6 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.
FDA Enforcement
Class II
·Terminated·Implant Direct Sybron Manufacturing, LLC·December 16, 2015
SwishTapered Implant
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing, LLC·Product code DZE·December 12, 2016
KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3 Xpander), catalog number KPT1502, manufactured by Medtronic Spine LLC. Device is used to access vertebral body during balloon kyphoplasty, a procedure designed to reduce and stabilize vertebral body compression fractures (VCFS).
FDA Recall
Terminated
·Kyphon Inc·Product code LXH·June 23, 2008
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing, LLC·Product code DZE·May 2, 2017
DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing, LLC·Product code NHA·October 28, 2015
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
FDA Recall
Terminated
·CoreLink LLC·Product code MAX·October 20, 2022