FDA applicant
Isto Technologies, Inc.
FDA records 4 decisions for Isto Technologies, Inc. (Chevy Chase, MD) from 2007 to 2011: 4 510(k) clearances. All are in product code MQV (Filler, Bone Void, Calcium Compound). Its devices cite 7 predicates, 5 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 Isto Technologies, Inc.’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 2007.
Planning a device like Isto Technologies, 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