11 results
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18ms
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Sources: EU EUDAMED, US FDA
ENDODONTIC ROOT CANAL PLUGGER
FDA 510(k)
FDA Class 1
·Dental
BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NeuGuide
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RETAIN-SLEEVE LONG F/MATRIX 5.5
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·June 7, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 15, 2014
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·December 5, 2012
MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 7, 2010
HOLDING SLEEVE-LONG FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·April 9, 2014
HOLDING SLEEVE-LONG FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·October 21, 2015
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012