FDA applicant
Bailey Medical Engineering
FDA records 2 decisions for Bailey Medical Engineering (Los Osos, CA) from 1995 to 2002: 2 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). 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 Bailey Medical Engineering’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bailey Medical Engineering since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bailey Medical Engineering’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) ReportOther applicant names beginning “Bailey”
FDA records each applicant name separately; these may or may not be the same firm.