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510k Database
Manufacturers
FR
Onefit Medical
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Medical Device Manufacturer
·
FR , Besan?on
Onefit Medical - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2014
Recent clearances:
hipEOS
,
kneeEOS
,
hipEOS
View 5 510(k) Devices ↓
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Onefit Medical
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
Apr 27, 2018
hipEOS
K173390
·
LLZ
Radiology
·
179d
Cleared
Oct 03, 2016
kneeEOS
K161828
·
LLZ
Radiology
·
90d
Cleared
Jun 28, 2016
hipEOS
K161479
·
LLZ
Radiology
·
28d
Cleared
Apr 08, 2016
spineEOS
K160407
·
LLZ
Radiology
·
52d
Cleared
Dec 05, 2014
ONEFIT HIP PLANNER
K142671
·
LLZ
Radiology
·
77d
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5
Radiology
5