510k
Database
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132
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568
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162
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313
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68
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287
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513
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370
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67
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56
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0
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232
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163
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61
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49
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1288
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18
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85
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866
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
84
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Ots Medical , Ltd.
Medical Device Manufacturer
·
IL , Herzliya
Ots Medical , Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Ots Medical , Ltd.
Orthopedic
✕
3
devices
1-3 of 3
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Cleared
Jul 22, 2025
OTS 25-L (100-5)
K251310
·
MBI
Orthopedic
·
85d
Cleared
Jan 23, 2025
OTS 25-L (100-5)
K241234
·
MBI
Orthopedic
·
266d
Cleared
Dec 07, 2023
OTS 25 (100-1)
K233429
·
MBI
Orthopedic
·
57d
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Orthopedic
3