FDA applicant
Ballard Medical Products
FDA records 26 decisions for Ballard Medical Products (Draper, UT) from 1982 to 2003: 26 510(k) clearances. Most are in product codes BSY (Catheters, Suction, Tracheobronchial) and GEC (Brush, Scrub, Operating-Room). Its devices cite 7 predicates, 1 of them its own earlier devices. 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ballard Medical Products’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ballard Medical Products since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ballard Medical Products’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