12 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEDICLE SCREW MONOAXIAL SCREW 5X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 10, 2019
M.U.S.T. EXTENSION
FDA 510(k)
FDA Class 2
·Orthopedic
MUST PEDICLE SCREW 8X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 22, 2017
PEDICLE SCREW PEDICLE SCREW 7X45 (2 PCS)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWP·July 4, 2018
KUNG SHIN, HMEF SK203
FDA 510(k)
FDA Class 2
·Anesthesiology
HD-IVUS ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SYRINGE 3ML W/SND CURITIBA
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·April 11, 2019
EDS III CSF DRAIN SYS W/O V CATH
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·May 29, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·June 17, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·October 1, 2014
MYSPINE STANDARD DRILL GUIDE T07
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MNI·May 10, 2019
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023