FDA applicant
Miles, Inc.
FDA records 11 decisions for Miles, Inc. (Tarrytown, NY) from 1993 to 1995: 11 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and CGX (Alkaline Picrate, Colorimetry, Creatinine). 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 Miles, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Miles, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Miles, Inc.’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 “Miles”
FDA records each applicant name separately; these may or may not be the same firm.