7 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Withings Sleep Rx
FDA 510(k)
FDA Class 2
·Anesthesiology
Midmark Extraoral Imaging System (EOIS)
FDA 510(k)
FDA Class 2
·Radiology
Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
FDA 510(k)
FDA Class 1
·Clinical Toxicology
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 22, 2011
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR
FDA Adverse Event
Injury
·C.R. BARD, INC.·Product code FTL·July 12, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022