FDA applicant

Heraeus Medical GmbH Technology

Wehrheim, DE1 decision2003–20030 recalls

FDA records 1 decision for Heraeus Medical GmbH Technology (Wehrheim, DE) in 2003: 1 510(k) clearance. All are in product code LOD (Bone Cement). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Heraeus Medical GmbH Technology since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Heraeus Medical GmbH Technology 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 Instruments GmbH 1 Heraeus, Inc. 1 Heraeus Kulzer, Inc., Dental Products Division 1

Heraeus Medical GmbH Technology

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Heraeus”