24 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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E-CUBE 12
FDA 510(k)
FDA Class 2
·Radiology
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ORION II (HEAVY DUTY 350 LBS AND 500 LBS)
FDA 510(k)
FDA Class 1
·Physical Medicine
IPC® STYLUS TRANSNASAL BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·February 6, 2015
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Malfunction
·MEDTRONIC, INC·Product code ERL·June 19, 2015
XPS® BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·September 8, 2017
ACCY EF201 IPC FOOT CONTROL ROHS
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code HBE·September 9, 2014
XPS® BUR - UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code EQJ·June 17, 2016
SMARTSET MV ENDURANCE 80G
FDA Adverse Event
Injury
·9610921 DEPUY CMW·Product code LOD·June 21, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·July 21, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014
XOM UNKNOWN ENDO
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code EQJ·May 8, 2015
XPS® HANDPIECE - UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code HBE·November 8, 2016
IPC® FOOTPEDAL
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·March 1, 2016
XPS® HANDPIECE - UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code HBE·October 17, 2017
INVICTUS SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code NKB·April 30, 2025
INDIGO¿ DRILL
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code HBE·February 9, 2015
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M5
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·August 12, 2024
INDIGO¿ BUR - ZEPPELIN - REUSABLE
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code ERL·September 23, 2022
DRILL 3334800 VISAO 80K HANDPIECE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ERL·July 3, 2013