7 results
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21ms
·
Sources: EU EUDAMED, US FDA
EMIT GENTAMICIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MEDCARE SUTURE REMOVAL TRAYS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LH RIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 16, 2014
CONTAK RENEWAL TR
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NKE·October 19, 2010
OPEN SPINE CLAMP DRIVER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 14, 2012
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 23, 2014