FDA applicant
Ameco Medical Industries
FDA records 6 decisions for Ameco Medical Industries (Monroe, CT) from 2011 to 2016: 6 510(k) clearances. Most are in product codes MSD (Catheter, Hemodialysis, Implanted) and LJS (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 Ameco Medical Industries’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2011high 3 (2013) · low 0 (2012)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Ameco Medical Industries’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) Report