14 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology
FDA 510(k)
FDA Class 2
·Radiology
GM HELIX ACQUA IMPLANT,TI,5.0X16
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·May 16, 2018
TOPACS
FDA 510(k)
FDA Class 2
·Radiology
SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
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
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 15, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 11, 2013
E.S. UNIT, POWER CONTROL
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·September 9, 2008