7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST
FDA 510(k)
FDA Class 1
·Microbiology
SITE-RITE 5 ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Manual Wheelchair (SYIV100A008)
FDA 510(k)
FDA Class 1
·Physical Medicine
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 15, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·February 9, 2013
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·January 7, 2011
RAIL CLAMP ASSEMBLY
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·May 22, 2019