FDA applicant
Prodeon Medical, Inc.
FDA records 3 decisions for Prodeon Medical, Inc. (Sunnyvale, CA) from 2025 to 2026: 3 510(k) clearances. Most are in product codes QKA (Temporarily-Placed Urethral Opening System For…) and FED (Endoscopic Access Overtube…). Its devices cite 3 predicates, 1 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 Prodeon Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Prodeon Medical, 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