FDA applicant
Valmed Corp.
FDA records 8 decisions for Valmed Corp. (Singer Island, FL) from 1993 to 2019: 8 510(k) clearances. Most are in product codes KPE (Container, I.V.) and IPF (Stimulator, Muscle, Powered). Its devices cite 6 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Valmed S.R.L.”, “Valmed, Inc.”, “Valmed, SA”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Valmed Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Valmed Corp.’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