6 results
·
26ms
·
Sources: EU EUDAMED, US FDA
FLOSCOPE MICRODOP
FDA 510(k)
FDA Class 2
·Cardiovascular
FREELITE KAPPA FREE KIT
FDA 510(k)
FDA Class 2
·Immunology
Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit
FDA 510(k)
FDA Class 2
·Microbiology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 11, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 30, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·July 2, 2014