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542
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Ear, Nose, Throat
248
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972
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2194
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2047
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126
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99
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469
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965
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433
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2923
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52
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515
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2442
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155
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Polymer Patient Examination Glove
409
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388
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358
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356
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305
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299
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276
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Plate, Fixation, Bone
275
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Orthopedic Stereotaxic Instrument
227
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Intervertebral Fusion Device...
220
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Iotamotion, Inc.
Medical Device Manufacturer
·
US , Iowa City , IA
Iotamotion, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
1 cleared
·
Since 2021
2
Total
1
Cleared
1
Denied
FDA 510(k) Regulatory Record - Iotamotion, Inc.
Ear, Nose, Throat
✕
2
devices
1-2 of 2
Filters
Cleared
CT
Jan 09, 2026
iotaSOFT® Insertion System
K252339
·
QQH
Ear, Nose, Throat
·
165d
Not Cleared
Oct 01, 2021
iotaSOFT Insertion System - Drive Unit, Controller and Accessories
DEN190055
·
QQH
Ear, Nose, Throat
·
653d
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Ear, Nose, Throat
2