7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ORAL STEEL CARTRIDGE SYRINGE
FDA 510(k)
FDA Class 2
·Dental
HEMO-DOP
FDA 510(k)
FDA Class 2
·Radiology
CareSuperb COVID-19 Antigen Home Test
FDA 510(k)
FDA Class 2
·Microbiology
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·June 3, 2014
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·February 4, 2013
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH. LTD. / HUNTINGTON·Product code HQL·December 22, 2010
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024