FDA applicant
Bouvier Hydro, Inc.
FDA records 2 decisions for Bouvier Hydro, Inc. (Champlain,, NY) in 1998: 2 510(k) clearances. All are in product code ILJ (Bath, Hydro-Massage). 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 Bouvier Hydro, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bouvier Hydro, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bouvier Hydro, 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) Report