15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CRISA
FDA 510(k)
FDA Class 1
·Radiology
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
A1CNOW FOR HOME AND PROFESSIONAL USE
FDA 510(k)
FDA Class 2
·Hematology
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
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
10MM INZII RETRIEVAL SYSTEM 10/BOX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code GCJ·May 27, 2014
5.2MM TI DUAL-OPENING SCREW 30MM THRD LENGTH F/6.0MM RODS
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·November 15, 2012
QUANTUM MAVERICK BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·September 14, 2010
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·August 14, 2019
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