8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
QUIDEL HCG TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CERYX PACEMAKER MODELS 114, 314 & 614
FDA 510(k)
FDA Class 3
·Cardiovascular
RENAFLO HEMOCONCENTRATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·June 25, 2014
INTELLECT CRANIAL NAVIGATION SOFTWARE
FDA Adverse Event
Malfunction
·STRYKER NAVIGATION·Product code HAW·November 5, 2010
ACRYSOF IQ TORIQ
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·December 20, 2012
VANGUARD SSK360DA360 KNEE SYSTEM FEMORAL LEFT-WITH SCREW 65MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 24, 2016
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020