14 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SHABAN 9865 IL#78637 JUNCTION BLOC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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
BIOANCHOR WITH DISPOSABLE DRIVER
FDA 510(k)
FDA Class 2
·Orthopedic
Resonic Rapid Acoustic Pulse Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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
M2A-MAGNUM PF CUP 54ODX48ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 27, 2014
BRILLIANCE 64
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·November 5, 2012
CAPSURE SP
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2015
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018