510k
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Anesthesiology
208
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743
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187
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473
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92
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398
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784
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482
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77
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64
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1
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278
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310
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121
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81
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1485
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26
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155
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1105
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95
Categories
IYN
System, Imaging, Pulsed Doppler,...
168
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
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Powered Laser Surgical Instrument
128
LLZ
System, Image Processing,...
126
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Automated Radiological Image...
114
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
105
MAX
Intervertebral Fusion Device...
98
NKB
Thoracolumbosacral Pedicle Screw...
93
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Black Box Medical
Medical Device Manufacturer
·
US , Midland , TX
Black Box Medical - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Black Box Medical
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 23, 2018
FUSE Pedicle Screw System
K182283
·
NKB
Orthopedic
·
61d
Cleared
Jul 27, 2018
Stowe Pedicle Screw System
K181554
·
NKB
Orthopedic
·
44d
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Orthopedic
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