7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SPECTACLE SUNGLASSES(NON-PRESCRIPTION)
FDA 510(k)
FDA Class 1
·Ophthalmic
ArcadiusXP C Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
ANCHOR PLUS/NEO ANCHOR PLUS
FDA 510(k)
FDA Class 2
·Dental
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 9, 2013
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·January 10, 2011
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·July 23, 2014
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024