FDA applicant

Heraeus Instruments GmbH

Hanau, DE1 decision1993–19931 recall

FDA records 1 decision for Heraeus Instruments GmbH (Hanau, DE) in 1993: 1 510(k) clearance. All are in product code FTD (Lamp, Surgical). 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 Instruments GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Heraeus Instruments GmbH since 2007.

Recalls per year

1in 2023

2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Heraeus”

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

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

Heraeus Instruments GmbH

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Heraeus”