7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PRESSURE LIMIT CONTROL
FDA 510(k)
FDA Class 2
·Anesthesiology
POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOMETRIAL PIPELLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·June 16, 2014
MP20 INTELLIVUE PATIENT MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·October 12, 2010
STEM
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·December 14, 2012
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