FDA applicant
Mill-Rose Laboratory
FDA records 46 decisions for Mill-Rose Laboratory (Mentor, OH) from 1979 to 1998: 46 510(k) clearances. Most are in product codes EOQ (Bronchoscope (Flexible Or Rigid)) and GEN (Forceps, General & Plastic Surgery). Its devices cite 11 predicates, 7 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Mill-Rose Laboratory’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Mill-Rose Laboratory since 2007.
Recalls per year
4in 2012
Class I Class II/III not classified
Planning a device like Mill-Rose Laboratory’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 “Mill-Rose”
FDA records each applicant name separately; these may or may not be the same firm.