FDA applicant
Amsco Intl., Inc.
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
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
2007high 1 (2008) · low 0 (2007)2026
Class I Class II/III not classified
Planning a device like Amsco Intl., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Amsco”
FDA records each applicant name separately; these may or may not be the same firm.