9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
KEANE MOBILITY BED
FDA 510(k)
FDA Class 2
·Physical Medicine
GC Initial™
FDA UDI
Gc America Inc.·J0228730471·GC Initial™ AL Opaqus Dentin Mod. ODM-1, 20g
Legacy™ Plastic Engaging Temporary Abutment-Concave Profile
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307111658·
Legacy™ Plastic Engaging Temporary Abutment-Concave Profile
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307134077·
The Solstice OCT System
FDA 510(k)
FDA Class 2
·Orthopedic
APROXI 1100 AND 4000 SERIES DENTAL INLAYS
FDA 510(k)
FDA Class 2
·Dental
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 13, 2014
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·October 14, 2010
MAVERICK2 BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·December 13, 2012