7 results
·
23ms
·
Sources: EU EUDAMED, US FDA
SILIMED SILICONE CARVING BLOCK
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NEOSS ACCESS ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
HEMOGLOBIN, TESTING SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·February 27, 2013
SENSOR, MMT-7002C, 10PK, GLUCOSE, BSA, 17L
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·February 2, 2011
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 5, 2014
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015