9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Powder Free White, Black, and Purple Nitrile Examination Glove
FDA 510(k)
FDA Class 1
·General Hospital
Ventilator, Non-continuous (Respirator)
FDA 510(k)
FDA Class 2
·Anesthesiology
ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
FDA 510(k)
FDA Class 2
·Dental
HEMOCONCENTRATOR
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code KDI·August 20, 2019
PSX INTERBODY SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025
PFC SIGMARP STB TB IN 5 10.0
FDA Adverse Event
Injury
·DEPUY IRELAND 961667·Product code NJL·November 6, 2014
VIASYS
FDA Adverse Event
Death
·CAREFUSION·Product code CBK·August 26, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022