FDA applicant
Heraeus Medical GmbH
FDA records 13 decisions for Heraeus Medical GmbH (Wehrheim, DE) from 2014 to 2024: 13 510(k) clearances. Most are in product codes LOD (Bone Cement) and KWY (Prosthesis, Hip, Hemi-, Femoral…). Since 2016 its 510(k)s took a median of 109 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 5 of them its own earlier devices. 8 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Heraeus Medical GmbH’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
4in 2026
Class I Class II/III not classified
Planning a device like Heraeus Medical 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 “Heraeus”
FDA records each applicant name separately; these may or may not be the same firm.