9 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aurora
FDA 510(k)
FDA Class 2
·Anesthesiology
TRIAL HEAD DEF.STEM 12/14 D.32 +7
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489313554·
EBI SPINELINK - II SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CONCEIVE PLUS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
QUARTET
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·November 6, 2014
TRANSPORT SERIES
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 18, 2011
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·July 15, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025