510k
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Anesthesiology
134
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569
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165
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317
Ear, Nose, Throat
68
Gastroenterology & Urology
289
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522
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374
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67
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57
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0
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234
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172
Obstetrics & Gynecology
62
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51
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1295
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18
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87
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871
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
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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Kalitec Medical
Medical Device Manufacturer
·
US , Orlando , FL
Kalitec Medical - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2023
1
Total
1
Cleared
0
Denied
FDA 510(k) cleared devices by Kalitec Medical
Orthopedic
✕
1
devices
1-1 of 1
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Cleared
Sep 15, 2023
NIDO™ Pedicle Screw System
K230974
·
NKB
Orthopedic
·
163d
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Orthopedic
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