FDA applicant
American Medical Mfg., Inc.
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
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.
Planning a device like American Medical Mfg., 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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