8 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)
FDA 510(k)
FDA Class 2
·Dental
YSIO X.pree
FDA 510(k)
FDA Class 2
·Radiology
NARCOTREND, MODEL COMPACT 4.0
FDA 510(k)
FDA Class 2
·Neurology
DEPUY 3 SYRINGEABLE CEMENT 40G
FDA Adverse Event
Injury
·DEPUY CMW·Product code LOD·December 17, 2010
CORAIL2 STD SIZE 11
FDA Adverse Event
Injury
·DEPUY FRANCE SAS-3003895575·Product code KWA·July 15, 2014
SM104 MSERIES W5TH WHL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·December 21, 2012
BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·January 4, 2022
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021