8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STEALTHSTATION TREATMENT GUIDANCE PLATFORM
FDA 510(k)
FDA Class 2
·Neurology
COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
FDA 510(k)
FDA Class 2
·Cardiovascular
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PVA FOAM EMBOLIZATION PARTICLES
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·March 26, 2018
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·February 27, 2013
LAPRODRAIN
FDA Adverse Event
SURGIMARK, INC.·Product code JOL·December 17, 2010
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·August 5, 2014
Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma
FDA Recall
Terminated
·Abbott Laboratories Inc.·Product code CIX·March 10, 2010