8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LCM-2-LINAC COUCH-MOUNT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CENTAURI YAG LASER SYST, GYNECOLOGY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SIDE FIRING FIBERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DRILL, AO, STERILE T2 FEMUR 4,2X340 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HTW·December 18, 2012
ENDURANCE BONE CEMENT 80G
FDA Adverse Event
Injury
·9610921 DEPUY CMW·Product code LOD·January 22, 2013
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NVZ·December 14, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 10, 2014
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017