FDA applicant
AgNovos Healthcare USA, LLC
FDA records 2 decisions for AgNovos Healthcare USA, LLC (Rockville, MD) in 2018: 2 510(k) clearances. All are in product code MQV (Filler, Bone Void, Calcium Compound). 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 AgNovos Healthcare USA, LLC’s devices, and how often a recall has named them.
FDA decisions per year
2in 2018
2018high 2 (2018) · low 0 (2019)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like AgNovos Healthcare USA, 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) Report