20 results
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37ms
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Sources: EU EUDAMED, US FDA
iotaMotion, Inc.
Manufacturer
🇺🇸 United States
IOTAMOTION, INC.
FDA registration
IOTAMOTION, INC.·1 product·🇺🇸 United States
iotaSOFT Insertion System
FDA UDI
Iotamotion, Inc.·00850002960044·iotaSOFT Rolling Stand
iotaSOFT Insertion System
FDA UDI
Iotamotion, Inc.·00850002960006·iotaSOFT Drive Unit
iotaSOFT Insertion System
FDA UDI
Iotamotion, Inc.·00850002960020·iotaSOFT Console
iotaSOFT Insertion System
FDA UDI
Iotamotion, Inc.·00850002960068·iotaSOFT Plus Drive Unit
iotaSOFT Insertion System
FDA UDI
Iotamotion, Inc.·00850002960037·iotaSOFT Footpedal
iotaSOFT Insertion System
FDA UDI
Iotamotion, Inc.·00850002960051·iotaSOFT Control Console
DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM
FDA Adverse Event
Malfunction
·IOTAMOTION INC.·Product code QQH·August 30, 2024
DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM
FDA Adverse Event
Malfunction
·IOTAMOTION INC.·Product code QQH·October 27, 2025
DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM
FDA Adverse Event
Malfunction
·IOTAMOTION INC.·Product code QQH·October 10, 2024
DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM
FDA Adverse Event
Malfunction
·IOTAMOTION INC.·Product code QQH·November 29, 2024
DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM
FDA Adverse Event
Malfunction
·IOTAMOTION INC.·Product code QQH·May 1, 2025
DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM
FDA Adverse Event
Malfunction
·IOTAMOTION INC.·Product code QQH·March 10, 2026
DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM
FDA Adverse Event
Malfunction
·IOTAMOTION INC.·Product code QQH·March 9, 2026
DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM
FDA Adverse Event
Malfunction
·IOTAMOTION INC.·Product code QQH·March 10, 2026
DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM
FDA Adverse Event
Malfunction
·IOTAMOTION INC.·Product code QQH·January 16, 2025
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.
FDA Recall
Completed
·Iotamotion Inc·Product code QQH·September 12, 2024
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.
FDA Enforcement
Class III
·Completed·Iotamotion Inc·November 13, 2024
Compliance Management Solutions Europe LTD
Authorized representative
🇧🇬 Bulgaria·12 Manufacturers·66 Devices