510k
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1278
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313
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966
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183
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753
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1641
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1039
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114
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82
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6
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405
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707
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315
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192
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2316
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43
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382
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1858
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138
Categories
GEX
Powered Laser Surgical Instrument
275
LLZ
System, Image Processing,...
259
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Automated Radiological Image...
242
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Plate, Fixation, Bone
228
IYN
System, Imaging, Pulsed Doppler,...
227
GEI
Electrosurgical, Cutting &...
227
OLO
Orthopedic Stereotaxic Instrument
188
NHA
Abutment, Implant, Dental,...
175
LZA
Polymer Patient Examination Glove
160
NKB
Thoracolumbosacral Pedicle Screw...
158
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Qualgenix, LLC
Medical Device Manufacturer
·
US , Oxford , CT
Qualgenix, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2012
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Qualgenix, LLC
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 20, 2012
BLUE MOUNTAIN CERVICAL PLATE
K112809
·
KWQ
Orthopedic
·
267d
Cleared
Apr 18, 2012
TWIN PEAKS LUMBAR CAGE
K112696
·
MAX
Orthopedic
·
216d
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Orthopedic
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