FDA applicant
Royal Oak Medical Devices
FDA records 2 decisions for Royal Oak Medical Devices (Bloomfield Hills, MI) in 2011: 2 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 11 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 Royal Oak Medical Devices’s devices, and how often a recall has named them.
FDA decisions per year
2in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Royal Oak Medical Devices’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 “Royal”
FDA records each applicant name separately; these may or may not be the same firm.