510k
Database
Specialties
Anesthesiology
133
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569
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163
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313
Ear, Nose, Throat
68
Gastroenterology & Urology
288
General & Plastic Surgery
515
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372
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67
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56
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0
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232
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167
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61
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49
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1292
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18
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86
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868
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
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Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
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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Neurosoft , Ltd.
Medical Device Manufacturer
·
IT , Abano Terme, Padova
Neurosoft , Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2015
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Neurosoft , Ltd.
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 30, 2022
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
K220254
·
OLT
Neurology
·
303d
Cleared
May 22, 2021
Neuro-IOM system with Neuro-IOM.NET software
K190703
·
GWF
Neurology
·
796d
Cleared
Jun 19, 2015
NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
K133995
·
OLT
Neurology
·
540d
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3
Neurology
3