510k
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743
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472
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92
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398
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783
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479
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77
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64
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277
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309
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121
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81
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1484
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26
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155
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1102
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95
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IYN
System, Imaging, Pulsed Doppler,...
168
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Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
131
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128
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126
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Automated Radiological Image...
113
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Electrosurgical, Cutting &...
105
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Abutment, Implant, Dental,...
105
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Intervertebral Fusion Device...
98
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Thoracolumbosacral Pedicle Screw...
93
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Safeop Surgical, Inc.
Medical Device Manufacturer
·
US , Amherst , MA
Safeop Surgical, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2014
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Safeop Surgical, Inc.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 22, 2019
The EPAD 2 System
K182542
·
GWF
Neurology
·
158d
Cleared
Jan 24, 2014
EPAD
K132616
·
GWF
Neurology
·
156d
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2
Neurology
2