7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
AMBULATOR
FDA 510(k)
FDA Class 1
·Physical Medicine
AVIE TOTAL HB TEST SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL
FDA 510(k)
FDA Class 2
·Ophthalmic
UMBILICAL CATHETER
FDA Adverse Event
Malfunction
·VYGON·Product code FOS·February 17, 2021
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·January 16, 2013
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NIK·July 9, 2014