7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMPLATZER TORQVUE EXCHANGE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
FDA 510(k)
FDA Class 1
·General Hospital
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·February 27, 2013
COBAS 311
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CIX·February 8, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN GALWAY·Product code CBK·July 24, 2014