FDA applicant
Med USA
FDA records 5 decisions for Med USA (Waltham, MA) from 1985 to 1990: 5 510(k) clearances. Most are in product codes KQG (Instrument, Coagulation) and GKL (Counter, Cell, Automated (Particle Counter)). 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 Med USA’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Med USA since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Med USA’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