8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
I81 CITE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
NEXT GENERATION LASER
FDA 510(k)
FDA Class 2
·Ophthalmic
Pre-Formed Penile Silicone Block
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PENUMA IMPLANT
FDA Adverse Event
Injury
·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 22, 2014
CELL-DYN EMERALD DILUENT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·October 8, 2010
UNKNOWN DEPUY ASR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 10, 2012
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015