9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SURGIFLATOR-20 ECU
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Visualase Thermal Therapy System
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MENTOR SILTEX ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 7, 2024
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 27, 2013
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·August 5, 2014
MYNX VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·February 8, 2011
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·April 29, 2025
L.C. 5000/CE 2-CHANNEL PUMP (50/CASE)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·August 22, 2013