8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
QUANTEX C4
FDA 510(k)
FDA Class 2
·Immunology
GFS Ultimate
FDA 510(k)
FDA Class 2
·Orthopedic
SUNSPOTS PRE-GELLED SURFACE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·February 14, 2013
CE INFUSOR LV 5, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·January 17, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 28, 2014
HOLDING SLEEVE-LONG FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·October 21, 2015
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