6 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: Israel
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Degania Silicone LTD
Manufacturer
🇮🇱 Israel
Biometrix LTD
Manufacturer
🇮🇱 Israel·1 Importer
TUTTNAUER PRE-VACUUM AUTOCLAVE
FDA 510(k)
FDA Class 2
·General Hospital
Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
FDA 510(k)
FDA Class 2
·General Hospital
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
TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures, to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic / laparoscopic surgery. The trocar may be used with or without visualization for primary and secondary insertions. It is comprised of a single patient use, bladeless Obturator designed to allow penetration and positioning at the required site within the abdomen, and several single use Cannulas, which serve as working channels for the procedure. The Cannulas are pre-loaded with two synthetic absorbable sutures, each attached to a synthetic absorbable anchor. The deployment of the anchors and sutures is achieved by utilizing a mechanism within the Obturator. The Cannula is 115 mm long and is compatible for use with laparoscopic devices of 5 - 12 mm outer diameter.
FDA Enforcement
Class II
·Terminated·Gordian Surgical·November 11, 2020