510k
Database
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Anesthesiology
204
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739
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187
Dental
469
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91
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397
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777
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476
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77
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64
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1
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277
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303
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117
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79
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1478
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26
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153
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1094
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94
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IYN
System, Imaging, Pulsed Doppler,...
167
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Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
131
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Powered Laser Surgical Instrument
127
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System, Image Processing,...
125
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Automated Radiological Image...
112
GEI
Electrosurgical, Cutting &...
105
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Abutment, Implant, Dental,...
105
MAX
Intervertebral Fusion Device...
96
NKB
Thoracolumbosacral Pedicle Screw...
93
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Osstell AB
Medical Device Manufacturer
·
US , Alexandria , VA
Osstell AB - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2008
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Osstell AB
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 22, 2019
Osstell Beacon
K181888
·
EKX
Dental
·
405d
Cleared
Feb 19, 2015
Osstell IDx
K142358
·
EKX
Dental
·
178d
Cleared
Apr 09, 2014
MEGA ISQ
K132401
·
EKX
Dental
·
251d
Cleared
Sep 26, 2008
OSSTELL ISQ IMPLANT STABILITY METER
K082523
·
EKX
Dental
·
24d
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4
Dental
4