510(k) Report

FDA applicant

American Medical Specialties, Inc.

Norcross, GA4 decisions1994–19960 recalls

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, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

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.

FIG. 1 — American Medical Specialties, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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