FDA applicant
American Medical Ceramics, Inc.
FDA records 11 decisions for American Medical Ceramics, Inc. (Knoxville, TN) in 1990: 11 510(k) clearances. All are in product code EKJ (Burnisher, Operative). 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 American Medical Ceramics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for American Medical Ceramics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like American Medical Ceramics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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