510(k) Report

FDA applicant

Amsco Intl., Inc.

Erie, PA1 decision1998–19982 recalls

FDA records 1 decision for Amsco Intl., Inc. (Erie, PA) in 1998: 1 510(k) clearance. All are in product code FLE (Sterilizer, Steam). 2 recalls are 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 hospital panel, where it files most

How often FDA has decided Amsco Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Amsco Intl., Inc. since 2007.

Recalls per year

1in 2019

2008: 12019: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Amsco”

FDA records each applicant name separately; these may or may not be the same firm.