7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
TRICON-P TIBIAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
MDT Navigable Brain Biopsy Cannula
FDA 510(k)
FDA Class 2
·Neurology
LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GYNECARE VERSAPOINT II BIPOLAR ELECTROSURGERY SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code HIH·June 2, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·November 21, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 24, 2010
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