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252
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216
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209
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Orthopedic Stereotaxic Instrument
181
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
148
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Intervertebral Fusion Device...
146
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Sumitomo Heavy Industries, Ltd.
Medical Device Manufacturer
·
US , San Diego , CA
Sumitomo Heavy Industries, Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2013
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sumitomo Heavy Industries, Ltd.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 17, 2016
Sumitomo Proton Therapy System
K160612
·
LHN
Radiology
·
167d
Cleared
Nov 19, 2013
SUMITOMO PROTON THERAPY SYSTEM
K130426
·
LHN
Radiology
·
272d
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Radiology
2