7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
PRECISION GAS MIXER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ASEPTIC TRANSFER SET
FDA 510(k)
FDA Class 2
·General Hospital
FOXCROSS PTA CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·April 30, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 10, 2012
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·A.I.D.D LONGFORD·Product code DHA·August 3, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025