7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ORTHOMAG MAGNETIC FORCE SYSTEM
FDA 510(k)
FDA Class 1
·Dental
KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXTRUS 4137
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·June 2, 2014
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 24, 2012
CRYSTALENS
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code NAA·September 22, 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