8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TalisMann Neuromodulation System
FDA 510(k)
FDA Class 2
·Neurology
CD HORIZON Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
FDA 510(k)
FDA Class 2
·Radiology
BD PRESET¿ ECLIPSE¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·April 1, 2024
MAESTRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBB·July 28, 2011
VIPER2 PEDICLE PREP CANNULA
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code LXH·November 11, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 23, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025