7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE
FDA 510(k)
FDA Class 1
·Dental
DENTIN RELIEF
FDA 510(k)
FDA Class 2
·Dental
ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
EON MINI IPG, 16-CHANNEL RECHARGEABLE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 5, 2015
LEAD MODEL UNK
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·February 22, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
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