7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
KODAK EKTASCAN LASER PRINTER DIGITAL, MODEL 1000
FDA 510(k)
FDA Class 2
·Radiology
RIA-GNOST FERRITIN
FDA 510(k)
FDA Class 2
·Immunology
NOVASURE ABLATION
FDA Adverse Event
Injury
·Product code MNB·June 20, 2014
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·December 10, 2012
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024