7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
CATH KIT, URINE SPECIMEN
FDA 510(k)
FDA Class 1
·Pathology
ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Playtex Stella Tampons
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 10, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 7, 2014
COAGUCHEK XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·September 21, 2007
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025