15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Summit Spine Channel Cervical Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
BIO-CLAD ALL POLY CUP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304256088·
GM HELIX ACQUA IMPLANT,TI,5.0X16
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·May 16, 2018
DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
FDA 510(k)
FDA Class 2
·Neurology
ZENOSTAR MAGIC GLAZE
FDA 510(k)
FDA Class 2
·Dental
GM HELIX IMPLANT 4.3X13
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 6, 2018
GM HELIX IMPLANT 4.3X13
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 22, 2018
GM DRIVE ACQUA IMPLANT 3.5X8 MM
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·August 29, 2018
GM HELIX ACQUA IMPLANT 3.75X11.5
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·April 24, 2018
GM HELIX IMPLANT 3.5X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 29, 2018
GM HELIX ACQUA IMPLANT 3.5X11.5
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·April 24, 2018
GM DRIVE IMPLANT 3.5X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·April 20, 2018
MITEK EXPRESSEW III NEEDLE
FDA Adverse Event
Injury
·DEPUY MITEK·Product code LXH·October 10, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 11, 2013
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 15, 2011