FDA applicant
Riverain Medical Group,Llc
FDA records 4 decisions for Riverain Medical Group,Llc (Miamisburg, OH) from 2001 to 2011: 3 510(k) clearances and 1 original PMA approval. Most are in product codes LLZ (System, Image Processing, Radiological) and MYN (Analyzer, Medical Image). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Riverain Medical Group”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Riverain Medical Group,Llc’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Riverain Medical Group,Llc’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 “Riverain”
FDA records each applicant name separately; these may or may not be the same firm.