7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER
FDA 510(k)
FDA Class 2
·Cardiovascular
HIGH FREQUENCY EPILATOR CB-2
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BONE FIXATION WIRE (KIRSCHNER WIRE)
FDA 510(k)
FDA Class 2
·Orthopedic
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 2, 2014
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·October 13, 2010
UNKNOWN DEPUY ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·December 14, 2012
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024