510k
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333
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1068
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270
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809
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148
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628
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1322
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760
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99
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72
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366
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582
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244
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155
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2055
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40
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310
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1585
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132
Categories
GEX
Powered Laser Surgical Instrument
229
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Plate, Fixation, Bone
211
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System, Imaging, Pulsed Doppler,...
208
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Automated Radiological Image...
206
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System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
169
NHA
Abutment, Implant, Dental,...
158
MAX
Intervertebral Fusion Device...
138
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Thoracolumbosacral Pedicle Screw...
135
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American Medical Specialties, Inc.
Medical Device Manufacturer
·
US , Roswell , GA
American Medical Specialties, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1994
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - American Medical Specialties, Inc.
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 09, 1996
K-WIRE
K960482
·
HTY
Orthopedic
·
67d
Cleared
Apr 09, 1996
STEINMAN PIN
K960483
·
HTY
Orthopedic
·
67d
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4
General & Plastic Surgery
2
Orthopedic
2