8 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ROOT CANAL FILLING CEMENT
FDA 510(k)
FDA Class 2
·Dental
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909143252·REVELATION DIAMOND 868-024M - 5 PACK
AHL, ITE MODEL AMERICAN
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
COAG-1 PT-NC TEST CARD
FDA 510(k)
FDA Class 2
·Hematology
ENERGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 14, 2013
ONE TOUCH LANCING DEVICE
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 3, 2010
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·July 3, 2014
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021