7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HYDRON ROOT CANAL FILLING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)
FDA 510(k)
FDA Class 2
·Orthopedic
VenaCure EVLT NeverTouch Procedure Kit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNICEL® DXC 800 PRO SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·April 25, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 29, 2007
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·September 28, 2012
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021