FDA applicant
Sumi Salud C.A.
FDA records 1 decision for Sumi Salud C.A. (Front Royal, VA) in 1997: 1 510(k) clearance. All are in product code FMI (Needle, Hypodermic, Single Lumen). 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 Sumi Salud C.A.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Sumi Salud C.A. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sumi Salud C.A.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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