FDA applicant
American Medical Specialties, Inc.
FDA records 4 decisions for American Medical Specialties, Inc. (Norcross, GA) from 1994 to 1996: 4 510(k) clearances. Most are in product codes HTY (Pin, Fixation, Smooth) and GFA (Blade, Saw, General & Plastic Surgery, Surgical). 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 Specialties, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for American Medical Specialties, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like American Medical Specialties, Inc.’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