FDA applicant

Mondeal Medical Systems GmbH

San Diego, CA6 decisions2005–20070 recalls

FDA records 6 decisions for Mondeal Medical Systems GmbH (San Diego, CA) from 2005 to 2007: 6 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and DZE (Implant, Endosseous, Root-Form). Its devices cite 7 predicates, 2 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 Mondeal Medical Systems GmbH’s devices, and how often a recall has named them.

FDA decisions per year

4in 2007

2007high 4 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mondeal Medical Systems GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Mondeal”

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

Mondeal North America, Inc. 1

Mondeal Medical Systems GmbH

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 “Mondeal”