FDA applicant
Mediscitec, Inc.
FDA records 2 decisions for Mediscitec, Inc. (Littleton, CO) from 2008 to 2010: 2 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). 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 Mediscitec, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2008high 1 (2008) · low 0 (2009)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Mediscitec, 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