510(k) Report

FDA applicant

Merck Biomaterial GmbH

Darmstadt, DE1 decision2001–20010 recalls

FDA records 1 decision for Merck Biomaterial GmbH (Darmstadt, DE) in 2001: 1 510(k) clearance. All are in product code LOD (Bone Cement). 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 Merck Biomaterial GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Merck Biomaterial GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Merck Biomaterial 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?

  • LODBone Cement1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K010586Palamed Bone CementMerck Biomaterial GmbH · 20011cites it

What has FDA decided for it lately?

  • K010586Palamed Bone CementMerck Biomaterial GmbH · 2001

The one decision as Merck Biomaterial GmbH →

Other applicant names beginning “Merck”

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

Merck, Sharp & Dohme 4Merck Millipore, Ltd. 2