7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MYOLEX
FDA 510(k)
FDA Class 2
·Immunology
DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
NON ADHERENT BANDAGE/SHEET
FDA 510(k)
FDA Unclassified
·Unknown
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code GZB·June 10, 2014
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 11, 2010
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 1, 2012
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020