9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OTW Takeru PTCA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
PRIMADO2 TOTAL SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
FASTPACK HCG IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORP.·Product code NIQ·August 4, 2006
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 3, 2025
UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL S.A.·Product code GFA·June 5, 2013
HUDSON HEATED-WIRE VENTILATOR CIRCUIT 18" 21 V
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTT·June 23, 2011
ANALYTICAL E MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·September 19, 2008
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code HBC·March 26, 2018