9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
KALLESTEAD TOTAL IGE MICROPLATE KIT
FDA 510(k)
FDA Class 2
·Immunology
SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SUNTOUCH TOPICAL HEMOSTATIC DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
OMNIPOD 5 CONTROLLER
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code QFG·June 5, 2024
UNK RIGHT ABG II NECK
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·January 7, 2013
SYNVISC ONE (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·November 3, 2010
SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·July 3, 2014
M2A 38MMX58MM CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 13, 2022
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021