FDA applicant
Rowenta, Inc.
FDA records 1 decision for Rowenta, Inc. (Medford, MA) in 2003: 1 510(k) clearance. All are in product code MNW (Analyzer, Body Composition). 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 Rowenta, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Rowenta, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Rowenta, 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