FDA applicant
Rj Medical, Inc.
FDA records 2 decisions for Rj Medical, Inc. (El Dorado Hills, CA) in 2008: 2 510(k) clearances. Most are in product codes HCG (Device, Neurovascular Embolization) and KRD (Device, Vascular, For Promoting Embolization). Its devices cite 9 predicates, 0 of them its own earlier devices. 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 Rj Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2008
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Rj Medical, 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) Report