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Onefit Medical

FDA Regulatory Profile

Onefit Medical has 0 FDA recalls, 0 inspections, 5 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Apr 27, 2018

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances5Oct 4, 2026Not statedCurrent
Inspections0Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K173390hipEOSApr 27, 2018
K161828kneeEOSOct 3, 2016
K161479hipEOSJun 28, 2016
K160407spineEOSApr 8, 2016
K142671ONEFIT HIP PLANNERDec 5, 2014

FDA data resources