7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL
FDA 510(k)
FDA Class 2
·Neurology
LEP2000 THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Ophthalmic Software Platform RX
FDA 510(k)
FDA Class 2
·Radiology
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 16, 2014
PROPEX
FDA Adverse Event
Malfunction
·DENTSPLY MAILLEFER·Product code LQY·October 13, 2010
ADVIA CENTAUR XP BR (ASSAY FOR CA 27.29)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MOI·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