510k
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1281
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313
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969
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183
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1641
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114
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82
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315
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193
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2317
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43
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382
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1862
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139
Categories
GEX
Powered Laser Surgical Instrument
275
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System, Image Processing,...
259
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Automated Radiological Image...
242
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System, Imaging, Pulsed Doppler,...
229
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Plate, Fixation, Bone
228
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Electrosurgical, Cutting &...
227
OLO
Orthopedic Stereotaxic Instrument
188
NHA
Abutment, Implant, Dental,...
176
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Polymer Patient Examination Glove
160
NKB
Thoracolumbosacral Pedicle Screw...
158
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Qualgenix
Medical Device Manufacturer
·
US , Oxford , CT
Qualgenix - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2012
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Qualgenix
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
May 01, 2012
MONT BLANC PEDICLE SCREW SYSTEMS
K112684
·
NKB
Orthopedic
·
229d
Cleared
May 01, 2012
AYERS ROCK CERVICAL CAGE
K112801
·
ODP
Orthopedic
·
217d
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Orthopedic
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