8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CENATOR TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LUMINOUS 250 FIBEROPTIC ILLUMINATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OTI BONE PLUG
FDA 510(k)
FDA Class 2
·Orthopedic
SHARPS CONTAINER
FDA Adverse Event
Malfunction
·POST MEDICAL, INC.·Product code FMI·March 12, 2024
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·January 22, 2013
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
QUARTET
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·July 10, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024