FDA applicant
Spenco Medical Corp.
FDA records 10 decisions for Spenco Medical Corp. (Waco, TX) from 1979 to 1998: 10 510(k) clearances. Most are in product codes KMF (Bandage, Liquid) and MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…). 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 Spenco Medical Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Spenco Medical Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Spenco Medical Corp.’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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