510k
Database
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Anesthesiology
386
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1201
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294
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892
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165
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708
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1521
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904
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109
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78
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1
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392
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663
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285
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176
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2192
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42
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356
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1749
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137
Categories
GEX
Powered Laser Surgical Instrument
253
QIH
Automated Radiological Image...
231
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System, Image Processing,...
227
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System, Imaging, Pulsed Doppler,...
221
HRS
Plate, Fixation, Bone
217
GEI
Electrosurgical, Cutting &...
211
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
149
MAX
Intervertebral Fusion Device...
146
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Ht Medical, LLC
Medical Device Manufacturer
·
US , Tulsa , OK
Ht Medical, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2016
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ht Medical, LLC
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 12, 2017
NeoFuse Ti3D PLIF/TLIF/Cervical Interbody
K170318
·
ODP
Orthopedic
·
161d
Cleared
Apr 25, 2017
NeoFuse HA Enhanced PLIF/TLIF
K170511
·
MAX
Orthopedic
·
63d
Cleared
May 06, 2016
NeoFuse HA Enhanced PLIF/TLIF
K153615
·
MAX
Orthopedic
·
141d
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Orthopedic
3