7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ACUFEX SHOULDER HOLDER
FDA 510(k)
FDA Class 1
·Orthopedic
COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1
FDA 510(k)
FDA Class 2
·Neurology
SYSTEM CALIBRATER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RSP SHOULDER
FDA Adverse Event
Injury
·ENCORE MEDICAL, L.P.·Product code KWS·May 30, 2014
DXTEND GLENOSPHERE STD D38MM
FDA Adverse Event
Injury
·DEPUY FRANCE·Product code HSD·November 21, 2012
MANTIS CANNULATED MODULAR AWL
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code LXH·September 7, 2010
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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