14 results
·
20ms
·
Sources: EU EUDAMED, US FDA
KNEE WALKER
FDA 510(k)
FDA Class 1
·Physical Medicine
UNKNOWN BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020
UNKNOWN BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020
UNKNOWN BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020
UNKNOWN BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020
FLUID LEVEL MONITOR
FDA 510(k)
FDA Class 2
·General Hospital
IMAGE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
XPS® BUR - UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·March 9, 2017
DRILL 3055601 SKEETER OTO-TOOL
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC·Product code ERL·January 11, 2013
XPS® BUR - UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·March 8, 2017
UNIVERSAL STEM 75X20MM FLUTED
FDA Adverse Event
Injury
·DEPUY-RAYNHAM,A DIV. OF DEPUY ORTHOPAEDICS 1219655·Product code NJL·May 27, 2014
COBLATOR II SURGERY SYSTEM
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GEI·November 5, 2012
STERLING ES PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·September 14, 2010
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019