7 results
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26ms
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Sources: EU EUDAMED, US FDA
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Country: Israel
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Biosense Webster (Israel) Ltd.
Manufacturer
🇮🇱 Israel·2 Importers
The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
FDA Enforcement
Class I
·Terminated·Lumenis Limited·February 20, 2013
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
SMV DSI, System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026
MAXXUS, System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026
SMV BodyTrack, System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026
SMV DSX New Line, System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026