FDA applicant
Amatech International, Inc.
FDA records 3 decisions for Amatech International, Inc. (Houston, TX) from 1986 to 1988: 3 510(k) clearances. Most are in product codes JJB (Azo-Dyes, Colorimetric, Bilirubin & Its…) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). 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 Amatech International, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Amatech International, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Amatech International, 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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