9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOWNLEY COX COMB ACETABULAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799001023·
AWBAT-S, AWBAT-D, AWBAT-M
FDA 510(k)
FDA Unclassified
·Unknown
Fit SA
FDA 510(k)
FDA Class 2
·Dental
ASCENT SYSTEM-BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·December 28, 2016
TAPERLOC POR FMRL 12.5X145
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 19, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·October 22, 2010
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·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