FDA applicant
H.C. Starck Ceramics GmbH
FDA records 4 decisions for H.C. Starck Ceramics GmbH (North Reading, MA) from 2008 to 2015: 4 510(k) clearances. All are in product code EIH (Powder, Porcelain). Its devices cite 9 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “H.C. Starck Ceramics GmbH & Co.Kg”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided H.C. Starck Ceramics GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like H.C. Starck Ceramics 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