7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRANSGROW
FDA 510(k)
FDA Class 2
·Microbiology
SOS BLOODLESS NEEDLE
FDA 510(k)
FDA Class 2
·Cardiovascular
TURBO-RAST SPECIFIC IGE ASSAY
FDA 510(k)
FDA Class 2
·Immunology
ALIGN R URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code OTN·January 28, 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·November 24, 2010
POSTERIOR VAGINAL MESH
FDA Adverse Event
Injury
·Product code OTN·July 10, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024