510(k) Report

FDA applicant

American Medical Mfg., Inc.

Calabasas, CA6 decisions1992–19990 recalls

FDA records 6 decisions for American Medical Mfg., Inc. (Calabasas, CA) from 1992 to 1999: 6 510(k) clearances. Most are in product codes FZZ (Marker, Skin) and FOZ (Catheter, Intravascular, Therapeutic…). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for American Medical Mfg., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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