8 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FEMSelect Ltd
FDA registration
FEMSelect Ltd·1 product·🇮🇱 Israel
NeuGuide™
FDA UDI
FEMSELECT LTD·07290017082004·The NeuGuide™ is a single use trans-vaginal dev...
EnPlace Refill Kit
FDA UDI
FEMSELECT LTD·17290017082056·Refill Kit for EnPlace.
EnPlace is a single use...
EnPlace
FDA UDI
FEMSELECT LTD·07290017082028·
ENPLACE
FDA Adverse Event
Injury
·FEMSELECT LTD.·Product code PBQ·December 12, 2023
ENPLACE
FDA Adverse Event
Malfunction
·FEMSELECT LTD·Product code PBQ·March 30, 2026
The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace. Intended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.
FDA Enforcement
Class II
·Ongoing·FEMSelect Ltd·February 9, 2022
The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace. Intended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.
FDA Recall
Open, Classified
·FEMSelect Ltd HaMa'ayan 2 First Floor Modi'in Israel·Product code PBQ·December 13, 2021