510k
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1290
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325
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985
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185
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758
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1662
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1073
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117
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82
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7
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408
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726
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316
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194
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2340
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44
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390
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1880
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139
Categories
GEX
Powered Laser Surgical Instrument
278
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System, Image Processing,...
263
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Automated Radiological Image...
246
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Electrosurgical, Cutting &...
231
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Plate, Fixation, Bone
230
IYN
System, Imaging, Pulsed Doppler,...
230
OLO
Orthopedic Stereotaxic Instrument
191
NHA
Abutment, Implant, Dental,...
178
LZA
Polymer Patient Examination Glove
165
MAX
Intervertebral Fusion Device...
159
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Aaxter Co., Ltd.
Medical Device Manufacturer
·
TW , Taipei
Aaxter Co., Ltd. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2011
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aaxter Co., Ltd.
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Mar 16, 2011
AAXTER A3 POSTERIOR SPINAL SYSTEM
K101374
·
MNH
Orthopedic
·
303d
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Orthopedic
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