7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MICROLAB AT
FDA 510(k)
FDA Class 1
·Microbiology
S4 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Discovery Pico, Discovery Pico Plus
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·April 17, 2014
TECNIS MULTIFOCAL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·October 16, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 13, 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