FDA applicant
Contra Healthcare Solutions, LLC
FDA records 2 decisions for Contra Healthcare Solutions, LLC (Butler, PA) in 2025: 2 510(k) clearances. Most are in product codes FGB (Ureteroscope And Accessories, Flexible/Rigid) and EOQ (Bronchoscope (Flexible Or Rigid)). Its devices cite 2 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 Contra Healthcare Solutions, LLC’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Contra Healthcare Solutions, LLC’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