8 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Tua Face Fitness / Tua Trend Face
FDA 510(k)
FDA Class 2
·Neurology
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583032733·ET40, KIT 10 NFM 85 PB BE ENCHANT 40
HBIDB - HUMAN BRIAN INDEX SOFTWARE
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 20, 2013
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·October 7, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 4, 2011
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