanaulux Blue 120Heraeus Med GmbH · 1997
  • K970886Hanaulux Blue 80 HospitalHeraeus Med GmbH · 19971 recall
  • K954169Hanaulux Blue 30 & 80Heraeus Med GmbH · 19961 recall

All 3 as Heraeus Med GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K954169Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30…Nov 8, 2023Class II

Other applicant names beginning “Heraeus”

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

Heraeus Kulzer, Inc. 170Heraeus Lasersonics, Inc. 38Heraeus Medical GmbH 13Heraeus Surgical, Inc. 8Heraeus Medical Components, LLC 4Heraeus Dental Gold Corp. 3Heraeus-Christ GmbH 2Heraeus Kulzer, LLC (Mitsui Chemicals Group) 2Heraeus Medical GmbH Technology 1Heraeus Instruments GmbH 1Heraeus, Inc. 1Heraeus Kulzer, Inc., Dental Products Division 1