510k
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180
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1591
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113
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298
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184
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2245
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371
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1813
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Powered Laser Surgical Instrument
261
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255
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236
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System, Imaging, Pulsed Doppler,...
224
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Electrosurgical, Cutting &...
222
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Plate, Fixation, Bone
220
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Orthopedic Stereotaxic Instrument
184
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
151
MAX
Intervertebral Fusion Device...
149
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American Radiosurgery, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
American Radiosurgery, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2006
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - American Radiosurgery, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 05, 2010
EXPLORER 4D TREATMENT PLANNING SYSTEM
K101220
·
MUJ
Radiology
·
186d
Cleared
Jan 11, 2010
EXPLORER 4D TREATMENT PLANNING SYSTEM
K093588
·
MUJ
Radiology
·
53d
Cleared
Apr 06, 2006
ROTATING GAMMA SYSTEM. GAMMA ART-6000
K060314
·
IWB
Radiology
·
57d
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3
Radiology
3