7 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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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
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).
FDA Recall
Completed
·Mako Surgical Corporation·Product code OLO·October 23, 2020
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).
FDA Enforcement
Class II
·Completed·Mako Surgical Corporation·November 25, 2020
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
FDA Recall
Completed
·Caire, Inc.·Product code CAW·October 4, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
FDA Recall
Completed
·Caire, Inc.·Product code CAW·October 4, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
FDA Recall
Completed
·Caire, Inc.·Product code CAW·October 4, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
FDA Recall
Completed
·Caire, Inc.·Product code CAW·October 4, 2024