7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Inspire HCR and HCR DUAL cardiotomy reservoirs
FDA 510(k)
FDA Class 2
·Cardiovascular
ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
COMPACT INTUITIV Multiple-Use Pack
FDA 510(k)
FDA Class 2
·Ophthalmic
NOVASURE
FDA Adverse Event
CYTYC SURGICAL SERVICES, INC.·Product code MNB·November 24, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 16, 2011
ALARIS PUMP MODULE
FDA Adverse Event
Injury
·CAREFUSION CORPORATION·Product code FRN·July 17, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025