9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SINGLE USE LEE ELECTRODE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
JUGGERKNOT FLEX DRILL BIT
FDA UDI
Biomet Orthopedics, LLC·00880304563988·
JuggerKnot®
FDA UDI
Biomet Orthopedics, LLC·00887868511882·
MTA ANGELUS
FDA 510(k)
FDA Class 2
·Dental
LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
FDA 510(k)
FDA Class 2
·Microbiology
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 10
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·January 11, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·December 1, 2010
5.0MM CANNULATED LOCKING SCREW80MM
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·July 3, 2014
Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 1, 2016