14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex FiberTape and TigerTape Cerclage Sutures
FDA 510(k)
FDA Class 2
·Orthopedic
Viant AS&O Holdings, LLC
FDA registration
Viant AS&O Holdings, LLC·17 products·🇺🇸 United States
K231485
FDA Adverse Event
Malfunction
·BETA BIONICS, INC.·Product code QFG·October 25, 2025
BIOSOMNIA
FDA 510(k)
FDA Class 2
·Neurology
GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GEI·November 3, 2008
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·August 17, 2011
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 9, 2013
VIDAS MEASLES IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LJB·March 18, 2020
VIDAS MEASLES IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LJB·March 18, 2020
VIDAS MEASLES IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LJB·March 18, 2020
VIDAS MEASLES IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LJB·March 18, 2020
VIDAS MEASLES IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LJB·March 18, 2020
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
FDA Enforcement
Class II
·Terminated·Haag-Streit USA Inc·March 29, 2017