Osstell AB

FDA Regulatory Profile

Osstell AB appears in FDA public data with 0 recalls, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 8, 2026.

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K261987Reusable SmartPegSeptember 8, 2026
K181888Osstell BeaconAugust 22, 2019
K142358Osstell IDxFebruary 19, 2015
K132401MEGA ISQApril 9, 2014
K082523OSSTELL ISQ IMPLANT STABILITY METERSeptember 26, 2008