510(k) Report

FDA applicant

Ammerman Medical Enterprises, Inc.

Naples, FL1 decision1986–19860 recalls

FDA records 1 decision for Ammerman Medical Enterprises, Inc. (Naples, FL) in 1986: 1 510(k) clearance. All are in product code LPZ (Container, Frozen Donor Tissue Storage). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Ammerman Medical Enterprises, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ammerman Medical Enterprises, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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