510k
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200
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724
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186
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457
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86
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385
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755
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463
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75
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62
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1
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273
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290
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113
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75
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1467
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26
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149
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1076
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93
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IYN
System, Imaging, Pulsed Doppler,...
164
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Plate, Fixation, Bone
150
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Orthopedic Stereotaxic Instrument
129
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System, Image Processing,...
122
GEX
Powered Laser Surgical Instrument
122
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Automated Radiological Image...
109
GEI
Electrosurgical, Cutting &...
104
NHA
Abutment, Implant, Dental,...
104
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Iba Dosimetry GmbH
Medical Device Manufacturer
·
US , Bartlett , TN
Iba Dosimetry GmbH - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2009
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Iba Dosimetry GmbH
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 17, 2020
myQA iON
K201798
·
LHN
Radiology
·
17d
Cleared
Jan 23, 2020
Blue Phantom PT
K191821
·
LHN
Radiology
·
199d
Cleared
Sep 18, 2009
OMNIPRO INCLINE
K092018
·
IYE
Radiology
·
74d
Filters
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3
Radiology
3