510k
Database
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Anesthesiology
132
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566
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162
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310
Ear, Nose, Throat
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
MAX
Intervertebral Fusion Device...
83
NHA
Abutment, Implant, Dental,...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Fitbit, LLC
Medical Device Manufacturer
·
US , San Francisco , CA
Fitbit, LLC - FDA 510(k) Cleared Devices
2 submissions
·
1 cleared
·
Since 2023
2
Total
1
Cleared
1
Denied
FDA 510(k) cleared devices by Fitbit, LLC
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 13, 2025
Body Temperature Software (BTS)
K243778
·
QZA
General Hospital
·
66d
Not Cleared
Dec 15, 2023
Body Temperature Software (BTS)
DEN230050
·
QZA
General Hospital
·
151d
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2
General Hospital
2