8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
Q-TIPS
FDA 510(k)
FDA Class 1
·General Hospital
Alinity m Integrated Reaction Units (IRU)
FDA Enforcement
Class II
·Terminated·Abbott Molecular, Inc.·March 9, 2022
SHEA TORP, OTOLOGY IMPLANT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LERADO, POWER WHEELCHAIR, PB
FDA 510(k)
FDA Class 2
·Physical Medicine
Alinity m Integrated Reaction Units (IRU)
FDA Recall
Terminated
·Abbott Molecular, Inc.·Product code OOI·February 11, 2022
PENUMBRA SYSTEM REPERFUSION CATHETER 041
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·October 3, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 12, 2007
THERAKOS CELLEX PHOTOPHERESIS SYSTEM
FDA Adverse Event
Malfunction
·THERAKOS, INC.·Product code LNR·February 18, 2014