510k
Database
Specialties
Anesthesiology
132
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568
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162
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
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513
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370
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67
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56
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0
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232
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163
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61
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49
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1288
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18
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85
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866
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Dixi Medical
Medical Device Manufacturer
·
FR , Chaudefontaine
Dixi Medical - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2017
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Dixi Medical
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 18, 2021
DIXI Medical Microdeep Micro-Macro Depth Electrodes
K202087
·
GZL
Neurology
·
478d
Cleared
Oct 02, 2021
Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
K201931
·
GYC
Neurology
·
446d
Cleared
Nov 24, 2017
DIXI Medical Microdeep Depth Electrode
K170959
·
GZL
Neurology
·
238d
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3
Neurology
3