FDA applicant
Plus EV Holdings Dba Intimate Rose
FDA records 3 decisions for Plus EV Holdings Dba Intimate Rose (North Kansas City, MO) from 2020 to 2024: 3 510(k) clearances. Most are in product codes HDX (Dilator, Vaginal) and HIR (Perineometer). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Plus EV Holdings Dba Intimate Rose’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Plus EV Holdings Dba Intimate Rose’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 “Plus”
FDA records each applicant name separately; these may or may not be the same firm.