510k
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400
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1211
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302
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911
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173
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716
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1547
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112
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79
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395
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672
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292
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179
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2202
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42
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361
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1779
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137
Categories
GEX
Powered Laser Surgical Instrument
253
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System, Image Processing,...
238
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Automated Radiological Image...
232
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System, Imaging, Pulsed Doppler,...
222
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Electrosurgical, Cutting &...
218
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Plate, Fixation, Bone
217
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Orthopedic Stereotaxic Instrument
182
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
150
MAX
Intervertebral Fusion Device...
146
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Hans Biomed Corp.
Medical Device Manufacturer
·
US , Chevy Chase , MD
Hans Biomed Corp. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2012
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hans Biomed Corp.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 21, 2016
MaxiGen
K152077
·
MQV
Orthopedic
·
269d
Cleared
Mar 11, 2016
BellaFuse
K151271
·
MQV
Orthopedic
·
303d
Cleared
Nov 15, 2012
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
K113728
·
MBP
Orthopedic
·
332d
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4
Orthopedic
3
Dental
1