510(k) Report

FDA applicant

Amtech Scientific, Inc.

Mchenry, IL1 decision1984–19840 recalls

FDA records 1 decision for Amtech Scientific, Inc. (Mchenry, IL) in 1984: 1 510(k) clearance. All are in product code HWX (Tap, Bone). 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 Amtech Scientific, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Amtech Scientific, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Amtech Scientific, 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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