7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOTIS BORDET GENGOU AGAR
FDA 510(k)
FDA Class 1
·Microbiology
CRYSTALVIEW R200
FDA 510(k)
FDA Class 2
·Radiology
ET Hybrid Abutment
FDA 510(k)
FDA Class 2
·Dental
SENSIA D
FDA Adverse Event
Malfunction
·MEDTRONIC SINGAPORE OPERATIONS·Product code NVZ·June 10, 2014
ACCU-CHEK ® INFORM METER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·December 10, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·June 23, 2015
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021