7 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITEK YEAST BIOCHEMICAL CARD
FDA 510(k)
FDA Class 1
·Microbiology
SNAPSHOT
FDA 510(k)
FDA Class 2
·Dental
POUCHES, GAS STERILIZATION
FDA 510(k)
FDA Class 2
·General Hospital
FREESTYLE LITE
FDA Adverse Event
Malfunction
·Product code NBW·June 18, 2014
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code MTA·October 7, 2010
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MGB·December 20, 2012
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