FDA applicant
Zimmer Medizinsysteme GmbH
FDA records 13 decisions for Zimmer Medizinsysteme GmbH (Neu-Elm, DE) from 2016 to 2026: 13 510(k) clearances. Most are in product codes NGX (Stimulator, Muscle, Powered, For Muscle…) and PBX (Massager, Vacuum, Radio Frequency Induced Heat). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 160 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 3 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
How often FDA has decided Zimmer Medizinsysteme GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Zimmer Medizinsysteme 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) ReportOther applicant names beginning “Zimmer”
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