7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
FDA 510(k)
FDA Class 2
·Hematology
ACIES
FDA 510(k)
FDA Class 2
·Radiology
ACCENT DR RF
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 26, 2013
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·July 29, 2011
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