6 results
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41ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
FDA Recall
Terminated
·Capso Vision, Inc.·Product code NEZ·February 26, 2020
CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
FDA Recall
Terminated
·Capso Vision, Inc.·Product code NEZ·July 3, 2019
CapsoCAM Plus, UDI: 00867770000209
FDA Recall
Terminated
·Capso Vision, Inc.·Product code NEZ·October 18, 2019
The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
FDA Enforcement
Class II
·Terminated·Capso Vision, Inc.·July 15, 2020
CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
FDA Enforcement
Class II
·Terminated·Capso Vision, Inc.·May 27, 2020
CapsoCAM Plus, UDI: 00867770000209
FDA Enforcement
Class II
·Terminated·Capso Vision, Inc.·May 6, 2020