510k
Database
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Anesthesiology
134
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569
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165
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316
Ear, Nose, Throat
68
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289
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522
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373
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67
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57
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0
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233
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171
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62
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50
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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
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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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Homtex, Inc.
Medical Device Manufacturer
·
US , Cullman , AL
Homtex, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Homtex, Inc.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 19, 2021
Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America...
K211066
·
FXX
General Hospital
·
129d
Cleared
Mar 19, 2021
Sovereign America Surgical Face Mask
K201095
·
FXX
General Hospital
·
329d
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2
General Hospital
2