510k
Database
Specialties
Anesthesiology
366
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1161
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284
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869
Ear, Nose, Throat
158
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680
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1463
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859
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107
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76
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1
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383
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642
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266
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169
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2159
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41
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347
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1707
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133
Categories
GEX
Powered Laser Surgical Instrument
245
QIH
Automated Radiological Image...
223
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System, Imaging, Pulsed Doppler,...
221
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System, Image Processing,...
218
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Plate, Fixation, Bone
216
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Electrosurgical, Cutting &...
207
OLO
Orthopedic Stereotaxic Instrument
180
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
147
MAX
Intervertebral Fusion Device...
146
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Onefit Medical
Medical Device Manufacturer
·
FR , Besan?on
Onefit Medical - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2014
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