7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
FELDSTEIN BLEPHAROSTOMY CLIP SQUARE
FDA 510(k)
FDA Class 1
·Ophthalmic
WS(TM) Far-Infrared Therapy Unit, Model KP-B210
FDA 510(k)
FDA Class 2
·Physical Medicine
ICON 35; ICON 45; ICON 60; ICON 30FAF
FDA 510(k)
FDA Class 1
·Physical Medicine
6 SHOOTER SAEED MULTI-BAND LIGATOR
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code MND·April 4, 2014
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·September 26, 2012
PENUMBRA SYSTEM REPERFUSION CATHETERS
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·July 14, 2010
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025